An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis

Phase 3 Completed 366 enrolled Shire

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

Timeline

Start: 2018-04-04
Primary completion: 2021-07-01
Completion: 2021-07-01

Outcome

Met primary endpoint

registry analysis (superiority test); ONTA 25 mg/ Placebo vs ONTA 25 mg/ONTA 25 mg; p <0.001; Difference in Proportion 0.451 (95% CI 0.296 to 0.572) NCT03290781 ↗

registry analysis (superiority test); ONTA 75 mg/Placebo vs ONTA 75 mg/ONTA 75 mg; p <0.001; Difference in Proportion 0.278 (95% CI 0.142 to 0.401) NCT03290781 ↗

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