VAY736 ( DrugBank: - )
9 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 3 |
| 35 | 天疱瘡 | 2 |
| 46 | 悪性関節リウマチ | 2 |
| 49 | 全身性エリテマトーデス | 8 |
| 53 | シェーグレン症候群 | 20 |
| 61 | 自己免疫性溶血性貧血 | 2 |
| 63 | 特発性血小板減少性紫斑病 | 6 |
| 85 | 特発性間質性肺炎 | 6 |
| 95 | 自己免疫性肝炎 | 9 |
13. 多発性硬化症／視神経脊髄炎
臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2013-002324-16-CZ (EUCTR) | 13/06/2014 | 08/01/2014 | Study of efficacy and safety of VAY736 in patients with relapsing-remitting multiple sclerosis | A randomized, partially blind, placebo-controlled, proof-of-concept study to assess the effect of a single infusion of VAY736 on disease activity as measured by brain MRI scans in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: VAY736 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | United States;Czech Republic;Poland;Ukraine;Russian Federation | ||
| 2 | EUCTR2013-002324-16-PL (EUCTR) | 04/06/2014 | 09/04/2014 | Study of efficacy and safety of VAY736 in patients with relapsing-remitting multiple sclerosis | A randomized, partially blind, placebo-controlled, proof-of-concept study to assess the effect of a single infusion of VAY736 on disease activity as measured by brain MRI scans in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: VAY736 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | United States;Czech Republic;Poland;Ukraine;Russian Federation | ||
| 3 | NCT02038049 (ClinicalTrials.gov) | December 20, 2013 | 14/1/2014 | A Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis | A Randomized, Partially Blind, Placebo-controlled, Proof-of-concept Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity as Measured by Brain MRI Scans in Patients With Relapsing-remitting Multiple Sclerosis | Relapse Remitting Multiple Sclerosis | Drug: VAY736;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 55 Years | All | 8 | Phase 2 | United States;Czechia;Ukraine;Czech Republic;Germany;Poland;Russian Federation |
35. 天疱瘡
臨床試験数 : 99 / 薬物数 : 124 - (DrugBank : 36) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 169
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01930175 (ClinicalTrials.gov) | December 18, 2013 | 23/8/2013 | Study of Efficacy and Safety of VAY736 in Patients With Pemphigus Vulgaris | A Randomized, Partial-blind, Placebo-controlled Trial Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of VAY736 in the Treatment of Patients With Pemphigus Vulgaris | Pemphigus Vulgaris | Drug: VAY736;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 20 Years | 70 Years | All | 13 | Phase 2 | United States;Austria;Bulgaria;Taiwan;Germany;Israel;Italy;United Kingdom |
| 2 | EUCTR2013-001217-33-AT (EUCTR) | 25/11/2013 | 03/10/2013 | Study of efficacy and safety of VAY736 in patients with Pemphigus vulgaris | A randomized, partial-blind, placebo-controlled trial evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of VAY736 in the treatment of patients with pemphigus vulgaris | Pemphigus vulgaris MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: ianalumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 32 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Taiwan;Austria;Bulgaria |
46. 悪性関節リウマチ
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03574545 (ClinicalTrials.gov) | December 19, 2018 | 21/6/2018 | Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis | A Randomized, Open Label, Multiple Dose, Parallel Group Study to Assess the Safety and Pharmacokinetic Comparability of Two VAY736 Drug Products in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: ianalumab | Novartis Pharmaceuticals | NULL | Active, not recruiting | 18 Years | 65 Years | All | 48 | Phase 1 | Germany;Jordan |
| 2 | NCT02675803 (ClinicalTrials.gov) | December 20, 2010 | 9/7/2015 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of VAY736 in Rheumatoid Arthritis Patients | A Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VAY736 in Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Biological: VAY736;Biological: VAY736 placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 65 | Phase 1 | Germany |
49. 全身性エリテマトーデス
臨床試験数 : 993 / 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2022-002691-36-SK (EUCTR) | 07/02/2023 | 24/10/2022 | Phase 3 study to evaluate two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1) | A randomized, double-blind, parallel group, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1) | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: IANALUMAB Other descriptive name: VAY736 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 406 | Phase 3 | Hungary;United States;Czechia;Japan;Thailand;Portugal;Spain;Canada;Czech Republic;Turkey;China;Brazil;Guatemala;Poland;South Africa;Slovakia;Israel;Bulgaria | ||
