Recruiting INTERVENTIONAL NCT07185009

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis (SUNSCAPE-2)

A Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled, Phase 3 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Sponsor: Sanofi

Conditions Ulcerative Colitis

Interventions Duvakitug Placebo

Updated 5 times since 2025 Last updated: Apr 27, 2026 Started: Jan 16, 2026 Primary completion: Sep 21, 2028 Completion: Apr 28, 2033

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Ulcerative Colitis and is currently actively recruiting participants. Sanofi leads this study, which shows 5 recorded versions since 2026 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

5 versions recorded

May 4, 2026 — Present [daily]

Recruiting

Phase: PHASE3 → None
Mar 2026 — May 2026 [monthly]

Recruiting PHASE3
Feb 2026 — Mar 2026 [monthly]

Recruiting PHASE3
Nov 2025 — Feb 2026 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Oct 2025 — Nov 2025 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include: The study duration may be up to 286 weeks including: * 40-week Pivotal Maintenance Sub-Study * 240-week Open-Label Extension (OLE) Sub-Study * 45-day Follow-up Visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit. The treatment duration may be up to 280 weeks including: * 40 weeks in Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visit will be up to 32: * 21 visits in the Pivotal Maintenance Sub-Study. * 11 visits in the OLE Sub-Study.

Contact Information

Sponsor contact:

Sanofi
Teva Branded Pharmaceutical Products R&D LLC

Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Baton Rouge, United States , Belgrade, Serbia , Belgrade, Serbia , Colorado Springs, United States , Columbus, United States , Coronado, United States , Fayetteville, United States , Fort Myers, United States , Hachiōji, Japan , Kamakura, Japan and 10 more locations