An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Public ClinicalTrials.gov record NCT07184931. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07184931
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 980 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2025
- Primary completion
- May 13, 2029
- Completion
- May 13, 2029
- Last update posted
- Sep 22, 2026
2025 – 2029
United States locations
- U.S. sites
- 125
- U.S. states
- 36
- U.S. cities
- 108
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Onyx Clinical Research - Site Number:8400021 | Peoria | Arizona | 85381 | Recruiting |
| One of a Kind Clinical Research Center AZ, LLC-Site Number: 8400061 | Scottsdale | Arizona | 85258 | Recruiting |
| Scottsdale Clinical Trials-Site Number: 8400145 | Scottsdale | Arizona | 85260 | Recruiting |
| Del Sol Research Management, LLC-Site Number: 8400012 | Tucson | Arizona | 85715 | Recruiting |
| Preferred Research Partners-Site Number: 8400018 | Little Rock | Arkansas | 72211 | Recruiting |
| Alliance Research Institute-Site Number: 8400008 | Canoga Park | California | 91304 | Recruiting |
| Southern California GI & Liver Centers-Site Number: 8400062 | Coronado | California | 92118-1408 | Recruiting |
| Gastroenterology and Liver Institute - Escondido-Site Number: 8400146 | Escondido | California | 92025 | Recruiting |
| GMC Clinical Research, LLC-Site Number: 8400113 | Folsom | California | 95630 | Recruiting |
| Om Research, LLC - Lancaster-Site Number: 8400148 | Lancaster | California | 93534 | Recruiting |
| TLC Clinical Research Inc.-Site Number: 8400030 | Los Angeles | California | 90048 | Recruiting |
| GastroIntestinal Bioscience - Los Angeles-Site Number: 8400019 | Los Angeles | California | 90067 | Recruiting |
| United Medical Doctors CA-Site Number: 8400044 | Murrieta | California | 92563 | Recruiting |
| Om Research, LLC - Oxnard-Site Number: 8400150 | Oxnard | California | 93030 | Recruiting |
| Prospective Research Innovations Inc.-Site Number: 8400017 | Rancho Cucamonga | California | 91730 | Recruiting |
| UC Davis Health System-Site Number: 8400071 | Sacramento | California | 95817 | Recruiting |
| Clinical Applications Laboratories Inc-Site Number: 8400056 | San Diego | California | 92103 | Recruiting |
| Medical Associates Research Group-Site Number:8400063 | San Diego | California | 92123 | Recruiting |
| Valiance Clinical Research - Tarzana-Site Number: 8400023 | Tarzana | California | 91356 | Recruiting |
| Clinical Trials Management Services-Site Number: 8400047 | Thousand Oaks | California | 91360 | Recruiting |
| Amicis Research Center - Valencia-Site Number: 8400064 | Valencia | California | 91355 | Recruiting |
| Om Research, LLC - Victorville-Site Number: 8400022 | Victorville | California | 92395 | Recruiting |
| UCHealth Digestive Health Center - Anschutz Medical Campus-Site Number: 8400085 | Aurora | Colorado | 80045 | Recruiting |
| Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039 | Colorado Springs | Colorado | 80907 | Recruiting |
| Gastroenterology of the Rockies - Denver-Site Number: 8400122 | Denver | Colorado | 80218 | Recruiting |
| Yale University Digestive Disease-Site Number: 8400108 | New Haven | Connecticut | 06510 | Recruiting |
| Novum Research, LLC-Site Number: 8400003 | Clermont | Florida | 34711 | Recruiting |
| Sarkis Clinical Trials - Gainesville-Site Number: 8400048 | Gainesville | Florida | 32607 | Recruiting |
| Clinical Research of Osceola-Site Number: 8400013 | Kissimmee | Florida | 34741 | Recruiting |
| Columbus Clinical Services LLc-Site Number: 8400038 | Miami | Florida | 33125 | Recruiting |
| Regis Clinical Research, LLC-Site Number: 8400041 | Miami | Florida | 33126 | Recruiting |
| Sylvester Comprehensive Cancer Center - A University of Miami Hospital and Clinics Facility - Miami-Site Number: 8400111 | Miami | Florida | 33136 | Recruiting |
| Medical Professional Clinical Research Center-Site Number: 8400119 | Miami | Florida | 33165 | Recruiting |
| Bioresearch Partner-Kendale Lakes-Site Number: 8400053 | Miami | Florida | 33175 | Recruiting |
| Paradisus Med Research-Site Number: 8400036 | Miami | Florida | 33185 | Recruiting |
| Correa Research Center-Site Number: 8400010 | Miami | Florida | 33186 | Recruiting |
