Nipocalimab ( DrugBank: Nipocalimab )
5 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 11 | 重症筋無力症 | 9 |
| 46 | 悪性関節リウマチ | 3 |
| 49 | 全身性エリテマトーデス | 5 |
| 53 | シェーグレン症候群 | 7 |
| 61 | 自己免疫性溶血性貧血 | 7 |
11. 重症筋無力症
臨床試験数 : 315 / 薬物数 : 232 - (DrugBank : 77) / 標的遺伝子数 : 46 - 標的パスウェイ数 : 126
| 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 | NCT05265273 (ClinicalTrials.gov) | March 31, 2022 | 22/2/2022 | A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis | An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis | Myasthenia Gravis | Drug: Nipocalimab | Janssen Research & Development, LLC | NULL | Not yet recruiting | 2 Years | 17 Years | All | 12 | Phase 2/Phase 3 | United States;Canada;Japan;Netherlands |
| 2 | JPRN-jRCT2021210027 | 20/01/2022 | 13/08/2021 | A Study of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Myasthenia Gravis | Nipocalimab (JNJ-80202135, M281) Double-blind Placebo-controlled Phase: Participants will receive nipocalimab intravenous (IV) infusions once every 2 weeks (q2w) up to 24 weeks during double-blind placebo-controlled phase. Open-label Extension (OLE) Phase: Participants who complete the double-blind placebo-controlled phase will enter the OLE phase and continue to receive nipocalimab q2w IV infusion from OLE Day 1 to 24 weeks. Participants who are stable on the q2w dosing regimen can be transitioned to a dosing regimen every 4 weeks (q4w) during OLE phase Placebo Double-blind Placebo-controlled Phase: Participants will receive matching placebo of nipocalimab IV infusion q2w up to 24 weeks during double-blind placebo-controlled phase. | Nakano Masayoshi | NULL | Pending | >= 18age old | Not applicable | Both | 180 | Phase 3 | Belgium;Canada;China;Colombia;Czechia;Germany;Denmark;Spain;France;Kingdom Of Great Britain And Northern Ireland;Italy;Mexico;Poland;Russian Federation;Sweden;Turkey;United States Of America;Japan |
| 3 | EUCTR2020-005732-29-DK (EUCTR) | 13/01/2022 | 25/06/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Myasthenia gravis (MG). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 4 | EUCTR2020-005732-29-DE (EUCTR) | 19/11/2021 | 23/06/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Myasthenia gravis (MG). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 5 | EUCTR2020-005732-29-SE (EUCTR) | 03/11/2021 | 24/06/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Myasthenia gravis (MG). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 6 | EUCTR2020-005732-29-CZ (EUCTR) | 21/10/2021 | 15/07/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Myasthenia gravis (MG). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 7 | EUCTR2020-005732-29-ES (EUCTR) | 03/09/2021 | 26/08/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Myasthenia gravis (MG). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 8 | EUCTR2020-005732-29-IT (EUCTR) | 20/08/2021 | 12/10/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis - N/A | Myasthenia gravis (MG);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Nipocalimab Product Code: [JNJ-80202135] INN or Proposed INN: Nipocalimab Other descriptive name: M281 | JANSSEN CILAG INTERNATIONAL NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 9 | NCT04951622 (ClinicalTrials.gov) | July 15, 2021 | 30/6/2021 | A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis | Myasthenia Gravis | Drug: Nipocalimab;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | N/A | All | 180 | Phase 3 | United States;Australia;Belgium;Canada;China;Colombia;Czechia;Denmark;France;Germany;Italy;Japan;Korea, Republic of;Mexico;Poland;Russian Federation;Spain;Sweden;Taiwan;Turkey;United Kingdom |
46. 悪性関節リウマチ
臨床試験数 : 4,325 / 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
| 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 | NCT04991753 (ClinicalTrials.gov) | October 14, 2021 | 2/8/2021 | A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants With Active Rheumatoid Arthritis Despite Standard Therapy | Arthritis, Rheumatoid | Other: Placebo;Drug: Nipocalimab | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 75 Years | All | 50 | Phase 2 | United States;Germany;Poland;Spain;United Kingdom |