| 2 | EUCTR2022-002691-36-CZ (EUCTR) | 27/01/2023 | 23/11/2022 | Phase 3 study to evaluate two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1) | A randomized, double-blind, parallel group, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1) | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: IANALUMAB Other descriptive name: VAY736 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 406 | Phase 3 | Portugal;United States;Czechia;Slovakia;Thailand;Spain;Guatemala;Turkey;Israel;Hungary;Czech Republic;Canada;Brazil;Poland;South Africa;Bulgaria;China;Japan | ||
| 3 | EUCTR2022-002691-36-ES (EUCTR) | 22/12/2022 | 01/11/2022 | Phase 3 study to evaluate two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1) | A randomized, double-blind, parallel group, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1) | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: IANALUMAB Other descriptive name: VAY736 | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 406 | Phase 3 | Portugal;United States;Czechia;Slovakia;Spain;Thailand;Guatemala;Turkey;Israel;Hungary;Canada;Brazil;Poland;South Africa;Bulgaria;China;Japan | ||
| 4 | EUCTR2018-001508-12-FR (EUCTR) | 05/02/2019 | 13/11/2018 | Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | Systemic lupus erythematosus (SLE) MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 Product Code: CFZ533 INN or Proposed INN: iscalimab Other descriptive name: CFZ533 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of | ||
| 5 | NCT03656562 (ClinicalTrials.gov) | December 19, 2018 | 19/7/2018 | Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients | A Placebo-controlled, Patient and Investigator Blinded, Randomized Parallel Cohort Study to Assess Pharmacodynamics, Pharmacokinetics, Safety, Tolerability and Preliminary Clinical Efficacy of VAY736 and CFZ533 in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) | Drug: VAY736;Drug: VAY736 Placebo;Drug: CFZ533;Drug: CFZ533 Placebo | Novartis Pharmaceuticals | NULL | Active, not recruiting | 18 Years | 75 Years | All | 107 | Phase 2 | Spain;Taiwan;Thailand;Argentina;Australia;China;Czechia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Poland;Russian Federation;United States |
| 6 | EUCTR2018-001508-12-ES (EUCTR) | 12/12/2018 | 09/10/2018 | Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | Systemic lupus erythematosus (SLE) MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 Product Code: CFZ533 INN or Proposed INN: iscalimab Other descriptive name: CFZ533 | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of | ||
| 7 | EUCTR2018-001508-12-DE (EUCTR) | 05/12/2018 | 28/08/2018 | Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | A placebo-controlled, patient and investigator blinded, randomized parallelcohort study to assess pharmacodynamics, pharmacokinetics, safety,tolerability and preliminary clinical efficacy of VAY736 and CFZ533 inpatients with systemic lupus erythematosus (SLE) | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 Product Code: CFZ533 INN or Proposed INN: iscalimab Other descriptive name: CFZ533 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | United States;Czechia;Taiwan;Spain;Thailand;Israel;Russian Federation;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of | ||
| 8 | EUCTR2018-001508-12-CZ (EUCTR) | 02/11/2018 | 28/08/2018 | Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | A placebo-controlled, patient and investigator blinded, randomized parallelcohort study to assess pharmacodynamics, pharmacokinetics, safety,tolerability and preliminary clinical efficacy of VAY736 and CFZ533 inpatients with systemic lupus erythematosus (SLE) | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 Product Code: CFZ533 INN or Proposed INN: iscalimab Other descriptive name: CFZ533 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 135 | Phase 2 | Argentina;Russian Federation;Hungary;Japan;Thailand;Spain;Czech Republic;China;Taiwan;Korea, Republic of;Poland;Israel;Australia;France;Germany |
53. シェーグレン症候群
臨床試験数 : 305 / 薬物数 : 325 - (DrugBank : 104) / 標的遺伝子数 : 58 - 標的パスウェイ数 : 188
