A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

NCT07185009 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: EFC183592025-521038-27
• Study Type: interventional
• Target: 671
• Locations: 4 countries
• Sites: 20

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). 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 Pivotal Maintenance Sub-Study
• 240 weeks in OLE Sub-Study The total number of on-site visit will be up to 32:
• 21 visits in the Pivotal Maintenance Sub-Study.
• 11 visits in the OLE Sub-Study.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by modified Mayo Score (mMS).

  Mayo Score is a composite index designed to measure UC disease activity. The score ranges from 0 to 9 with higher scores indicating greater disease severity. Clinical remission is defined as mMS score of 0 to 2, including SFS of 0 or 1, RBS of 0, and mMES of 0 or 1 (score of 1 modified to exclude friability)

  Week 40

Secondary Outcomes (16)

• Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic improvement.

  Week 40

• Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving histologic endoscopic mucosal improvement.

  Week 40

• Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with corticosteroid-free clinical remission.

  Week 40

• Proportion of participants with no bowel urgency.

  Week 40

• Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in PROMIS-Fatigue Short Form 7a T-score.

  Baseline, Week 40

Study Arms (4)

Duvakitug - dose 1

EXPERIMENTAL

Subcutaneous (SC) injection as per protocol

Drug: Duvakitug

Duvakitug - dose 2

EXPERIMENTAL

SC injection as per protocol

Drug: Duvakitug

Duvakitug - 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

Duvakitug - dose 1; Duvakitug - dose 2; Duvakitug - dose 3

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 SUNSCAPE-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 participant's potential participation in a clinical trial.

Sponsors & Collaborators

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

Study Sites (20)

Southern California GI & Liver Centers - Site Number: 8400062

Coronado, California, 92118, United States

RECRUITING

Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039

Colorado Springs, Colorado, 80907, United States

RECRUITING

Royal Palm Clinical Research - Site Number: 8400065

Fort Myers, Florida, 33901, 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, 33155, 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

Delta Research Partners - Site Number: 8400087

Monroe, Louisiana, 71291, United States

RECRUITING

BVL Clinical Research - Site Number: 8400005

Liberty, Missouri, 64068, 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

Investigational Site Number : 1240003

Toronto, Ontario, M6A 3B4, Canada

RECRUITING

Tokai University Hachioji Hospital - Site Number : 3920031

Hachiōji, 192-0032, Japan

RECRUITING

Investigational Site Number : 3920030

Kamakura, 247-0056, Japan

RECRUITING

Investigational Site Number : 3920019

Kobe, 650-0015, Japan

RECRUITING

Investigational Site Number : 3920029

Sapporo, 004-0041, Japan

RECRUITING

Investigational Site Number : 6880001

Belgrade, 11,000, Serbia

RECRUITING

Investigational Site Number : 6880002

Belgrade, 11000, Serbia

RECRUITING

Related Links

• EFC18359 Plain Language Results Summary

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic 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 16, 2026
• Primary Completion (Estimated): September 21, 2028
• Study Completion (Estimated): April 28, 2033
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

JP (4); CA (1); SE (2); US (13)