An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis (SUNSCAPE-1)

Sanofi

Status and phase: Enrolling; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo; Drug: Duvakitug

Study type: Interventional

Funder types: Industry

Identifiers

NCT07184996

2025-521035-37 (Registry Identifier)

EFC18325

Details and patient eligibility

About

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.

Enrollment: 980 estimated patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to <18 years of age who meet the definition of Tanner Stage 5 for development
• Confirmed diagnosis of moderately to severely active UC for at least 3 months prior to Baseline
• Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies

Exclusion criteria

• Participants with Crohn's Disease (CD), indeterminate colitis
• Current diagnosis of Ulcerative Proctitis
• Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of >3 bowel resections
• Prior or current high-grade gastrointestinal (GI) dysplasia
• Participants on treatment with but not on stable doses of conventional therapies prior to baseline
• Participants with prohibited medications or therapies prior to baseline
• Participants with previous exposure to anti-TL1A investigational therapy The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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980 participants in 3 patient groups, including a placebo group

Duvakitug - dose 1

Experimental group

Description:

Subcutaneous (SC) injection as per protocol

Treatment:

Drug: Duvakitug

Duvakitug - dose 2

Experimental group

Description:

SC injection as per protocol

Treatment:

Drug: Duvakitug

Placebo

Placebo Comparator group

Description:

SC injection as per protocol

Treatment:

Drug: Placebo