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NCT07184944PHASE3Recruiting

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

Sanofi

Start Date

1/22/2026

Completion Date

3/20/2034

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

Eligibility Criteria

Age Range: 16 years to 80 years

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

Interventions

DRUG

Duvakitug

DRUG

Placebo

Interested in This Trial?

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Conditions

Crohn's Disease

Locations

Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039

Colorado Springs, Colorado 80907

United States

Clinical Research of Osceola-Site Number: 8400013

Kissimmee, Florida 34741

United States

Columbus Clinical Services LLc-Site Number: 8400038

Miami, Florida 33125

United States

Bioresearch Partner-Kendale Lakes-Site Number: 8400053

Miami, Florida 33175

United States

Orlando Health, Inc., Digestive Health Institute-Site Number: 8400084

Orlando, Florida 32806

United States

NMC Research LLC-Site Number: 8400033

Tampa, Florida 33607

United States

Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee-Site Number: 8400049

Gurnee, Illinois 60031

United States

Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100

New Albany, Indiana 47150

United States

GI Alliance - Baton Rouge-Site Number: 8400129

Baton Rouge, Louisiana 70809

United States

Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128

Mandeville, Louisiana 70471

United States

GI Alliance - Metairie-Site Number: 8400124

Metairie, Louisiana 70006

United States

Delta Research Partners-Site Number: 8400087

Monroe, Louisiana 71291

United States

BVL Clinical Research-Site Number: 8400005

Liberty, Missouri 64068

United States

Gateway Gastroenterology-Site Number: 8400097

St Louis, Missouri 63141

United States

MedTraits NY-Site Number: 8400045

Maspeth, New York 11378

United States

NYU Langone Health-Site Number: 8400091

New York, New York 10016

United States

Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040

New York, New York 10065

United States

New York Gastroenterology Associates-Site Number: 8400009

New York, New York 10075

United States

UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074

Chapel Hill, North Carolina 27514

United States

Cross Creek Medical Clinic-Site Number: 8400057

Fayetteville, North Carolina 28304

United States

Ohio Gastroenterology Group Inc.-Site Number: 8400006

Columbus, Ohio 43202

United States

Medical Associates Research Group-Site Number: 8400063

Columbus, Ohio 43210

United States

OSU Wexner Medical Center-Site Number: 8400077

Columbus, Ohio 43210

United States

North Shore Gastroenterology Research-Site Number: 8400130

Westlake, Ohio 44145

United States

University of Pennsylvania School of Medicine-Site Number: 8400072

Philadelphia, Pennsylvania 19104-6243

United States

The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107

Pittsburgh, Pennsylvania 15212

United States

University Gastroenterology - GI Alliance-Site Number: 8400103

Providence, Rhode Island 02904

United States

GI Alliance - Lubbock-Site Number: 8400092

Lubbock, Texas 79410

United States

SMS Clinical Research-Site Number: 8400035

Mesquite, Texas 75149

United States

Gastroenterology Research of San Antonio LLC-Site Number: 8400054

San Antonio, Texas 78229

United States

Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake-Site Number: 8400101

Southlake, Texas 76092

United States

Tyler Research Institute LLC-Site Number: 8400095

Tyler, Texas 75701

United States

The Vancouver Clinic Inc. P.S.-Site Number: 8400090

Vancouver, Washington 98664

United States

Gastroenterology Associates of Western Michigan-Site Number: 8400060

Wyoming, Wyoming 49519

United States

Investigational Site Number : 0360001

South Brisbane, Queensland 4101

Australia

Investigational Site Number : 0400002

Salzburg, 5020

Australia

Investigational Site Number : 0400007

Vienna, 1190

Australia

Investigational Site Number : 0560003

Yvoir, 5530

Belgium

Sao Jose do Rio Preto Regional Faculty of Medicine Foundation-Site Number: 0760006

São José do Rio Preto, 15090-000

Brazil

Investigational Site Number : 1000007

Rousse, 7000

Bulgaria

Investigational Site Number : 1000001

Sofia, 1618

Bulgaria

Investigational Site Number : 1240009

Hamilton, L8N 1Y2

Canada

Investigational Site Number : 1240013

London, N6K 1M6

Canada

Investigational Site Number : 1240006

New Westminster, BC V3L 3W4

Canada

Investigational Site Number : 1240003

Toronto, M6A 3B4

Canada

Investigational Site Number : 1560002

Guangzhou, 510655

China

Investigational Site Number : 1560026

Huizhou, 516001

China

Investigational Site Number : 1560020

Shanghai, 200123

China

Investigational Site Number : 1560018

Wuxi, 214023

China

Investigational Site Number: 2030011

Hradec Králové, 500 12

Czechia

Investigational Site Number : 2030013

Prague, 150 00

Czechia

Investigational Site Number : 2680006

Tbilisi, 102

Georgia

Investigational Site Number : 2680008

Tbilisi, 144

Georgia

Investigational Site Number : 2680003

Tbilisi, 159

Georgia

Investigational Site Number : 2680005

Tbilisi, 160

Georgia

Investigational Site Number : 2680002

Tbilisi, 180

Georgia

Investigational Site Number : 2680004

Tbilisi, 180

Georgia

Investigational Site Number : 2760005

Ulm, Baden-Wurttemberg 89081

Germany

Investigational Site Number : 3760001

Jerusalem, 9103102

Israel

Investigational Site Number : 3760002

Tel Aviv, 6423906

Israel

Investigational Site Number : 3800003

Rozzano, 20089

Italy

Investigational Site Number : 3800005

Turin, 10128

Italy

Investigational Site Number : 3920030

Kamakura, 247-0056

Japan

Investigational Site Number : 3920013

Nishinomiya, 663-8501

Japan

Investigational Site Number : 3920009

Tsu, 514-8507

Japan

Investigational Site Number : 4980002

Chisinau, MD-2025

Moldova

Investigational Site Number : 4980003

Chisinau, MD-2025

Moldova

Investigational Site Number : 4980004

Chisinau, MD-2068

Moldova

Investigational Site Number : 5540003

Lower Hutt, 5010

New Zealand

Investigational Site Number : 6160026

Bydgoszcz, 85-229

Poland

Investigational Site Number : 6160030

Kłodzko, 57-300

Poland

Investigational Site Number : 6160034

Lublin, 20-049

Poland

Investigational Site Number : 6160007

Staszów, 28-200

Poland

Investigational Site Number : 6160020

Szczecin, 71-685

Poland

Investigational Site Number : 6160008

Warsaw, 04-501

Poland

Investigational Site Number : 6880002

Belgrade, 11 080

Serbia

Investigational Site Number : 7100004

Durban, 3610

South Africa

Investigational Site Number : 7100001

Kempton Park, 1619

South Africa

Investigational Site Number : 4100008

Busan, 48108

South Korea

Investigational Site Number : 4100007

Gwangju, 61453

South Korea

Investigational Site Number : 4100006

Seoul, 6351

South Korea

Investigational Site Number : 4100002

Seoul, 6973

South Korea

Investigational Site Number : 7560001

Bern, 3012

Switzerland

Investigational Site Number : 1580005

Changhua County, 500209

Taiwan

Investigational Site Number : 8040001

Kyiv, 2002

Ukraine

Investigational Site Number : 8040013

Kyiv, 2091

Ukraine

Investigational Site Number : 8040005

Lviv, 79019

Ukraine

Investigational Site Number : 8040006

Uzhhorod, 88018

Ukraine

Investigational Site Number : 8040010

Vinnytsia, 21013

Ukraine

Investigational Site Number : 8040009

Vinnytsia, 21028

Ukraine