A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
Summary
The primary objective is to characterize the efficacy TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD) at week 14. Secondary objectives: * To evaluate the efficacy of 2 different doses of TEV-48574 as assessed by multiple standard measures * To evaluate the safety and tolerability of 2 different doses of TEV-48574 * To evaluate the immunogenicity of 2 different dioses of TEV-48574 The study will consist of a screening period of up to 6 weeks (42 days), a 14-week treatment period, and a 4-week follow-up period.
Timeline
- Start
- 2022-09-30
- Primary completion
- 2024-11-12
- Completion
- 2024-11-12
Outcome
Met primary endpoint
paper INTERPRETATION: Duvakitug showed significant evidence for clinical remission versus placebo PMID 42462750 ↗
paper INTERPRETATION: Duvakitug showed significant evidence for endoscopic response versus placebo PMID 42462749 ↗
release “the Phase 2b RELIEVE UCCD study met its primary endpoints in patients with ulcerative colitis (UC) and Crohn’s disease (CD).” tevapharm.com ↗
release “study (clinical study identifier: NCT05499130 ), which demonstrated that patients achieved clinically meaningful response with duvakitug compared to placebo at week 14.” sanofi.com ↗
release “RELIEVE UCCD study, 36% (450 mg dose) and 48% (900 mg dose) of patients treated with duvakitug achieved the primary endpoint” sanofi.com ↗
release “CD cohort of the RELIEVE UCCD study, 26% (450 mg dose) and 48% (900 mg dose) of patients treated with duvakitug achieved the primary endpoint” sanofi.com ↗
Publications
- Reinisch W, Stepek D, Kempinski R, Danese S, Sands BE, Ratiu-Duma B, Singh R, Levine P, Barkay H, Gross N, Abrams K, Jairath V. Efficacy and safety of duvakitug in patients with ulcerative colitis (RELIEVE UCCD): a phase 2b, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2026 Jul 16:S2468-1253(26)00120-2. doi: 10.1016/S2468-1253(26)00120-2. Online ahead of print.
- Jairath V, Kierkus J, Duvall GA, Danese S, Sands BE, Ratiu-Duma B, Singh R, Levine P, Barkay H, Gross N, Abrams K, Reinisch W. Efficacy and safety of duvakitug in patients with Crohn's disease (RELIEVE UCCD): a phase 2b, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2026 Jul 16:S2468-1253(26)00119-6. doi: 10.1016/S2468-1253(26)00119-6. Online ahead of print.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Duvakitug | Monoclonal antibody | 450 mg | Subcutaneous |
| Subject | Duvakitug | Monoclonal antibody | 900 mg | Subcutaneous |
| Subject | Duvakitug | Monoclonal antibody | 1800 mg | Subcutaneous |