A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease

Summary

The primary objective of the study is to evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 4 weeks (Q4W) in adult participants with inflammatory bowel disease (IBD). Secondary objectives of the study are to: * evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD * evaluate the safety and tolerability of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD * evaluate the immunogenicity of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD The total duration for a participant in the double-blind period only is 66 weeks; and for a participant in the open-label extension (OLE) period, up to an additional 268 weeks.

Timeline

Start

2023-01-11

Primary completion

2026-01-05

Completion

2031-03-08

Outcome

Met primary endpoint

release “UC: 58% (900 mg) and 47% (450 mg) of patients treated with duvakitug achieved the primary endpoint of clinical remission” tevapharm.com ↗

release “CD: 55% (900 mg) and 41% (450 mg) of patients treated with duvakitug achieved the primary endpoint of endoscopic response” tevapharm.com ↗

Publications

• Solitano V, Jairath V, Ungaro F, Peyrin-Biroulet L, Danese S. TL1A inhibition for inflammatory bowel disease treatment: From inflammation to fibrosis. Med. 2024 May 10;5(5):386-400. doi: 10.1016/j.medj.2024.03.010. Epub 2024 Apr 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Duvakitug	Monoclonal antibody	—	Subcutaneous

Indications