| AdventHealth Orlando-Site Number: 8400070 | Orlando | Florida | 32803 | Recruiting |
| Orlando Health, Inc.-Site Number: 8400084 | Orlando | Florida | 32806 | Recruiting |
| Tropical Clinical Trials-Site Number: 8400082 | Palmetto Bay | Florida | 33176 | Recruiting |
| Precision Clinical Research - Sunrise-Site Number: 8400059 | Sunrise | Florida | 33351 | Recruiting |
| NMC Research LLC-Site Number: 8400033 | Tampa | Florida | 33607 | Recruiting |
| Atlanta Gastroenterology Associates-Site Number: 8400109 | Atlanta | Georgia | 30342 | Recruiting |
| M3 Wake Research - Atlanta-Site Number: 8400028 | Sandy Springs | Georgia | 30328 | Recruiting |
| EBGS Clinical Research Center, LLC-Site Number: 8400037 | Snellville | Georgia | 30078 | Recruiting |
| Atlanta Gastroenterology Specialists-Site Number: 8400149 | Suwanee | Georgia | 30024 | Recruiting |
| Grand Teton Research Group, PLLC-Site Number: 8400127 | Idaho Falls | Idaho | 83404 | Recruiting |
| Rush University Medical Center-Site Number: 8400015 | Chicago | Illinois | 60612 | Recruiting |
| Midwest Digestive Health and Nutrition-Site Number: 8400136 | Des Plaines | Illinois | 60016 | Recruiting |
| GI Alliance - Glenview-Site Number: 8400068 | Glenview | Illinois | 60026 | Recruiting |
| GI Alliance - Gurnee-Site Number: 8400049 | Gurnee | Illinois | 60031 | Recruiting |
| Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100 | New Albany | Indiana | 47150 | Recruiting |
| Heartland Medical Research, Inc.-Site Number: 8400134 | Clive | Iowa | 50325 | Recruiting |
| Digestive Health Research Center-Site Number: 8400096 | Waterloo | Iowa | 50701 | Recruiting |
| University of Kansas Medical Center-Site Number: 8400110 | Kansas City | Kansas | 66160 | Recruiting |
| University of Kentucky Hospital/UK Albert B. Chandler Hospital-Site Number: 8400058 | Lexington | Kentucky | 40536-0293 | Recruiting |
| GI Alliance - Baton Rouge-Site Number: 8400129 | Baton Rouge | Louisiana | 70809 | Recruiting |
| Tandem Intermediate, LLC - Houma-Site Number: 8400034 | Houma | Louisiana | 70360 | Recruiting |
| Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128 | Mandeville | Louisiana | 70471 | Recruiting |
| Tandem Clinical Research - Marrero-Site Number: 8400002 | Marrero | Louisiana | 70072 | Recruiting |
| GI Alliance - Metairie-Site Number: 8400124 | Metairie | Louisiana | 70006 | Recruiting |
| Delta Research Partners-Site Number: 8400087 | Monroe | Louisiana | 71201 | Recruiting |
| Care Access - New Iberia-Site Number: 8400031 | New Iberia | Louisiana | 70560 | Recruiting |
| Mercy Medical Center, Baltimore-Site Number: 8400117 | Baltimore | Maryland | 21202 | Recruiting |
| Mid-Atlantic GI Research, LLC-Site Number: 8400106 | Laurel | Maryland | 20708 | Recruiting |
| Tufts Medical Center-Site Number: 8400126 | Boston | Massachusetts | 02111 | Recruiting |
| UMass Memorial Medical Center-Site Number: 8400121 | Worcester | Massachusetts | 01655 | Recruiting |
| Henry Ford Medical Center - Columbus-Site Number: 8400118 | Novi | Michigan | 48377 | Recruiting |
| Gastroenterology Associates of Western Michigan-Site Number: 8400060 | Wyoming | Michigan | 49519 | Recruiting |
| Allied Health Clinical Research Organization, LLC - Jackson-Site Number:8400007 | Jackson | Mississippi | 08527 | Recruiting |
| BVL Clinical Research-Site Number: 8400005 | Liberty | Missouri | 64068 | Recruiting |
| Washington University School of Medicine-Site Number: 8400075 | St Louis | Missouri | 63110 | Recruiting |
| Gateway Gastroenterology-Site Number: 8400097 | St Louis | Missouri | 63141 | Recruiting |
| Las Vegas Clinical Trials-Site Number: 8400079 | Las Vegas | Nevada | 89030 | Recruiting |
| Sanmora Bespoke Clinical Research Solutions LLC-Site Number: 8400123 | East Orange | New Jersey | 07018 | Recruiting |
| Allied Health Clinical Research Organization, LLC - Freehold-Site Number: 8400014 | Freehold | New Jersey | 07728 | Recruiting |
| Tandem-Allied Clinical Research - Somers Point-Site Number: 8400050 | Somers Point | New Jersey | 08244 | Recruiting |
| Premier Health Research, LLC-Site Number: 8400114 | Sparta | New Jersey | 07871 | Recruiting |
