drugset / Trial / NCT03678545
Dupilumab in Eosinophilic Gastritis
Phase 2
Completed
41 enrolled
Children's Hospital Medical Center, Cincinnati
National Institute of Allergy and Infectious Diseases (NIAID) · collabRegeneron Pharmaceuticals · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
40 participants with Eosinophilic Gastritis 12-70 years of age will be randomly assigned with dupilumab or placebo subcutaneous injections every two weeks for a total of 12 weeks. Study subjects who complete the 12-week treatment phase, may continue into an open label extension study, where dupilumab will be administered every two weeks for a total of 24 weeks.
Timeline
- Start
- 2021-05-15
- Primary completion
- 2024-03-04
- Completion
- 2024-11-13
Publications
- Gonsalves NP, Dellon ES, Kliewer KL, Shoda T, Yearout R, Aceves SS, Arva NC, Besse JA, Caldwell JM, Chehade M, Coleman A, Collins MH, Anvari S, Falk GW, Gupta SK, Hiremath G, Katzka DA, Khoury P, Leung J, Menard-Katcher C, Menard-Katcher P, Peterson KA, Pletneva MA, Spergel AKR, Spergel JM, Vaysman T, Wechsler JB, Wright BL, Yang GY, Zhang X, Zhou M, Bansal A, Raphael BP, Radwan A, Maloney J, Martin A, Deniz Y, Furuta GT, Martin LJ, Rothenberg ME; Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) Investigators. Dupilumab versus placebo in adults and adolescents with eosinophilic gastritis (DEGAS): a double-blind, placebo-controlled, phase 2, multicentre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2026 Jun 23:S2468-1253(26)00116-0. doi: 10.1016/S2468-1253(26)00116-0. Online ahead of print.
- Sia T, Bacchus L, Tanaka R, Khuda R, Mallik S, Leung J. Dupilumab Can Induce Remission of Eosinophilic Gastritis and Duodenitis: A Retrospective Case Series. Clin Transl Gastroenterol. 2024 Jan 1;15(1):e00646. doi: 10.14309/ctg.0000000000000646.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dupilumab | Monoclonal antibody | 300 mg | Subcutaneous |