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