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

NCT ID: NCT07184996

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

980 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-08

Study Completion Date

2028-05-09

Brief Summary

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This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction 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 35 weeks with:

* 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)
* 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359)

The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Duvakitug - dose 1

Subcutaneous (SC) injection as per protocol

Group Type EXPERIMENTAL

Duvakitug

Intervention Type DRUG

Pharmaceutical form:Solution for Injection-Route of administration:SC injection

Duvakitug - dose 2

SC injection as per protocol

Group Type EXPERIMENTAL

Duvakitug

Intervention Type DRUG

Pharmaceutical form:Solution for Injection-Route of administration:SC injection

Placebo

SC injection as per protocol

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:SC injection

Interventions

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Duvakitug

Pharmaceutical form:Solution for Injection-Route of administration:SC injection

Intervention Type DRUG

Placebo

Pharmaceutical form:Solution for injection-Route of administration:SC injection

Intervention Type DRUG

Other Intervention Names

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SAR447189

Eligibility Criteria

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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 UC for at least 3 months prior to Baseline
* Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies

Exclusion Criteria

* Participants with Crohn's Disease (CD), indeterminate colitis
* Current diagnosis of Ulcerative Proctitis
* Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of \>3 bowel resections
* Prior or current high-grade gastrointestinal (GI) dysplasia
* Participants on treatment with but not on stable doses of conventional therapies prior to baseline
* Participants with prohibited medications or therapies prior to baseline
* 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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D LLC

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027

Arcadia, California, United States

Site Status RECRUITING

GMC Clinical Research, LLC - Site Number: 8400113

Folsom, California, United States

Site Status RECRUITING

TLC Clinical Research Inc. - Site Number: 8400030

Los Angeles, California, United States

Site Status RECRUITING

United Medical Doctors CA - Site Number: 8400044

Murrieta, California, United States

Site Status RECRUITING

Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025

Santa Maria, California, United States

Site Status RECRUITING

Valiance Clinical Research - Tarzana - Site Number: 8400023

Tarzana, California, United States

Site Status RECRUITING

Amicis Research Center-Valencia -Site Number: 8400064

Valencia, California, United States

Site Status RECRUITING

Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039

Colorado Springs, Colorado, United States

Site Status RECRUITING

Precision Clinical Research-Site Number: 8400059

Coral Springs, Florida, United States

Site Status RECRUITING

Sarkis Clinical Trials-Ocala - Site Number: 8400048

Gainesville, Florida, United States

Site Status RECRUITING

Clinical Research of Osceola - Site Number: 8400013

Kissimmee, Florida, United States

Site Status RECRUITING

Columbus Clinical Services LLc - Site Number: 8400038

Miami, Florida, United States

Site Status RECRUITING

Regis Clinical Research, LLC - Site Number: 8400041

Miami, Florida, United States

Site Status RECRUITING

Bio Research Partner - Site Number: 8400053

Miami, Florida, United States

Site Status RECRUITING

Correa Research Center-Site Number: 8400010

Miami, Florida, United States

Site Status RECRUITING

M3 Wake Research - Atlanta - Site Number: 8400028

Sandy Springs, Georgia, United States

Site Status RECRUITING

Delta Research Partners

Monroe, Louisiana, United States

Site Status RECRUITING

Gateway Gastroenterology - Site Number: 8400097

Chesterfield, Missouri, United States

Site Status RECRUITING

BVL Clinical Research - Site Number: 8400005

Liberty, Missouri, United States

Site Status RECRUITING

MedTraits NY - Site Number: 8400045

Maspeth, New York, United States

Site Status RECRUITING

New York Gastroenterology Associates - Site Number: 8400009

New York, New York, United States

Site Status RECRUITING

OnSite Clinical Solutions - Site Number: 8400051

Charlotte, North Carolina, United States

Site Status RECRUITING

Cross Creek Medical Clinic - Site Number: 8400057

Fayetteville, North Carolina, United States

Site Status RECRUITING

Plains Medical Clinic - Site Number: 8400078

Fargo, North Dakota, United States

Site Status RECRUITING

Ohio Gastroenterology Group Inc. - Site Number: 8400006

Columbus, Ohio, United States

Site Status RECRUITING

Central Sooner Research - Site Number: 8400094

Norman, Oklahoma, United States

Site Status RECRUITING

Biocentric Health Research Partner

West Columbia, South Carolina, United States

Site Status RECRUITING

Valley Institute of Research - Site Number: 8400004

Harlingen, Texas, United States

Site Status RECRUITING

Tyler Research Institute, LLC - Site Number: 8400095

Tyler, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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

Role: CONTACT

[email protected]
800-633-1610 ext. option 6

Related Links

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https://sanofi.trialsummaries.com/Study/StudyDetails?id=26860&tenant=MT_SNY_9011

EFC18325 Plain Language Results Summary

Other Identifiers

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2025-521035-37

Identifier Type: REGISTRY

Identifier Source: secondary_id

EFC18325

Identifier Type: -

Identifier Source: org_study_id

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