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

NCT07184944 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: EFC183272025-521037-86U1111-1314-5471
• Study Type: interventional
• Target: 671
• Locations: 2 countries
• Sites: 13

Brief Summary

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

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (3)

• Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission (CDAI) at Week 40

  Clinical Remission by Crohn's Disease Activity Index (CDAI): CDAI score \<150. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease.

  Week 40

• Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40

  The SES-CD is a standardized method for evaluating disease activity. Score ranges from 0 to 56, where higher scores represent more severe disease. Endoscopic Response by SES-CD is a decrease in SES-CD ≥50% from Baseline (or a decrease of at least 2 points for participants with a Baseline score of 4 or more, and isolated ileal disease) based on central reading.

  Week 40

• Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission per PRO-2 at Week 40

  Clinical Remission 2-item patient-reported outcome (PRO-2): average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline.

  Week 40

Secondary Outcomes (19)

• Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical response Week 40

  Week 40

• Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving SES-CD endoscopic remission at Week 40

  Week 40

• US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission and endoscopic remission at Week 40

  Week 40

• EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission and endoscopic remission at Week 40

  Week 40

• US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission at Week 40

  Week 40

Study Arms (4)

Duvakitug dose 1

EXPERIMENTAL

Subcutaneous (SC) injection as per protocol

Drug: Duvakitug

Du vakitug dose 2

EXPERIMENTAL

SC injection as per protocol

Drug: Duvakitug

Du vakitug dose 3

EXPERIMENTAL

SC injection as per protocol

Drug: Duvakitug

Placebo

PLACEBO COMPARATOR

SC injection as per protocol

Drug: Placebo

Interventions

Duvakitug DRUG

Pharmaceutical form:Injection solution-Route of administration:SC injection

Also known as: SAR447189

Du vakitug dose 2; Du vakitug dose 3; Duvakitug dose 1

Placebo DRUG

Pharmaceutical form:Injection solution-Route of administration:SC injection

Placebo

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead
• Teva Branded Pharmaceutical Products R&D LLC: collaborator

Study Sites (13)

Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039

Colorado Springs, Colorado, 80907, United States

RECRUITING

Clinical Research of Osceola-Site Number: 8400013

Kissimmee, Florida, 34741, United States

RECRUITING

Bioresearch Partner-Kendale Lakes-Site Number: 8400053

Miami, Florida, 33175, United States

RECRUITING

NMC Research LLC-Site Number: 8400033

Tampa, Florida, 33607, United States

RECRUITING

GI Alliance - Baton Rouge-Site Number: 8400129

Baton Rouge, Louisiana, 70809, United States

RECRUITING

Gateway Gastroenterology-Site Number: 8400097

St Louis, Missouri, 63141, United States

RECRUITING

NYU Langone Health-Site Number: 8400091

New York, New York, 10016, United States

RECRUITING

New York Gastroenterology Associates-Site Number: 8400009

New York, New York, 10075, United States

RECRUITING

Cross Creek Medical Clinic-Site Number: 8400057

Fayetteville, North Carolina, 28304, United States

RECRUITING

Ohio Gastroenterology Group Inc.-Site Number: 8400006

Columbus, Ohio, 43202, United States

RECRUITING

Tyler Research Institute LLC-Site Number: 8400095

Tyler, Texas, 75701, United States

RECRUITING

Gastroenterology Associates of Western Michigan-Site Number: 8400060

Wyoming, Wyoming, 49519, United States

RECRUITING

Investigational Site Number : 1240003

Toronto, M6A 3B4, Canada

RECRUITING

Related Links

• EFC18327 Plain Language Results Summary

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: January 22, 2026
• Primary Completion (Estimated): August 13, 2029
• Study Completion (Estimated): March 20, 2034
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (12); CA (1)