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05349214 (ClinicalTrials.gov) | August 4, 2022 | 8/4/2022 | Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome | A Randomized, Double-blind, Placebo Controlled, 3-arm Multicenter Phase 3 Study to Assess the Efficacy and Safety of Ianalumab in Patients With Active Sjogren's Syndrome (NEPTUNUS-2) | Sjogren Syndrome | Biological: VAY736;Other: Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 489 | Phase 3 | United States;Argentina;Australia;Brazil;Bulgaria;Canada;China;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Lebanon;Mexico;Poland;Romania;Slovakia;Spain;Sweden;Taiwan;United Kingdom |
| 2 | EUCTR2021-005687-22-SK (EUCTR) | 01/08/2022 | 12/05/2022 | A clinical study to investigate ianalumab is effective and safe in the treatment of active Sjögren`s syndrome | A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjögren’s syndrome (NEPTUNUS-2) - NEPTUNUS-2 | Active Sjögren’s syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: IANALUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 489 | Phase 3 | United States;Taiwan;Slovakia;Greece;Spain;Lebanon;Israel;Chile;Colombia;Italy;India;France;Australia;Peru;South Africa;China;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 3 | NCT05350072 (ClinicalTrials.gov) | July 28, 2022 | 7/4/2022 | Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome | A Randomized, Double-blind, Placebo Controlled, 2-arm Multicenter Phase 3 Study to Assess the Efficacy and Safety of Ianalumab in Patients With Active Sjogren's Syndrome (NEPTUNUS-1) | Sjogren Syndrome | Biological: VAY736;Other: Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 285 | Phase 3 | United States;Austria;Brazil;China;Czechia;France;Germany;Guatemala;Korea, Republic of;Lithuania;Poland;Portugal;Singapore;Spain;Turkey |
| 4 | EUCTR2021-005687-22-HU (EUCTR) | 24/05/2022 | 11/04/2022 | A clinical study to investigate ianalumab is effective and safe in the treatment of active Sjögren`s syndrome | A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjögren’s syndrome (NEPTUNUS-2) - NEPTUNUS-2 | Active Sjögren’s syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: IANALUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 489 | Phase 3 | United States;Taiwan;Slovakia;Greece;Spain;Lebanon;Israel;Chile;Colombia;Italy;India;France;Australia;Peru;South Africa;China;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 5 | EUCTR2020-005055-20-FR (EUCTR) | 25/04/2022 | 10/11/2021 | A clinical study with biopsy to investigate how ianalumab works in Sjögren`s and how safe it is | An open-label, non-randomized, biopsy-based mechanistic study on efficacy, pharmacokinetics, pharmacodynamics, safety and tolerability of ianalumab in patients with Sjögren's syndrome - Biopsy-based mechanistic study | Sjögren's syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ianalumab Product Code: VAY736 INN or Proposed INN: IANALUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | France | ||
| 6 | EUCTR2016-003292-22-IT (EUCTR) | 20/11/2017 | 25/05/2021 | Study of safety and efficacy of ianalumab in patients with primary Sjogren's Syndrome (pSS). | A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjögren’s Syndrome. - Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS) | Primary Sjogren's syndrome. MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: [VAY736] INN or Proposed INN: IANALUMAB | NOVARTIS PHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Portugal;United States;Taiwan;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Germany;Netherlands;Japan | ||
| 7 | EUCTR2016-003292-22-PL (EUCTR) | 28/09/2017 | 23/08/2017 | Study of safety and efficacy of ianalumab in patients with primarySjogren's Syndrome (pSS) | A randomized, double-blind, placebo-controlled multicenter phase 2 doseranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren's Syndrome | Primary Sjogren’s syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 antibody | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Germany;Netherlands;Japan | ||
| 8 | EUCTR2016-003292-22-NL (EUCTR) | 25/07/2017 | 19/04/2017 | Study of safety and efficacy of ianalumab in patients with primarySjogren's Syndrome (pSS) | A randomized, double-blind, placebo-controlled multicenter phase 2 doserangingstudy to assess the safety and efficacy of multiple ianalumab dosesadministered subcutaneously in patients with moderate to severe primarySjogren's Syndrome | Primary Sjogren’s syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 antibody | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Portugal;United States;Taiwan;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan | ||
