An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease (STARSCAPE-1)

Sanofi

Status and phase: Enrolling; Phase 3

Conditions: Crohn's Disease

Treatments: Drug: Duvakitug; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07184931

EFC18326

U1111-1314-5319 (Registry Identifier)

2025-521036-11 (Registry Identifier)

Details and patient eligibility

About

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include:

The study duration may be up to 35 weeks with:

• Up to 5-week 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).
• 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study.

The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.

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 Crohn's Disease (CD) for at least 3 months prior to baseline
• Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)

Exclusion criteria

• Participants with Ulcerative Colitis (UC) or indeterminate colitis
• Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum
• Prior or current high-grade gastrointestinal (GI) dysplasia
• Participants on treatment with but not on stable doses of conventional therapy prior to baseline
• Participants receiving prohibited medications or therapies
• 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