CAEL-101 ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 28 | 全身性アミロイドーシス | 18 |
28. 全身性アミロイドーシス
臨床試験数 : 267 / 薬物数 : 241 - (DrugBank : 77) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 180
Showing 1 to 10 of 18 diseases
| 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 | EUCTR2020-000713-32-CZ (EUCTR) | 19/09/2022 | 07/02/2022 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. A double-blind study to evaluate the effectiveness and safety of CAEL-101in patients with AL amyloid ... | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101and Plasma ... | stage IIIa cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] stage IIIa cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: ... | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) ... | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 267 | Phase 3 | Russian Federation;United States;Czechia;Japan;Korea, Democratic People's Republic of;United Kingdom;Switzerland;Spain;Greece;Canada;Czech Republic;Austria;Netherlands;Belgium;Brazil;Poland;Italy;Israel;Australia;France;Germany Russian Federation;United States;Czechia;Japan;Korea, Democratic People's Republic of;United Kingdom ... | ||
| 2 | EUCTR2019-004254-28-AT (EUCTR) | 24/01/2022 | 16/07/2021 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. A double-blind study to evaluate the effectiveness and safety of CAEL-101in patients with AL amyloid ... | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101and Plasma ... | stage IIIb cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] stage IIIb cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: ... | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) ... | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 111 | Phase 3 | United States;Czechia;Greece;Spain;Korea, Democratic People's Republic of;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Brazil;Australia;Netherlands;Germany;Japan United States;Czechia;Greece;Spain;Korea, Democratic People's Republic of;Austria;Russian Federation ... | ||
| 3 | EUCTR2020-000713-32-AT (EUCTR) | 24/01/2022 | 16/07/2021 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. A double-blind study to evaluate the effectiveness and safety of CAEL-101in patients with AL amyloid ... | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101and Plasma ... | stage IIIa cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] stage IIIa cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: ... | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) ... | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 267 | Phase 3 | United States;Czechia;Greece;Spain;Korea, Democratic People's Republic of;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Brazil;Poland;Australia;Germany;Netherlands;Japan United States;Czechia;Greece;Spain;Korea, Democratic People's Republic of;Austria;Russian Federation ... | ||
| 4 | EUCTR2019-004254-28-PL (EUCTR) | 23/02/2021 | 22/10/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. A double-blind study to evaluate the effectiveness and safety of CAEL-101in patients with AL amyloid ... | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101and Plasma ... | stage IIIb cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] stage IIIb cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: ... | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) ... | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 111 | Phase 3 | Canada;Poland;Belgium;United States;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Australia;Germany;Japan Canada;Poland;Belgium;United States;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;It ... | ||
| 5 | EUCTR2020-000713-32-PL (EUCTR) | 17/02/2021 | 19/10/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. A double-blind study to evaluate the effectiveness and safety of CAEL-101in patients with AL amyloid ... | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101and Plasma ... | stage IIIa cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] stage IIIa cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: ... | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) ... | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 267 | Phase 3 | United States;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Germany;Japan United States;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Pola ... | ||
| 6 | NCT04504825 (ClinicalTrials.gov) | February 2, 2021 | 20/7/2020 | A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis A Study to Evaluate the Efficacy and Safety of CAEL-101in Patients With Mayo Stage IIIb AL Amyloidos ... | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIb AL Amyloidosis A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101and Plasma ... | AL Amyloidosis | Drug: CAEL-101;Other: Placebo;Drug: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) regimen Drug: CAEL-101;Other: Placebo;Drug: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) regimen ... | Alexion | NULL | Recruiting | 18 Years | N/A | All | 124 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;Switzerland;United Kingdom United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;France;Germany;Greece;Israel;Italy;Jap ... |
