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Clinical Trial ยท PHASE3 ยท Recruiting

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

16 October 2026 NCT07185009 ClinicalTrials.gov โ†—
✅ This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
PHASE3
Participants
ALL
Age Range
16 Years โ€“ 80 Years

About This Trial

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.

Who Can Join?

Inclusion Criteria: * Participants aged โ‰ฅ18 and โ‰ค80 years of age at Baseline. (Where locally permissible, participants 16 to

⚠ Always speak to your doctor before applying to any clinical trial.

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