| 9 | EUCTR2016-003292-22-BE (EUCTR) | 17/07/2017 | 26/04/2017 | Study of safety and efficacy of ianalumab in patients with primary Sjogren's Syndrome (pSS) | A randomized, double-blind, placebo-controlled multicenter phase 2 doseranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren's Syndrome. | Primary Sjogren’s syndrome MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ianalumab Product Code: VAY736 INN or Proposed INN: Ianalumab Other descriptive name: VAY736 antibody | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan | ||
| 10 | EUCTR2016-003292-22-HU (EUCTR) | 29/06/2017 | 20/04/2017 | Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS) | A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome | Primary Sjogren’s syndrome MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: Not established Other descriptive name: VAY736 antibody | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;United States;Portugal;Taiwan | ||
| 11 | NCT02962895 (ClinicalTrials.gov) | June 27, 2017 | 3/11/2016 | Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS) | Study of Safety and Efficacy of Multiple VAY736 Doses in Patients With Moderate to Severe Primary Sjogren's Syndrome (pSS) | Primary Sjogren Syndrome | Biological: VAY736;Other: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 192 | Phase 2 | United States;Argentina;Austria;Belgium;Chile;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Portugal;Romania;Russian Federation;Spain;Taiwan;United Kingdom |
| 12 | EUCTR2016-003292-22-AT (EUCTR) | 19/06/2017 | 17/05/2017 | A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren’s Syndrome | A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren’s Syndrome | Primary Sjogren’s syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 antibody | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan | ||
| 13 | EUCTR2016-003292-22-FR (EUCTR) | 09/06/2017 | 11/04/2017 | Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS) | A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome | Primary Sjogren’s syndrome MedDRA version: 19.1;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: Not established Other descriptive name: VAY736 antibody | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan | ||
| 14 | EUCTR2016-003292-22-DE (EUCTR) | 06/06/2017 | 06/03/2017 | Study of safety and efficacy of ianalumab in patients with primary Sjogren’s Syndrome (pSS) | A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren’s Syndrome | Primary Sjogren’s syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 antibody | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan | ||
| 15 | EUCTR2016-003292-22-PT (EUCTR) | 05/06/2017 | 20/03/2017 | Study of safety and efficacy of ianalumab in patients with primary Sjogren’s Syndrome (pSS) | A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab dosesadministered subcutaneously in patients with moderate to severe primary Sjogren’s Syndrome | Primary Sjogren’s syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 antibody | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Portugal;United States;Taiwan;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan | ||
| 16 | EUCTR2016-003292-22-GB (EUCTR) | 26/05/2017 | 20/03/2017 | Study of safety and efficacy of ianalumab in patients with primary Sjogren’s Syndrome (pSS) | A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjögren’s Syndrome | Primary Sjogren’s syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 antibody | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan | ||
| 17 | EUCTR2016-003292-22-ES (EUCTR) | 06/04/2017 | 10/03/2017 | Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS) | A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome | Primary Sjogren’s syndrome MedDRA version: 19.1;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: Not established Other descriptive name: VAY736 antibody | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan | ||
| 18 | NCT02495129 (ClinicalTrials.gov) | December 2015 | 8/7/2015 | Study of Pharmacodynamic Effects of VAY736 in Patients With Primary Sjögren's Syndrome | A Three-part, Partially Open Label and Double-blind, Randomized Study to Assess the Pharmacodynamic Effects, Safety, Tolerability and Preliminary Efficacy of VAY736 in Patients With Primary Sjögren's Syndrome Using [Zr-89]-Rituximab PET/CT | Primary Sjögren's Syndrome | Drug: VAY736 lower dose;Drug: VAY736 higher dose | Novartis Pharmaceuticals | NULL | Withdrawn | N/A | N/A | All | 0 | Phase 1/Phase 2 | Netherlands |