| 7 | EUCTR2020-000713-32-BE (EUCTR) | 18/01/2021 | 09/11/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. A double-blind study to evaluate the effectiveness and safety of CAEL-101in patients with AL amyloid ... | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101and Plasma ... | stage IIIa cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] stage IIIa cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: ... | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: CHIMERIC FIBRIL-REACTIVE IGG1K MONOCLONAL ANTIBODY 11-1F4 Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: CHIMERIC FIBRIL-REACT ... | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 267 | Phase 3 | United States;Greece;Spain;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Germany;Japan United States;Greece;Spain;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Pola ... | ||
| 8 | JPRN-jRCT2031200300 | 15/01/2021 | 15/01/2021 | A Phase 3 Study to Evaluate the Efficacy and Safety of CAEL-101 in Plasma Cell Dyscrasia Treatment Naive Patients with Mayo Stage IIIa AL Amyloidosis A Phase 3 Study to Evaluate the Efficacy and Safety of CAEL-101in Plasma Cell Dyscrasia Treatment Na ... | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naive Patients with Mayo Stage IIIa AL Amyloidosis A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101and Plasma ... | AL Amyloidosis | This is a double-blind, randomized, multicenter international Phase 3 study of CAEL-101 combined with the SoC treatment for plasma cell dyscrasia (PCD) versus placebo combined with standard of care PCD treatment in patients with Mayo stage IIIa AL amyloidosis that have not received prior treatment. Patients randomized to receive CAEL-101 will receive 1000 mg/m2. CAEL-101 is administered as an intravenous (IV) infusion over approximately 2 hours. The minimum planned treatment time for each patient will be at least 50 weeks or until the patient's death. It is planned that all patients will continue their double-blind treatment until the last patient completes at least 50 weeks of treatment. Approximately 267 patients will be enrolled using a 2:1 randomization ratio. A sample size re-estimation (SSR) procedure will be performed when approximately 40% of the expected deaths has been observed. Patients in both treatment groups will be followed from randomization until death from any cause or until the end of study. This is a double-blind, randomized, multicenter international Phase 3 study of CAEL-101combined with ... | Caelum Medical Monitor | NULL | Recruiting | >= 18age old | Not applicable | Both | 9 | Phase 3 | US;UK;Australia;Canada;France;Spain;Italy;Israel;Germany;Poland;Greece;Belgium;Russia;Japan |
| 9 | JPRN-jRCT2031200299 | 15/01/2021 | 15/01/2021 | A Phase 3 Study to Evaluate the Efficacy and Safety of CAEL-101 in Plasma Cell Dyscrasia Treatment Naive Patients with Mayo Stage IIIb AL Amyloidosis A Phase 3 Study to Evaluate the Efficacy and Safety of CAEL-101in Plasma Cell Dyscrasia Treatment Na ... | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naive Patients with Mayo Stage IIIb AL Amyloidosis A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101and Plasma ... | AL Amyloidosis | This is a double-blind, randomized, multicenter international Phase 3 study of CAEL-101 combined with the SoC treatment for plasma cell dyscrasia (PCD) versus placebo combined with standard of care PCD treatment in patients with Mayo stage IIIb AL amyloidosis that have not received prior treatment. Patients randomized to receive CAEL-101 will receive 1000 mg/m2. CAEL-101 is administered as an intravenous (IV) infusion over approximately 2 hours. The minimum planned treatment time for each patient will be at least 50 weeks or until the patient's death. It is planned that all patients will continue their double-blind treatment until the last patient completes at least 50 weeks of treatment. Approximately 111 patients will be enrolled using a 2:1 randomization ratio. A sample size re-estimation (SSR) procedure will be performed when approximately 50% of the expected deaths has been observed. Patients in both treatment groups will be followed from randomization until death from any cause or until the end of study. This is a double-blind, randomized, multicenter international Phase 3 study of CAEL-101combined with ... | Caelum Medical Monitor | NULL | Recruiting | >= 18age old | Not applicable | Both | 3 | Phase 3 | US;UK;Australia;Canada;France;Spain;Italy;Israel;Germany;Poland;Greece;Belgium;Russia;Japan |
| 10 | EUCTR2019-004254-28-FR (EUCTR) | 07/01/2021 | 04/09/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. A double-blind study to evaluate the effectiveness and safety of CAEL-101in patients with AL amyloid ... | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101and Plasma ... | stage IIIb cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] stage IIIb cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: ... | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: CHIMERIC FIBRIL-REACTIVE IGG1K MONOCLONAL ANTIBODY 11-1F4 Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: CHIMERIC FIBRIL-REACT ... | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 111 | Phase 3 | United States;Greece;Spain;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany;Japan United States;Greece;Spain;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Pola ... |