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

Status: Recruiting
Location: See all (71) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include: The study duration may be up to 35 weeks with: * Up to 5-week 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). * 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 80
Healthy Volunteers: f
View:

• 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 Crohn's Disease (CD) for at least 3 months prior to baseline

• Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)

Locations
United States
Arkansas
Preferred Research Partners: 8400018
RECRUITING
Little Rock
Arizona
Onyx Clinical Research - Site Number: 8400021
RECRUITING
Peoria
Del Sol Research Management, LLC: 8400012
RECRUITING
Tucson
California
Kagoshima IBD Gastroenterology Clinic - Site Number: 8400008
RECRUITING
Canoga Park
Southern California GI & Liver Centers: 8400062
RECRUITING
Coronado
GMC Clinical Research, LLC: 8400113
RECRUITING
Folsom
TLC Clinical Research Inc.: 8400030
RECRUITING
Los Angeles
United Medical Doctors CA: 8400044
RECRUITING
Murrieta
Prospective Research Innovations Inc.: 8400017
RECRUITING
Rancho Cucamonga
Valiance Clinical Research - Tarzana: 8400023
RECRUITING
Tarzana
Clinical Trials Management Services: 8400047
RECRUITING
Thousand Oaks
Amicis Research Center-Valencia: 8400064
RECRUITING
Valencia
Om Research, LLC - Victorville - Site Number: 8400022
RECRUITING
Victorville
Colorado
Peak Gastroenterology Associates - Colorado Springs: 8400039
RECRUITING
Colorado Springs
Florida
Precision Clinical Research: 8400059
RECRUITING
Coral Springs
Sarkis Clinical Trials-Ocala: 8400048
RECRUITING
Gainesville
Clinical Research of Osceola: 8400013
RECRUITING
Kissimmee
Bio Research Partner: 8400053
RECRUITING
Miami
Columbus Clinical Services LLc: 8400038
RECRUITING
Miami
Correa Research Center-Site Number: 8400010
RECRUITING
Miami
Regis Clinical Research, LLC-Site Number: 8400041
RECRUITING
Miami
NMC Research LLC - Site Number: 8400033
RECRUITING
Tampa
Georgia
M3 Wake Research - Atlanta: 8400028
RECRUITING
Sandy Springs
EBGS Clinical Research Center, LLC: 8400037
RECRUITING
Snellville
Illinois
GI Alliance - Glenview - Site Number: 8400068
RECRUITING
Glenview
Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee - Site Number: 8400049
RECRUITING
Gurnee
Indiana
Gastroenterology Health Partners, PLLC - Site Number: 8400100
RECRUITING
New Albany
Louisiana
GI Alliance - Baton Rouge - Site Number: 8400129
RECRUITING
Baton Rouge
GI Alliance - Metairie: 8400124
RECRUITING
Metairie
Delta Research Partners: 8400087
RECRUITING
Monroe
Maryland
Mid-Atlantic GI Research, LLC - Site Number: 8400106
RECRUITING
Greenbelt
Michigan
Gastroenterology Associates of Western Michigan - Site Number: 8400060
RECRUITING
Wyoming
Missouri
Gateway Gastroenterology: 8400097
RECRUITING
Chesterfield
BVL Clinical Research: 8400005
RECRUITING
Liberty
North Carolina
OnSite Clinical Solutions: 8400051
RECRUITING
Charlotte
Cross Creek Medical Clinic: 8400057
RECRUITING
Fayetteville
Monroe Biomedical Research - Site Number: 8400046
RECRUITING
Monroe
ClinTrial Research, LLC - Site Number: 8400043
RECRUITING
Raleigh
North Dakota
Plains Medical Clinic: 8400078
RECRUITING
Fargo
New Jersey
Premier Health Research, LLC - Site Number: 8400114
RECRUITING
Sparta
New York
MedTraits NY: 8400045
RECRUITING
Maspeth
Manhattan Clinical Research, LLC - Site Number: 8400069
RECRUITING
New York
New York Gastroenterology Associates: 8400009
RECRUITING
New York
Ohio
Ohio Gastroenterology Group Inc.: 8400006
RECRUITING
Columbus
DSI Research, LLC: 8400115
RECRUITING
Dayton
DSI Research, LLC - Site Number: 8400105
RECRUITING
Springboro
North Shore Gastroenterology Research - Site Number: 8400130
RECRUITING
Westlake
Oklahoma
Central Sooner Research: 8400094
RECRUITING
Norman
Rhode Island
University Gastroenterology - GI Alliance - Site Number: 8400103
RECRUITING
Providence
South Carolina
Biocentric Health Research Partner: 8400089
RECRUITING
West Columbia
Tennessee
Tri-Cities Gastroenterology: 8400076
RECRUITING
Kingsport
Texas
Valley Institute of Research: 8400004
RECRUITING
Harlingen
Innovare Research Group: 8400067
RECRUITING
Lake Jackson
Texas Digestive Disease Consultants dba GI Alliance - Lubbock - Site Number: 8400092
RECRUITING
Lubbock
Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Site Number: 8400101
RECRUITING
Southlake
Texas Gastro Consultants: 8400029
RECRUITING
Tomball
Tyler Research Institute, LLC: 8400095
RECRUITING
Tyler
Virginia
Blue Ridge Medical Research: 8400020
RECRUITING
Lynchburg
Clinical Research Partners - Site Number: 8400080
RECRUITING
Richmond
Washington
The Vancouver Clinic Inc. P.S. - Site Number: 8400090
RECRUITING
Vancouver
Other Locations
Canada
Investigational Site Number: 1240009
RECRUITING
Hamilton
Investigational Site Number: 1240010
RECRUITING
Oakville
Investigational Site Number: 1240003
RECRUITING
Toronto
Japan
Kagoshima IBD Gastroenterology Clinic Site Number : 3920049
RECRUITING
Kagoshima
Ofuna Chuo Hospital: 3920029
RECRUITING
Kamakura
Kokikai Tsujinaka Hospital Kashiwanoha: 3920031
RECRUITING
Kashiwa
Aoyama Clinic: 3920018
RECRUITING
Kobe
Sapporo Tokushukai Hospital: 3920019
RECRUITING
Sapporo
Tokai University Hachioji Hospital: 3920030
RECRUITING
Tokyo
Toyama University Hospital: 3920032
RECRUITING
Toyama
Puerto Rico
Wellness Clinical Research - Vega Baja: 8400099
RECRUITING
Vega Baja
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
Contact-US@sanofi.com
800-633-1610
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2029-05-14
Participants
Target number of participants: 980
Treatments
Experimental: Duvakitug Dose 1
Subcutaneous (SC) Injection as per protocol
Experimental: Duvakitug Dose 2
SC injection as per protocol
Placebo_comparator: Placebo
SC injection as per protocol
Related Therapeutic Areas
Sponsors
Collaborators: Teva Branded Pharmaceutical Products R&D LLC
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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