IBD Clinical Trials

A phase 2b, multicenter, double-blind, placebo-controlled study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of obefazimod in subjects with moderately to severely active Crohn’s disease.
Sponsor: Abivax (ABX464-202)
PI: Madalina Butnariu, MD

 

A Phase III, multicenter, double-blind, placebo-controlled, treat-through study to assess the efficacy and safety of induction and maintenance therapy with RO7790121 in patients with moderately to severely active Crohn’s disease.
Sponsor: F. Hoffmann-La Roche Ltd (GA45331; Siberite-1)
PI: Madalina Butnariu, MD

A Phase 2a multicenter, randomized, open-label platform study of advanced targeted combination therapies for the treatment of adult subjects with inflammatory bowel disease.
Sponsor: AbbVie (M24-885)
PI: Adeeti Chiplunker, MD

A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn’s disease.
Sponsor: Sanofi (EFC18326)
PI: Madalina Butnariu, MD

A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn’s disease.
Sponsor: Sanofi (EFC18327)
PI: Madalina Butnariu, MD

A Phase 3b, multicenter, randomized, open-label, active-controlled study to compare the efficacy and safety of guselkumab with risankizumab in advanced-therapy for experienced participants with moderately to severely active Crohn’s disease.
Sponsor: J&J (CNTO1959CRD3009)
PI: Adeeti Chiplunker, MD

A Phase 2 platform basket study evaluating advanced therapies in subjects with moderately to severely active Crohn's disease or ulcerative colitis. Investigational products: risankizumab, ABBV-466 (risankizumab/trosunilimab) combination, trosunilimab, ABBV-7066 (risankizumab/ABBV-701) combination, and ABBV-701.
Sponsor: AbbVie (M26-266)
PI: Adeeti Chiplunker, MD

A Phase III, multicenter, double-blind, placebo-controlled study to assess the efficacy and safety of induction therapy with RO7790121 in patients with moderately to severely active Crohn’s disease. IP: RO7790121 (afimkibart).
Sponsor: ROCHE Genentech (GA45332; SIBERITE-2)
PI: Madalina Butnariu, MD

A Phase 2, randomized, double-blind study evaluating the efficacy and safety of duvakitug in participants with fibrostenosing Crohn’s disease.
Sponsor: Sanofi (DRI26648)
PI: Madalina Butnariu, MD

Multicenter, placebo-controlled, randomized, double-blind, Phase 2 study to assess efficacy, safety, tolerability and pharmacokinetics of RXC008 in participants with strictures due to Crohn’s disease following treatment with orally administered RXC008.
Sponsor: RedX Pharma Ltd. (RXC008-0002)
PI: Adeeti Chiplunker, MD

A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active ulcerative colitis.
Sponsor: Sanofi (EFC18359; SUNSCAPE-2)
PI: Madalina Butnariu, MD

A randomized, multicenter, double-blind, placebo-controlled development program to evaluate the efficacy and safety of LY4268989 (MORF-057) for the treatment of adults with moderately to severely active ulcerative colitis. IP: LY4268989 (MORF-057).
Sponsor: Eli Lilly and Company (J6E-MC-KWAM)
PI: Jacob Skeans, MD

A randomized, double-blind, multicenter phase III study to evaluate the long-term efficacy and safety of ABX464 25 mg or 50 mg once daily as a maintenance therapy in subjects with moderately to severely active ulcerative colitis.
Sponsor: Abivax (ABX464-107)
PI: Madalina Butnariu, MD

A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of apraglutide in adult subjects with short bowel syndrome and intestinal failure (SBS-IF).
Sponsor: PSI-CRO (TA799-025)
PI: Adeeti Chiplunker, MD