A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease (STARSCAPE-2)

Sanofi

Status and phase: Enrolling; Phase 3

Conditions: Crohn's Disease

Treatments: Drug: Duvakitug; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07184944

2025-521037-86 (Registry Identifier)

U1111-1314-5471 (Registry Identifier)

EFC18327

Details and patient eligibility

About

This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). 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 the Pivotal Maintenance Sub-Study
• 240 weeks in OLE Sub-Study

The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study

Enrollment: 751 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 Baseline. (Where locally permissible, participants 16 to <18 years of age who meet the definition of Tanner stage 5 for development)
• Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of STARSCAPE-1
• OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study

Exclusion criteria

• Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator
• Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator

The above information is not intended to contain all considerations relevant to a patient'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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751 participants in 4 patient groups, including a placebo group

Duvakitug dose 1

Experimental group

Description:

Subcutaneous (SC) injection as per protocol

Treatment:

Drug: Duvakitug

Du vakitug dose 2

Experimental group

Description:

SC injection as per protocol

Treatment:

Drug: Duvakitug

Du vakitug dose 3

Experimental group

Description:

SC injection as per protocol

Treatment:

Drug: Duvakitug

Placebo

Placebo Comparator group

Description:

SC injection as per protocol

Treatment:

Drug: Placebo