Cendakimab ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
98好酸球性消化管疾患12

98. 好酸球性消化管疾患


臨床試験数 : 171 薬物数 : 184 - (DrugBank : 47) / 標的遺伝子数 : 42 - 標的パスウェイ数 : 141
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-004335-24-PT
(EUCTR)
24/02/202203/12/2021A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
259Phase 3United States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan
2EUCTR2020-004335-24-IT
(EUCTR)
08/02/202229/10/2021A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA Phase 3, Multicenter, Multinational, Open-Label Extension Study to evaluate the Long-Term Safety of CC-93538 in adult and adolescent subjects with Eosinophilic Esophagitis - - EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Trade Name: Cendakimab
Product Name: Cendakimab
Product Code: [CC-93538]
INN or Proposed INN: Cendakimab
CELGENE INTERNATIONAL II SàRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
259Phase 3United States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan
3EUCTR2020-004335-24-DE
(EUCTR)
14/01/202230/07/2021A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
259Phase 3United States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan
4EUCTR2020-004336-16-ES
(EUCTR)
12/01/202212/01/2022A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
399Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand
5EUCTR2020-004336-16-DE
(EUCTR)
29/09/202101/02/2021A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
399Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand
6EUCTR2020-004336-16-PT
(EUCTR)
24/09/202101/04/2021A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
399Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand
7EUCTR2020-004336-16-PL
(EUCTR)
21/07/202112/05/2021A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
399Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Poland;Belgium;Australia;Germany;Japan;New Zealand
8EUCTR2020-004336-16-IT
(EUCTR)
17/06/202108/06/2021A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC-93538 in adult and adolescent subjects with eosinophilic esophagitis - - EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: [CC-93538]
INN or Proposed INN: Cendakimab
CELGENE INTERNATIONAL II SàRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
399Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand
9EUCTR2020-004336-16-BE
(EUCTR)
07/05/2021A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLNAFemale: yes
Male: yes
399Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand
10EUCTR2020-004336-16-AT
(EUCTR)
22/03/2021A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLNAFemale: yes
Male: yes
399Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand
11EUCTR2020-004335-24-AT
(EUCTR)
18/11/2021A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLNAFemale: yes
Male: yes
259Phase 3United States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan
12EUCTR2020-004335-24-BE
(EUCTR)
24/12/2021A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLNAFemale: yes
Male: yes
259Phase 3Portugal;Spain;Austria;Israel;United Kingdom;Italy;United States;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan