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
| 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 | JPRN-jRCT2031210574 | 28/07/2022 | 22/01/2022 | A 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 | A 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 | All subjects will be administered CC-93538 at a dose of 360 mg SC once weekly. | Zhang Changliang | NULL | Pending | >= 12age old | <= 75age old | Both | 22 | Phase 3 | Belgium;Australia;Argentina;Japan;United States of America;Canada;United Kingdom;Italy;Israel;Portugal;Germany;Switzerland;Poland;Spain;Austria |
| 2 | EUCTR2020-004335-24-ES (EUCTR) | 17/05/2022 | 24/03/2022 | A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 259 | Phase 3 | United States;Portugal;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan | ||
| 3 | EUCTR2020-004335-24-PL (EUCTR) | 24/03/2022 | 09/12/2021 | A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 269 | Phase 3 | Portugal;United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Poland;Belgium;Australia;Germany;Japan | ||
| 4 | JPRN-jRCT2021210067 | 04/03/2022 | 02/02/2022 | A 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 | A 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 gastroenteritis | CC-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 Changliang | NULL | Recruiting | >= 12age old | <= 75age old | Both | 45 | Phase 3 | Japan |
| 5 | NCT05214768 (ClinicalTrials.gov) | March 4, 2022 | 12/1/2022 | A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Participants With Eosinophilic Gastroenteritis | A 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 Gastroenteritis | Eosinophilic Gastroenteritis | Drug: CC-93538;Drug: Placebo | Celgene | NULL | Recruiting | 12 Years | 75 Years | All | 45 | Phase 3 | Japan |
| 6 | EUCTR2020-004335-24-PT (EUCTR) | 24/02/2022 | 03/12/2021 | A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 259 | Phase 3 | United States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan | ||
| 7 | EUCTR2020-004335-24-IT (EUCTR) | 08/02/2022 | 29/10/2021 | A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A 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 SàRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 259 | Phase 3 | United States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan | ||
| 8 | EUCTR2020-004335-24-DE (EUCTR) | 14/01/2022 | 30/07/2021 | A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 259 | Phase 3 | United States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan | ||
| 9 | EUCTR2020-004336-16-ES (EUCTR) | 12/01/2022 | 12/01/2022 | A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 399 | Phase 3 | United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand | ||
| 10 | EUCTR2020-004336-16-DE (EUCTR) | 29/09/2021 | 01/02/2021 | A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 399 | Phase 3 | United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand | ||
| 11 | EUCTR2020-004336-16-PT (EUCTR) | 24/09/2021 | 01/04/2021 | A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 399 | Phase 3 | United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand | ||
| 12 | NCT04991935 (ClinicalTrials.gov) | September 14, 2021 | 28/7/2021 | Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis | A 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 | Drug: CC-93538 | Celgene | NULL | Recruiting | 12 Years | 75 Years | All | 259 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Germany;Israel;Italy;Japan;Poland;Portugal;Spain;Switzerland;United Kingdom |
| 13 | EUCTR2020-004336-16-AT (EUCTR) | 01/08/2021 | 22/03/2021 | A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 399 | Phase 3 | Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand;United Kingdom;United States;Portugal;Czechia;Spain;Austria;Israel | ||
| 14 | EUCTR2020-004336-16-PL (EUCTR) | 21/07/2021 | 12/05/2021 | A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 399 | Phase 3 | Portugal;United States;Czechia;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand | ||
| 15 | JPRN-jRCT2051200140 | 01/07/2021 | 19/02/2021 | A 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 | A 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 | CC-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 Changliang | NULL | Recruiting | >= 12age old | <= 75age old | Both | 33 | Phase 3 | United States of America;Canada;UK;Italy;Israel;Portugal;Germany;Switzerland;Poland;Spain;Austria;Belgium;Australia;Argentina;Japan |
| 16 | EUCTR2020-004336-16-IT (EUCTR) | 17/06/2021 | 08/06/2021 | A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A 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 SàRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 399 | Phase 3 | United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand | ||
| 17 | NCT04753697 (ClinicalTrials.gov) | February 22, 2021 | 5/2/2021 | A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis | A 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 Esophagitis | Drug: CC-93538;Other: Placebo | Celgene | NULL | Recruiting | 12 Years | 75 Years | All | 399 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Germany;Israel;Italy;Japan;Poland;Portugal;Spain;Switzerland;United Kingdom;Puerto Rico |
| 18 | EUCTR2020-004335-24-AT (EUCTR) | 18/11/2021 | A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A 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 Sàrl | NULL | NA | Female: yes Male: yes | 259 | Phase 3 | United States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan | |||
| 19 | EUCTR2020-004336-16-BE (EUCTR) | 07/05/2021 | A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A 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 Sàrl | NULL | NA | Female: yes Male: yes | 399 | Phase 3 | United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand | |||
| 20 | EUCTR2020-004335-24-BE (EUCTR) | 24/12/2021 | A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A 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 Sàrl | NULL | NA | Female: yes Male: yes | 259 | Phase 3 | Portugal;Spain;Austria;Israel;United Kingdom;Italy;United States;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan |