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

Conditions

• Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

16 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Duvakitug — DRUG
  Pharmaceutical form: Injection solution Route of administration: SC injection
• Placebo — DRUG
  Pharmaceutical form:Injection solution-Route of administration:SC injection

Study Details

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.

Key Dates

Start date

Jan 16, 2026

Status verified

May 2026

Primary completion

Sep 21, 2028

Completion

Apr 28, 2033

Study Design

Enrollment

671 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Duvakitug - dose 1
  Subcutaneous (SC) injection as per protocol
• Experimental: Duvakitug - dose 2
  SC injection as per protocol
• Experimental: Duvakitug - dose 3
  SC injection as per protocol
• Placebo Comparator: Placebo
  SC injection as per protocol

Primary Outcome Measure

Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by modified Mayo Score (mMS). [ Time Frame: Week 40 ]

Central Contacts

• Trial Transparency email recommended (Toll free for US & Canada)
  800-633-1610
  [email protected]

Locations (21)

Find similar trials in Coronado, CA

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