| 2 | EUCTR2021-000510-42-DE (EUCTR) | 05/10/2021 | 16/07/2021 | A Proof-of-concept Study of the Efficacy and Safety of Nipocalimabin Participants with Active Rheumatoid Arthritis. | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants with Active Rheumatoid Arthritis Despite Standard Therapy. | Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | United States;Spain;Poland;Germany;United Kingdom | ||
| 3 | EUCTR2021-000510-42-ES (EUCTR) | 17/09/2021 | 09/07/2021 | A Proof-of-concept Study of the Efficacy and Safety of Nipocalimabin Participants with Active Rheumatoid Arthritis. | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants with Active Rheumatoid Arthritis Despite Standard Therapy. - IRIS | Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | United States;Poland;Spain;Germany;United Kingdom |
49. 全身性エリテマトーデス
臨床試験数 : 946 / 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199
| 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 | JPRN-jRCT2041210058 | 04/02/2022 | 20/08/2021 | A Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Group 1_Placebo:Participants will receive placebo intravenously (IV) every two weeks (q2w) through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and Glucocorticoids [GCs]). Group 2_Nipocalimab Dose 1: Participants will receive nipocalimab dose 1 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs). Group 3_Nipocalimab Dose 2: Participants will receive nipocalimab dose 2 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs). | Numaguchi Hirotaka | NULL | Recruiting | >= 18age old | <= 65age old | Both | 225 | Phase 2 | Bulgaria;Colombia;Germany;Spain;Hungary;Poland;Taiwan, Province Of China;Ukraine;United States OfAmerica;South Africa;Japan |
| 2 | EUCTR2020-005569-14-BG (EUCTR) | 12/11/2021 | 29/09/2021 | A Clinical Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | Active 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: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 2 | United States;Hong Kong;Taiwan;Spain;Ukraine;Russian Federation;Colombia;Hungary;Argentina;Poland;Bulgaria;South Africa;Germany;Japan | ||
| 3 | EUCTR2020-005569-14-HU (EUCTR) | 24/08/2021 | 09/07/2021 | A Clinical Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | Active 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: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 2 | United States;Hong Kong;Taiwan;Spain;Ukraine;Russian Federation;Colombia;Hungary;Argentina;Poland;South Africa;Bulgaria;Germany;Japan | ||
| 4 | NCT04882878 (ClinicalTrials.gov) | August 20, 2021 | 7/5/2021 | A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Other: Placebo;Drug: Nipocalimab;Drug: Standard-of-care treatment | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 65 Years | All | 225 | Phase 2 | United States;Argentina;Bulgaria;Colombia;Germany;Hungary;Japan;Poland;Russian Federation;South Africa;Spain;Taiwan;Ukraine;Hong Kong |
| 5 | EUCTR2020-005569-14-ES (EUCTR) | 13/08/2021 | 13/08/2021 | A Clinical Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | Active 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: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 2 | United States;Hong Kong;Taiwan;Spain;Ukraine;Russian Federation;Colombia;Hungary;Argentina;Poland;South Africa;Bulgaria;Germany;Japan |
53. シェーグレン症候群
臨床試験数 : 283 / 薬物数 : 320 - (DrugBank : 101) / 標的遺伝子数 : 56 - 標的パスウェイ数 : 181
| 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 | JPRN-jRCT2031210484 | 28/02/2022 | 14/12/2021 | A Study of Nipocalimab in Adults with Primary Sjogren'sSyndrome (pSS) | A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome(pSS) | Sjogren's Syndrome | Placebo Placebo infusion will be administered intravenously. Nipocalimab Nipocalimab dose 1 and dose 2 infusions will be administered intravenously. Standard of Care Treatment Standard of care treatment including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues, and/or one immunomodulator with or without low-dose glucocorticosteroids will be administered topically/orally. | Numaguchi Hirotaka | NULL | Pending | >= 18age old | <= 65age old | Both | 150 | Phase 2 | Germany;Spain;Italy;Netherlands;Poland;Portugal;United States Of America;France;Taiwan;Japan |
