98. 好酸球性消化管疾患 Eosinophilic gastrointestinal disease Clinical trials / Disease details


臨床試験数 : 172 薬物数 : 149 - (DrugBank : 39) / 標的遺伝子数 : 38 - 標的パスウェイ数 : 135

  
20 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1JPRN-jRCT2031210574
28/07/202222/01/2022A PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH 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 esophagitisAll subjects will be administered CC-93538 at a dose of
360 mg SC once weekly.
Zhang ChangliangNULLPending>= 12age old<= 75age oldBoth22Phase 3Belgium;Australia;Argentina;Japan;United States of America;Canada;United Kingdom;Italy;Israel;Portugal;Germany;Switzerland;Poland;Spain;Austria
2EUCTR2020-004335-24-ES
(EUCTR)
17/05/202224/03/2022A 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;Switzerland;United Kingdom;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan
3EUCTR2020-004335-24-PL
(EUCTR)
24/03/202209/12/2021A 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
269Phase 3Portugal;United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Poland;Belgium;Australia;Germany;Japan
4JPRN-jRCT2021210067
04/03/202202/02/2022A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO-CONTROLLED INDUCTION AND MAINTENANCE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-93538 IN ADULT AND ADOLESCENT JAPANESE SUBJECTS WITH EOSINOPHILIC GASTROENTERITISA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO-CONTROLLED INDUCTION AND MAINTENANCE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-93538 IN ADULT AND ADOLESCENT JAPANESE SUBJECTS WITH EOSINOPHILIC GASTROENTERITIS Eosinophilic gastroenteritisCC-93538 is administered subcutaneously at a dose of 360 mg weekly in adults and adolescents of 12 years of age or older.After 16 weeks after the initial administration,a dose of 360 mg is administered subcutaneously weekly or bi-weekly.During the OLE phase,360 mg will be administered subcutaneously weekly.Zhang ChangliangNULLRecruiting>= 12age old<= 75age oldBoth45Phase 3Japan
5NCT05214768
(ClinicalTrials.gov)
March 4, 202212/1/2022A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Participants With Eosinophilic GastroenteritisA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Subjects With Eosinophilic GastroenteritisEosinophilic GastroenteritisDrug: CC-93538;Drug: PlaceboCelgeneNULLRecruiting12 Years75 YearsAll45Phase 3Japan
6EUCTR2020-004335-24-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
7EUCTR2020-004335-24-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
8EUCTR2020-004335-24-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
9EUCTR2020-004336-16-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
10EUCTR2020-004336-16-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
11EUCTR2020-004336-16-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
12NCT04991935
(ClinicalTrials.gov)
September 14, 202128/7/2021Safety Study of CC-93538 in Adult and Adolescent Participants With 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 EsophagitisEosinophilic EsophagitisDrug: CC-93538CelgeneNULLRecruiting12 Years75 YearsAll259Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;Germany;Israel;Italy;Japan;Poland;Portugal;Spain;Switzerland;United Kingdom
13EUCTR2020-004336-16-AT
(EUCTR)
01/08/202122/03/2021A 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 SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
399Phase 3Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand;United Kingdom;United States;Portugal;Czechia;Spain;Austria;Israel
14EUCTR2020-004336-16-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 3Portugal;United States;Czechia;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand
15JPRN-jRCT2051200140
01/07/202119/02/2021A 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 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 esophagitisCC-93538 is administered subcutaneously at a dose of 360 mg weekly in adults and adolescent 12 years of age or older. After 24 weeks after the initial dose, a dose of 360 mg is administered subcutaneously weekly or biweekly.Zhang ChangliangNULLRecruiting>= 12age old<= 75age oldBoth33Phase 3United States of America;Canada;UK;Italy;Israel;Portugal;Germany;Switzerland;Poland;Spain;Austria;Belgium;Australia;Argentina;Japan
16EUCTR2020-004336-16-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
17NCT04753697
(ClinicalTrials.gov)
February 22, 20215/2/2021A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic EsophagitisA Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Long-term Controlled Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects With Active Eosinophilic Esophagitis.Eosinophilic EsophagitisDrug: CC-93538;Other: PlaceboCelgeneNULLRecruiting12 Years75 YearsAll399Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;Germany;Israel;Italy;Japan;Poland;Portugal;Spain;Switzerland;United Kingdom;Puerto Rico
18EUCTR2020-004335-24-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
19EUCTR2020-004336-16-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
20EUCTR2020-004335-24-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