| 19 | NCT02149420 (ClinicalTrials.gov) | May 23, 2014 | 9/9/2013 | PD of VAY736 in Patients With Primary Sjögren's Syndrome | A Single Dose, Double-blind, Placebo-controlled, Parallel Study to Assess the Pharmacodynamics, Pharmacokinetics and Safety and Tolerability of VAY736 in Patients With Primary Sjögren's Syndrome | Primary Sjögren's Syndrome | Drug: VAY736;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 27 | Phase 2 | Germany;France;Netherlands;United States |
| 20 | EUCTR2013-000250-22-DE (EUCTR) | 11/04/2014 | 16/10/2013 | A single dose study to assess the effect of VAY736 in patients with primary Sjögren’s syndrome | A single dose, double-blind, placebo-controlled, parallel study to assess the pharmacodynamics, pharmacokinetics and safety and tolerability of VAY736 in patients with primary Sjögren’s syndrome - CVAY736X2201 | Seropositive primary Sjögren’s syndrome MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: VAY736 Other descriptive name: VAY736 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 2 | Germany |
61. 自己免疫性溶血性貧血
臨床試験数 : 146 / 薬物数 : 131 - (DrugBank : 59) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 158
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2022-001773-31-ES (EUCTR) | 14/02/2023 | 11/10/2022 | A study of efficacy and safety of ianalumab in previously treated patients with warm autoimmune haemolytic aneamia | A phase 3, randomized, double-blind, study to assess efficacy and safety of ianalumab (VAY736) versus placebo in warm autoimmune hemolytic anemia (wAIHA) patients who failed at least one line of treatment (VAYHIA) - VAYHIA | warm autoimmune haemolytic anaemia (wAIHA) MedDRA version: 25.0;Level: LLT;Classification code 10047822;Term: Warm type haemolytic anaemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Ianalumab Product Code: VAY736 INN or Proposed INN: Ianalumab | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | Argentina;Singapore;Hungary;United States;Japan;United Kingdom;Malaysia;Thailand;Spain;India;China;Taiwan;Italy;Israel;Australia;France;Germany | ||
| 2 | NCT05648968 (ClinicalTrials.gov) | December 30, 2022 | 23/11/2022 | A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia | A Phase 3, Randomized, Double-blind, Study to Assess Efficacy and Safety of Ianalumab (VAY736) Versus Placebo in Warm Autoimmune Hemolytic Anemia (wAIHA) Patients Who Failed at Least One Line of Treatment | Warm Autoimmune Hemolytic Anemia (wAIHA) | Biological: Ianalumab;Drug: Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 90 | Phase 3 | Singapore |
63. 特発性血小板減少性紫斑病
臨床試験数 : 391 / 薬物数 : 235 - (DrugBank : 50) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 139
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05653349 (ClinicalTrials.gov) | March 31, 2023 | 23/11/2022 | Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP) | A Phase III, Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (VAYHIT1) | Primary Immune Thrombocytopenia (ITP) | Biological: Ianalumab;Drug: Placebo;Drug: Corticosteroids | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 225 | Phase 3 | Belgium;Hungary;Romania;Singapore;Spain;United Kingdom |
| 2 | NCT05653219 (ClinicalTrials.gov) | February 2, 2023 | 23/11/2022 | A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids | A Phase 3 Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) Who Had an Insufficient Response or Relapsed After First Line Steroid Treatment (VAYHIT2) | Primary Immune Thrombocytopenia | Biological: Ianalumab;Drug: Eltrombopag;Drug: Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 150 | Phase 3 | Czechia;Hungary;Korea, Republic of;Singapore;United Kingdom |
| 3 | EUCTR2022-001627-32-ES (EUCTR) | 23/01/2023 | 01/11/2022 | A phase 3, randomized, double-blind, study of ianalumab (VAY736) versus placebo in addition to eltrombopag in primary immune thrombocytopenia (ITP) patients who failed steroids | A phase 3 randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to eltrombopag in patients with primary immune thrombocytopenia (ITP) who had an insufficient response or relapsed after first line steroid treatment (VAYHIT2) - VAYHIT2 | immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Ianalumab Product Code: VAY736 INN or Proposed INN: Ianalumab | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Philippines;Taiwan;Thailand;Spain;Italy;India;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Belgium;Singapore;Romania;Germany;Norway;Japan | ||
