28. 全身性アミロイドーシス Systemic amyloidosis Clinical trials / Disease details
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
| 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 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 | 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] | 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 | ||
| 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 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 | 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] | 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 | ||
| 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 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 | 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] | 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 | ||
| 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 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 | 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] | 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 | ||
| 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 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 | 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] | 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 | ||
| 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 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 | AL Amyloidosis | 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 |
| 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 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 | 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] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: CHIMERIC FIBRIL-REACTIVE IGG1K MONOCLONAL ANTIBODY 11-1F4 | 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 | ||
| 8 | 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, 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 | 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. | 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 |
| 9 | 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, 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 | 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. | 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 |
| 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 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 | 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] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: CHIMERIC FIBRIL-REACTIVE IGG1K MONOCLONAL ANTIBODY 11-1F4 | 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 | ||
| 11 | EUCTR2019-004254-28-BE (EUCTR) | 04/01/2021 | 05/11/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | 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 | 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] | 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;Greece;Spain;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Germany;Japan | ||
| 12 | EUCTR2019-004254-28-DE (EUCTR) | 23/12/2020 | 09/09/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | 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 | 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] | 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 | 124 | 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 | ||
| 13 | EUCTR2020-000713-32-DE (EUCTR) | 23/12/2020 | 09/09/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | 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 | 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] | 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 | 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 | ||
| 14 | EUCTR2019-004254-28-GB (EUCTR) | 30/11/2020 | 10/09/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | 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 | 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] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: CHIMERIC FIBRIL-REACTIVE IGG1K MONOCLONAL ANTIBODY 11-1F4 | 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;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Germany;Japan | ||
| 15 | EUCTR2019-004254-28-GR (EUCTR) | 27/11/2020 | 05/10/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | 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 | 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] | 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;Greece;Spain;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany;Japan | ||
| 16 | EUCTR2020-000713-32-GR (EUCTR) | 27/11/2020 | 05/10/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | 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 | 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] | 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 | 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 | ||
| 17 | NCT04512235 (ClinicalTrials.gov) | November 12, 2020 | 10/8/2020 | A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis | 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 | AL Amyloidosis | Drug: CAEL-101;Other: Placebo;Drug: cyclophosphamide, bortezomib, and dexamethasone (CyBorD) regimen | Alexion | NULL | Recruiting | 18 Years | N/A | All | 267 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;United Kingdom |
| 18 | NCT04304144 (ClinicalTrials.gov) | March 18, 2020 | 28/2/2020 | A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis | CAEL101-203: A Phase 2, Open-label, Multicenter Dose Selection Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis | AL Amyloidosis | Drug: CAEL-101;Drug: SoC: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD);Drug: Daratumumab | Alexion Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 25 | Phase 2 | United States |