A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
- Resolved Date
- 2/17/26
- Study Completion
- 3/8/31
- Company
- Teva Branded Pharmaceutical Products R&D LLC
- Ticker
- TEVA
- Type
- Trial Status
- Active Not Recruiting
- Trial Size
- 247
- Volume
- $0
- NCT
- NCT05668013
- Drug Description
- 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.
- Outcome
- YES
- Status
- Resolved
- Settlement Date
- 3/30/26 UTC
- Executive Summary
Yes. The exact trial named in the question, NCT05668013 (RELIEVE UCCD long-term extension), has a sponsor-announced public readout on February 17, 2026. Both Sanofi and Teva explicitly describe this exact Phase 2b maintenance/LTE study as having positive results with clinically meaningful, durable efficacy in ulcerative colitis and Crohn’s disease.
Sanofi states that positive results from the RELIEVE UCCD long-term extension study, identified as NCT05668013, showed durable clinical and endoscopic efficacy maintained over 44 weeks in patients with ulcerative colitis and Crohn’s disease who initially responded to induction. The release headline also says the phase 2b maintenance data demonstrated clinically meaningful durable efficacy.
Teva states that positive results from the RELIEVE UCCD long-term extension study showed durable clinical and endoscopic efficacy maintained over 44 weeks in ulcerative colitis and Crohn’s disease. The release identifies RELIEVE UCCD LTE as the double-blind randomized study evaluating long-term efficacy, safety, and tolerability of duvakitug in UC and CD.
