An Induction 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:Solution for Injection-Route of administration:SC injection
• Placebo — DRUG
  Pharmaceutical form:Solution for injection-Route of administration:SC injection

Study Details

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction 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 35 weeks with: * Screening period * 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction) * 12-week Sub-Study 3 (Extended Induction for non-responders) * 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359) The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.

Key Dates

Start date

Oct 8, 2025

Status verified

Apr 2026

Primary completion

May 9, 2028

Completion

May 9, 2028

Study Design

Enrollment

980 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
• Placebo Comparator: Placebo
  SC injection as per protocol

Primary Outcome Measure

Proportion of participants achieving clinical remission. [ Time Frame: Week 12 ]

Central Contacts

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

Locations (91)

Find similar trials in Peoria, AZ

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