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8

28. 全身性アミロイドーシス [臨床試験数:212,薬物数:234(DrugBank:72),標的遺伝子数:54,標的パスウェイ数:170
Searched query = "Systemic amyloidosis", "AL amyloidosis", "Immunoglobulin light chain amyloidosis", "Amyloid light-chain amyloidosis", "Familial amyloidosis", "Familial amyloid polyneuropathy", "Senile transthyretin amyloidosis", "Senile TTR amyloidosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
8 / 212 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-000713-32-DE
(EUCTR)
23/12/202009/09/2020A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
267Phase 3United States;Greece;Spain;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany;Japan
2EUCTR2019-004254-28-DE
(EUCTR)
23/12/202009/09/2020A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
111Phase 3United States;Greece;Spain;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany;Japan
3EUCTR2019-004254-28-GB
(EUCTR)
30/11/202010/09/2020A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
111Phase 3United States;Greece;Spain;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Germany;Japan
4EUCTR2020-000713-32-GR
(EUCTR)
27/11/202005/10/2020A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
267Phase 3United States;Greece;Spain;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany;Japan
5EUCTR2019-004254-28-GR
(EUCTR)
27/11/202005/10/2020A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
111Phase 3United States;Greece;Spain;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04504825
(ClinicalTrials.gov)
August 25, 202020/7/2020A Study to Evaluate the Effectiveness and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL AmyloidosisA 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 AmyloidosisAL AmyloidosisDrug: CAEL-101;Other: Placebo;Drug: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD)Caelum BiosciencesIQVIA BiotechRecruiting18 YearsN/AAll111Phase 3United States;Australia;Belgium;Canada;France;Germany;Greece;Israel;Italy;Japan;Poland;Russian Federation;Spain;United Kingdom
7NCT04512235
(ClinicalTrials.gov)
August 25, 202010/8/2020A Study to Evaluate the Effectiveness and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL AmyloidosisA 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 AmyloidosisAL AmyloidosisDrug: CAEL-101;Other: Placebo;Drug: cyclophosphamide, bortezomib, and dexamethasone (CyBorD)Caelum BiosciencesIQVIA BiotechRecruiting18 YearsN/AAll267Phase 3United States;Australia;Belgium;Canada;France;Germany;Greece;Israel;Italy;Japan;Poland;Russian Federation;Spain;United Kingdom
8NCT04304144
(ClinicalTrials.gov)
March 18, 202028/2/2020A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL AmyloidosisCAEL101-203: A Phase 2, Open-label, Multicenter Dose Selection Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL AmyloidosisAL AmyloidosisDrug: CAEL-101Caelum BiosciencesNULLEnrolling by invitation18 YearsN/AAll25Phase 2United States