| 4 | EUCTR2022-001627-32-NL (EUCTR) | 29/12/2022 | 31/10/2022 | A phase 3, randomized, double-blind, study of ianalumab (VAY736) versus placebo in addition to eltrombopag in primary immune thrombocytopenia (ITP) patients who failed steroids | A phase 3 randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to eltrombopag in patients with primary immune thrombocytopenia (ITP) who had an insufficient response or relapsed after first line steroid treatment (VAYHIT2) - VAYHIT2 | immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Ianalumab Product Code: VAY736 INN or Proposed INN: Ianalumab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Philippines;Taiwan;Thailand;Spain;Italy;India;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Singapore;Romania;Germany;Norway;Japan | ||
| 5 | EUCTR2022-001672-34-ES (EUCTR) | 23/12/2022 | 11/10/2022 | A study of ianalumab (VAY736) in addition to first-line corticosteroids in patients with primary immune thrombocytopenia | A phase III, randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to first-line corticosteroids in primary immune thrombocytopenia (VAYHIT1) | Primary Immune thrombocytopenia (ITP);Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Ianalumab Product Code: VAY736 INN or Proposed INN: Ianalumab | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 3 | United States;Czechia;Hong Kong;Spain;Thailand;Turkey;Austria;United Kingdom;Italy;India;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Malaysia;Singapore;Romania;Viet Nam;Australia;Germany;China;Japan | ||
| 6 | EUCTR2022-001627-32-CZ (EUCTR) | 05/12/2022 | 20/10/2022 | A phase 3, randomized, double-blind, study of ianalumab (VAY736) versus placebo in addition to eltrombopag in primary immune thrombocytopenia (ITP) patients who failed steroids | A phase 3 randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to eltrombopag in patients with primary immune thrombocytopenia (ITP) who had an insufficient response or relapsed after first line steroid treatment (VAYHIT2) - VAYHIT2 | immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Ianalumab Product Code: VAY736 INN or Proposed INN: Ianalumab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Singapore;United States;Czechia;Malaysia;Thailand;Austria;Netherlands;China;Korea, Republic of;France;Romania;Hungary;Japan;Philippines;United Kingdom;India;Spain;Czech Republic;Turkey;Belgium;Norway;Taiwan;Mexico;Italy;Australia;Germany |
85. 特発性間質性肺炎
臨床試験数 : 627 / 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2017-002667-17-IT (EUCTR) | 20/09/2018 | 13/02/2018 | Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis | A subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis - Study of pharmacodynamics,pharmacokinetics, safety and tolerability of VAY736 in patients with idiop | Idiopathic pulmonary fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: VAY736 INN or Proposed INN: not established Other descriptive name: VAY736 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 2 | United States;France;Canada;Ireland;Germany;United Kingdom;Italy | ||
| 2 | EUCTR2017-002667-17-FR (EUCTR) | 06/06/2018 | 20/02/2018 | Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis | A subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis | Idiopathic pulmonary fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: VAY736 INN or Proposed INN: not established Other descriptive name: VAY736 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Canada;Ireland;Germany;Italy;United Kingdom | ||
| 3 | EUCTR2017-002667-17-DE (EUCTR) | 04/06/2018 | 23/01/2018 | Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis | A subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis | Idiopathic pulmonary fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: VAY736 INN or Proposed INN: not established Other descriptive name: VAY736 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 58 | Phase 2 | United States;France;Canada;Ireland;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2017-002667-17-GB (EUCTR) | 18/05/2018 | 08/11/2017 | Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis | A subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis | Idiopathic pulmonary fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: VAY736 INN or Proposed INN: not established Other descriptive name: VAY736 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 58 | Phase 2 | United States;France;Canada;Ireland;Germany;Italy;United Kingdom | ||
| 5 | EUCTR2017-002667-17-IE (EUCTR) | 06/04/2018 | 08/11/2017 | Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis | A subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis | Idiopathic pulmonary fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: VAY736 INN or Proposed INN: not established Other descriptive name: VAY736 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 58 | Phase 2 | United States;France;Canada;Ireland;Germany;United Kingdom;Italy | ||
