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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
5 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-004254-28-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
2EUCTR2020-000713-32-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
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
4EUCTR2019-004254-28-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
5EUCTR2020-000713-32-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