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 | NCT04856891 (ClinicalTrials.gov) | May 20, 2021 | 20/4/2021 | A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Patients With Moderately to Severely Active Eosinophilic Duodenitis Who Have an Inadequate Response With, Lost Response to, or Were Intolerant to Standard Therapies | Eosinophilic Duodenitis;Eosinophilic Gastroenteritis | Drug: AK002;Other: Placebo | Allakos, Inc. | NULL | Active, not recruiting | 18 Years | 80 Years | All | 94 | Phase 3 | United States |
| 2 | NCT04620811 (ClinicalTrials.gov) | December 3, 2020 | 3/11/2020 | An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis) | A Phase 3, Multicenter, Open-Label, Extension Study to Evaluate the Efficacy and Safety of AK002 in Patients That Were Previously Enrolled in AK002-016 or AK002-012 Studies and Have Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis) | Eosinophilic Gastritis;Eosinophilic Duodenitis | Drug: lirentelimab | Allakos, Inc. | NULL | Enrolling by invitation | 18 Years | 80 Years | All | 170 | Phase 3 | United States |
| 3 | EUCTR2019-004391-19-NL (EUCTR) | 30/07/2020 | 13/05/2020 | Study to Evaluate the Efficacy and Safety of AK002 in Subjects with Active Eosinophilic Esophagitis | A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safetyof AK002 in Adult and Adolescent Subjects with Active Eosinophilic Esophagitis | Active Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: AK002 INN or Proposed INN: not available | Allakos Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2;Phase 3 | United States;Australia;Netherlands | ||
| 4 | NCT04322708 (ClinicalTrials.gov) | July 6, 2020 | 24/3/2020 | A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis | A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lirentelimab (AK002) in Adult and Adolescent Patients With Active Eosinophilic Esophagitis | Eosinophilic Esophagitis | Other: Placebo;Drug: lirentelimab (AK002) | Allakos, Inc. | NULL | Active, not recruiting | 12 Years | 80 Years | All | 277 | Phase 2/Phase 3 | United States;Australia;Netherlands |
| 5 | NCT04322604 (ClinicalTrials.gov) | June 18, 2020 | 24/3/2020 | A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AK002 in Patients With Moderately to Severely Active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis) | Eosinophilic Gastritis;Eosinophilic Duodenitis | Drug: lirentelimab (AK002);Other: Placebo | Allakos, Inc. | NULL | Active, not recruiting | 18 Years | 80 Years | All | 180 | Phase 3 | United States |
| 6 | NCT03664960 (ClinicalTrials.gov) | November 14, 2018 | 6/9/2018 | An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis | A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Safety and Tolerability of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis) | Eosinophilic Gastritis;Eosinophilic Gastroenteritis;Eosinophilic Duodenitis | Drug: AK002 | Allakos, Inc. | NULL | Active, not recruiting | 18 Years | 80 Years | All | 58 | Phase 2 | United States |
| 7 | NCT03496571 (ClinicalTrials.gov) | July 18, 2018 | 6/4/2018 | A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamic Effect of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis | Eosinophilic Gastritis;Eosinophilic Gastroenteritis | Drug: AK002;Other: Placebo | Allakos, Inc. | NULL | Completed | 18 Years | 80 Years | All | 65 | Phase 2 | United States |