An international consensus on the design of clinical trials for advanced combination treatment (ACT) in inflammatory bowel disease.

Fiche publication

Date publication

novembre 2025

Journal

EClinicalMedicine

Auteurs

Membres identifiés du Cancéropôle Est :
Pr PEYRIN-BIROULET Laurent

Tous les auteurs :
Solitano V, Hanžel J, Ma C, Battat R, Raine T, Siegmund B, Peyrin-Biroulet L, Verstockt B, Torres J, Mehandru S, D'Haens G, Hogan M, Ungaro F, Atreya R, Panés J, Panaccione R, Parker CE, Sands BE, Feagan BG, Danese S, Jairath V

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/41210380

Résumé

Advanced Combination Treatment (ACT) refers to the dual use of two advanced therapies-either two biologics, two small molecules, or one biologic and one small molecule. There is a lack of guidance regarding clinical trial design for ACT in patients with inflammatory bowel disease (IBD). Key uncertainties remain regarding aspects such as eligibility criteria, pharmacotherapy regimens, safety considerations, and standardised trial design configurations for both induction and maintenance phases. We aimed to formulate expert recommendations regarding the design of ACT clinical trials in IBD.