| 2 | EUCTR2021-000665-32-NL (EUCTR) | 16/02/2022 | 21/10/2021 | A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Primary Sjogren's Syndrome MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: nipocalimab Other descriptive name: JNJ-80202135 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Portugal;France;United States;Taiwan;Spain;Poland;Germany;Netherlands;Italy;Japan | ||
| 3 | EUCTR2021-000665-32-DE (EUCTR) | 12/11/2021 | 27/07/2021 | A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Primary Sjogren's Syndrome MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: nipocalimab Other descriptive name: JNJ-80202135 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Portugal;France;United States;Taiwan;Spain;Poland;Netherlands;Germany;Italy;Japan | ||
| 4 | EUCTR2021-000665-32-IT (EUCTR) | 10/11/2021 | 08/09/2021 | A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) - NA | Primary Sjogren's Syndrome MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: nipocalimab Product Code: [M281] INN or Proposed INN: nipocalimab Other descriptive name: JNJ-80202135 | JANSSEN CILAG INTERNATIONAL NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Portugal;France;United States;Taiwan;Spain;Poland;Netherlands;Germany;Japan;Italy | ||
| 5 | EUCTR2021-000665-32-PT (EUCTR) | 09/11/2021 | 16/09/2021 | A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Primary Sjogren's Syndrome MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: nipocalimab Other descriptive name: JNJ-80202135 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | France;United States;Portugal;Taiwan;Spain;Poland;Netherlands;Germany;Italy;Japan | ||
| 6 | EUCTR2021-000665-32-ES (EUCTR) | 26/10/2021 | 27/08/2021 | A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS). | Primary Sjogren's Syndrome MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: nipocalimab Other descriptive name: JNJ-80202135 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Portugal;France;United States;Taiwan;Poland;Spain;Netherlands;Germany;Italy;Japan | ||
| 7 | NCT04968912 (ClinicalTrials.gov) | September 21, 2021 | 9/7/2021 | A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS) | A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS) | Sjogren's Syndrome | Other: Placebo;Drug: Nipocalimab;Drug: Standard of Care Treatment | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 75 Years | All | 150 | Phase 2 | United States;France;Germany;Italy;Japan;Netherlands;Poland;Portugal;Spain;Taiwan |
61. 自己免疫性溶血性貧血
臨床試験数 : 137 / 薬物数 : 127 - (DrugBank : 55) / 標的遺伝子数 : 26 - 標的パスウェイ数 : 153
| 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 | NCT05221619 (ClinicalTrials.gov) | February 10, 2022 | 5/1/2022 | Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA) | Nipocalimab Post-trial Access in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA) Who Are Experiencing Clinical Benefit After Complete 28-Weeks Open-label Extension in MOM-M281-006 | Anemia, Hemolytic, Autoimmune | Drug: Nipocalimab | Janssen Research & Development, LLC | NULL | Available | N/A | N/A | All | NULL | ||
| 2 | EUCTR2019-000720-17-NL (EUCTR) | 31/03/2020 | 16/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Netherlands;Germany | ||
| 3 | EUCTR2019-000720-17-DE (EUCTR) | 14/01/2020 | 05/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 4 | EUCTR2019-000720-17-GR (EUCTR) | 27/12/2019 | 08/10/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 148 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 5 | EUCTR2019-000720-17-HU (EUCTR) | 05/11/2019 | 06/11/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10073784;Term: Anemia hemolytic autoimmune;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 6 | EUCTR2019-000720-17-PL (EUCTR) | 09/10/2019 | 27/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: Not Applicable Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 7 | EUCTR2019-000720-17-CZ (EUCTR) | 10/09/2019 | 10/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 2;Phase 3 | Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands;United States;Czechia;Greece;Spain |