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

A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

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

Study Overview

• Status: Recruiting
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: Placebo; Drug: Duvakitug

• Study Type: Interventional
• Enrollment (Estimated): 751
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Trial Transparency email recommended (Toll free for US & Canada); Phone Number: option 6 800-633-1610; Email: contact-us@sanofi.com

Study Locations

• Canada
  • Toronto, Canada, M6A 3B4
    • Recruiting
    • Investigational Site Number : 1240003
• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Recruiting
      • Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
  • Florida
    • Kissimmee, Florida, United States, 34741
      • Recruiting
      • Clinical Research of Osceola-Site Number: 8400013
    • Miami, Florida, United States, 33175
      • Recruiting
      • Bioresearch Partner-Kendale Lakes-Site Number: 8400053
    • Tampa, Florida, United States, 33607
      • Recruiting
      • NMC Research LLC-Site Number: 8400033
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Recruiting
      • GI Alliance - Baton Rouge-Site Number: 8400129
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Recruiting
      • Gateway Gastroenterology-Site Number: 8400097
  • New York
    • New York, New York, United States, 10075
      • Recruiting
      • New York Gastroenterology Associates-Site Number: 8400009
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health-Site Number: 8400091
  • North Carolina
    • Fayetteville, North Carolina, United States, 28304
      • Recruiting
      • Cross Creek Medical Clinic-Site Number: 8400057
  • Ohio
    • Columbus, Ohio, United States, 43202
      • Recruiting
      • Ohio Gastroenterology Group Inc.-Site Number: 8400006
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • OSU Wexner Medical Center-Site Number: 8400077
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Gastroenterology Research of San Antonio LLC-Site Number: 8400054
    • Tyler, Texas, United States, 75701
      • Recruiting
      • Tyler Research Institute LLC-Site Number: 8400095
  • Wyoming
    • Wyoming, Wyoming, United States, 49519
      • Recruiting
      • Gastroenterology Associates of Western Michigan-Site Number: 8400060

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; SC injection as per protocol	Drug: Placebo; Pharmaceutical form:Injection solution-Route of administration:SC injection
Experimental: Duvakitug dose 1; Subcutaneous (SC) injection as per protocol	Drug: Duvakitug; Pharmaceutical form:Injection solution-Route of administration:SC injection; Other Names: SAR447189
Experimental: Du vakitug dose 2; SC injection as per protocol	Drug: Duvakitug; Pharmaceutical form:Injection solution-Route of administration:SC injection; Other Names: SAR447189
Experimental: Du vakitug dose 3; SC injection as per protocol	Drug: Duvakitug; Pharmaceutical form:Injection solution-Route of administration:SC injection; Other Names: SAR447189

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical response Week 40	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. Clinical Response by CDAI: decrease in CDAI score of 100 points or more from Baseline.	Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving SES-CD endoscopic remission 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 remission: a SES-CD ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD sub score >1 point from Baseline.	Week 40
US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission and endoscopic remission at Week 40	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. The SES-CD is a standardized method for evaluating disease activity. Score ranges from 0 to 56, where higher scores represent more severe disease. Clinical Remission by CDAI: CDAI score <150. Endoscopic remission: a SES-CD ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD sub score >1 point from Baseline.	Week 40
EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission and endoscopic remission at Week 40	Clinical Remission 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. 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 remission: a SES-CD ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD sub score >1 point from Baseline.	Week 40
US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission at Week 40	Clinical Remission 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
EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission at Week 40	Clinical Remission by 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
US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free CDAI clinical remission at Week 40	Clinical Remission by CDAI: CDAI score <150 and without corticosteroid use for CD for at least 12 weeks prior to assessment. 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
EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free PRO-2 remission at Week 40	Clinical Remission 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 and without corticosteroid use for CD for at least 12 weeks prior to assessment.	Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving ulcer-free endoscopy (in the subset of participants with ulcers at Baseline) at Week 40		Week 40
US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission per CDAI at Week 40 in the subset of participants with clinical remission per CDAI at Week 0 (maintenance of clinical remission per CDAI)	Clinical Remission by 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
EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission per PRO-2 at Week 40 in the subset of participants with clinical remission per PRO-2 at Week 0 (maintenance of clinical remission per PRO-2)	Clinical Remission 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
Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in PROMIS-Fatigue Short Form 7a T-score at Week 40	The PROMIS Fatigue Short Form 7a uses a 5-point Likert scale for each of its 7 items, resulting in a raw score range of 7 to 35. This raw score is then converted into a T-score, with a mean of 50 and a standard deviation of 10, based on US national norms. Higher T-scores indicate greater fatigue.	Baseline, Week 40
Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in IBDQ total score at Week 40	Inflammatory Bowel Disease Questionnaire (IBDQ) instrument consist of 32 items exploring 4 dimensions: "bowel symptoms" (10 items), "systemic symptoms" (5 items), "emotional function" (12 items) and "social function" (5 items). The total IBDQ total score ranges from 32 to 224 with higher score indicating better quality of life.	Baseline, Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with no bowel urgency by NRS at Week 40	Numeric Rating Scale (NRS) for bowel urgency measures the severity of bowel urgency-the sudden or immediate need to have a bowel movement-experienced in the past 24 hours. This tool utilizes an 11-point scale for evaluation, where 0 represents "no urgency" and 10 signifies the "worst possible urgency".	Week 40
Pivotal Maintenance Sub-Study Cohort 1: Incidence of CD related hospitalization by Week 40		Week 0 through Week 40
Pivotal Maintenance Sub-Study Cohort 1: Serum concentrations of duvakitug measured over time		Week 0 through Week 40
Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment-emergent antidrug antibody (ADA) against duvakitug		Week 0 through Week 40
Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment-emergent adverse events (TEAEs), TEAE of special interest (TEAESIs), TE serious adverse events (TESAEs) and TEAEs leading to permanent study intervention discontinuation		Week 0 through 45 days after last dose
Open-Label Extension Sub-Study: Incidence of TEAEs, TEAESIs, TESAEs, and TEAEsleading to permanent study intervention discontinuation		Week 40 of pivotal maintenance through 45 days after last dose

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Teva Branded Pharmaceutical Products R&D LLC

Publications and helpful links

Helpful Links

• EFC18327 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2026
• Primary Completion (Estimated): August 13, 2029
• Study Completion (Estimated): March 20, 2034

Study Registration Dates

• First Submitted: September 15, 2025
• First Submitted That Met QC Criteria: September 15, 2025
• First Posted (Actual): September 22, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: EFC18327; 2025-521037-86 (Registry Identifier: CTIS); U1111-1314-5471 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No