| 6 | NCT03287414 (ClinicalTrials.gov) | December 20, 2017 | 12/9/2017 | Study of Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis | A Subject-, Investigator-, and Sponsor-blinded, Randomized, Placebo-controlled, Multicenter Study to Investigate Efficacy, Safety, and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: VAY736;Drug: Placebo;Drug: Standard of Care (SoC) | Novartis Pharmaceuticals | NULL | Completed | 40 Years | 80 Years | All | 30 | Phase 2 | United States;Canada;Germany;Ireland;Italy;United Kingdom;France |
95. 自己免疫性肝炎
臨床試験数 : 52 / 薬物数 : 68 - (DrugBank : 27) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 111
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2017-001555-32-DK (EUCTR) | 08/06/2018 | 08/06/2018 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER) - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: anti-BAFFR antibody | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Czech Republic;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Japan;United Kingdom;Switzerland;Sweden | ||
| 2 | EUCTR2017-001555-32-NL (EUCTR) | 26/04/2018 | 18/10/2017 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER). - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: anti-BAFFR antibody | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2;Phase 3 | United States;Czech Republic;Canada;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Switzerland;Japan;Sweden | ||
| 3 | EUCTR2017-001555-32-BE (EUCTR) | 19/03/2018 | 18/12/2017 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER). - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: anti-BAFFR antibody | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 65 | Phase 2;Phase 3 | Argentina;Singapore;United States;Czechia;Japan;United Kingdom;Switzerland;Spain;Canada;Sweden;Czech Republic;Belgium;Denmark;Germany | ||
| 4 | NCT03217422 (ClinicalTrials.gov) | February 15, 2018 | 12/7/2017 | ADCC Mediated B-Cell dEpletion and BAFF-R Blockade | A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of VAY736 in Autoimmune Hepatitis | Autoimmune Hepatitis | Biological: VAY736;Other: Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 75 Years | All | 65 | Phase 2/Phase 3 | United States;Argentina;Belgium;Canada;Czechia;Denmark;Germany;Japan;Netherlands;Singapore;Spain;Sweden;Switzerland;United Kingdom |
| 5 | EUCTR2017-001555-32-DE (EUCTR) | 01/02/2018 | 12/10/2017 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER). - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: anti-BAFFR antibody | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2;Phase 3 | United States;Czechia;Spain;United Kingdom;Switzerland;Czech Republic;Canada;Argentina;Belgium;Singapore;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 6 | EUCTR2017-001555-32-GB (EUCTR) | 16/01/2018 | 20/11/2017 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER). - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: anti-BAFFR antibody | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2;Phase 3 | United States;Spain;United Kingdom;Switzerland;Czech Republic;Canada;Argentina;Belgium;Singapore;Denmark;Netherlands;Germany;Japan;Sweden | ||
| 7 | EUCTR2017-001555-32-SE (EUCTR) | 19/12/2017 | 02/11/2017 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER). - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: anti-BAFFR antibody | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2;Phase 3 | United States;Czech Republic;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Japan;United Kingdom;Switzerland;Sweden | ||
| 8 | EUCTR2017-001555-32-ES (EUCTR) | 13/11/2017 | 11/10/2017 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER). - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.0;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: Not established Other descriptive name: anti-BAFFr antibody | Novartis Farmacéutica S.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2;Phase 3 | United States;Czech Republic;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Japan;United Kingdom;Switzerland;Sweden | ||
| 9 | EUCTR2017-001555-32-CZ (EUCTR) | 13/10/2017 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER) - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab | Novartis Pharma AG | NULL | NA | Female: yes Male: yes | 80 | Phase 2;Phase 3 | United States;Czechia;Spain;United Kingdom;Switzerland;Czech Republic;Canada;Argentina;Belgium;Singapore;Denmark;Germany;Netherlands;Japan;Sweden |