Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)

Summary

The purpose of this study is to evaluate the efficacy and safety of ontamalimab as maintenance treatment in participants with moderate to severe Crohn's disease (CD).

Timeline

Start

2019-02-06

Primary completion

2021-06-21

Completion

2021-09-13

Outcome

Met primary endpoint

Stopped (Business): “Sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.”

paper significantly more patients who received ontamalimab maintenance therapy than placebo achieved Week 52 clinical remission PMID 38096402 ↗

paper Week 52 clinical remission [25 mg, 53.5% vs 8.2%, p <0.001; 75 mg, 40.2% vs 12.8%, p <0.001] PMID 38096402 ↗

Publications

• Vermeire S, Danese S, Sandborn WJ, Schreiber S, Hanauer S, D'Haens G, Nagy P, Thakur M, Bliss C, Cataldi F, Goetsch M, Gorelick KJ, Reinisch W. Efficacy and Safety of the Anti-mucosal Addressin Cell Adhesion Molecule-1 Antibody Ontamalimab in Patients with Moderate-to-Severe Ulcerative Colitis or Crohn's Disease. J Crohns Colitis. 2024 May 31;18(5):708-719. doi: 10.1093/ecco-jcc/jjad199.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ontamalimab	Monoclonal antibody	25 mg	Subcutaneous
Subject	Ontamalimab	Monoclonal antibody	75 mg	Subcutaneous

Indications