| MedTraits NY-Site Number: 8400045 | Maspeth | New York | 11378 | Recruiting |
| Manhattan Clinical Research, LLC-Site Number: 8400069 | New York | New York | 10016 | Recruiting |
| NYU Langone Health-Site Number: 8400091 | New York | New York | 10016 | Recruiting |
| Columbia University Medical Center-Site Number: 8400138 | New York | New York | 10032 | Recruiting |
| Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040 | New York | New York | 10065 | Recruiting |
| New York Gastroenterology Associates-Site Number: 8400009 | New York | New York | 10075 | Recruiting |
| Montefiore Medical Center - Bronx-Site Number: 8400142 | The Bronx | New York | 10467 | Recruiting |
| UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074 | Chapel Hill | North Carolina | 27514 | Recruiting |
| OnSite Clinical Solutions-Site Number: 8400051 | Charlotte | North Carolina | 28211 | Recruiting |
| Duke University Medical Center-Site Number: 8400093 | Durham | North Carolina | 27710 | Recruiting |
| Cross Creek Medical Clinic-Site Number: 8400057 | Fayetteville | North Carolina | 28304 | Recruiting |
| Monroe Biomedical Research-Site Number: 8400046 | Monroe | North Carolina | 28112 | Recruiting |
| ClinTrial Research, LLC-Site Number: 8400043 | Raleigh | North Carolina | 27612 | Recruiting |
| Plains Clinical Research Center-Site Number: 8400078 | Fargo | North Dakota | 58104 | Recruiting |
| Gastroenterology & Hepatology Specialists, Inc.-Site nUmber: 8400139 | Canton | Ohio | 44718 | Recruiting |
| University Hospitals Cleveland Medical Center-Site Number: 8400073 | Cleveland | Ohio | 44106-5077 | Recruiting |
| Ohio Gastroenterology Group Inc.-8400006 | Columbus | Ohio | 43202 | Recruiting |
| OSU Wexner Medical Center-Site Number: 8400077 | Columbus | Ohio | 43210 | Recruiting |
| DSI Research Northridge - Dayton-Site Number: 8400115 | Dayton | Ohio | 45414 | Recruiting |
| DSI Research - Springboro-Site Number: 8400105 | Springboro | Ohio | 45066 | Recruiting |
| University of Toledo Medical Center-Site Number: 8400042 | Toledo | Ohio | 43614 | Recruiting |
| North Shore Gastroenterology Research-Site Number: 8400130 | Westlake | Ohio | 44145 | Recruiting |
| Central Sooner Research-Site Number: 8400094 | Norman | Oklahoma | 73071 | Recruiting |
| Oregon Health & Science University-Site Number: 8400131 | Portland | Oregon | 97239 | Recruiting |
| Penn State Milton S. Hershey Medical Center-Site Number: 8400066 | Hershey | Pennsylvania | 17033-0850 | Recruiting |
| University of Pennsylvania School of Medicine-Site Number: 8400072 | Philadelphia | Pennsylvania | 19104-6243 | Recruiting |
| The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107 | Pittsburgh | Pennsylvania | 15212 | Recruiting |
| University Gastroenterology-Site Number: 8400103 | Providence | Rhode Island | 02904 | Recruiting |
| Johns Hopkins University Gastroenterology and Hepatology-Site Number: 8400116 | Columbia | South Carolina | 21045 | Recruiting |
| Biocentric Health Research Center-Site Number: 8400089 | Columbia | South Carolina | 29203 | Recruiting |
| Tri-Cities Gastroenterology-Site Number: 8400076 | Kingsport | Tennessee | 37663 | Recruiting |
| Inquest Clinical Research-Site Number: 8400144 | Baytown | Texas | 77521 | Recruiting |
| The University of Texas Southwestern Medical Center-Site Number: 8400098 | Dallas | Texas | 75390 | Recruiting |
| Valley Institute of Research-Site Number: 8400004 | Harlingen | Texas | 78550 | Recruiting |
| One of a Kind Clinical Research Center TX, LLC-Site Number; 8400125 | Kingwood | Texas | 77339 | Recruiting |
| Innovare Research Group-Site number: 8400067 | Lake Jackson | Texas | 77566 | Recruiting |
| GI Alliance - Lubbock-Site Number: 8400092 | Lubbock | Texas | 79410 | Recruiting |
| SMS Clinical Research-Site Number: 8400035 | Mesquite | Texas | 75149 | Recruiting |
| Gastroenterology Research of San Antonio LLC-Site Number: 8400054 | San Antonio | Texas | 78229 | Recruiting |
| Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Corporate Office-Site Number: 8400101 | Southlake | Texas | 76092 | Recruiting |
| Texas Gastro Consultants-Site Number: 8400029 | Tomball | Texas | 77375 | Recruiting |
| Tyler Research Institute, LLC-Site Number: 8400095 | Tyler | Texas | 75701 | Recruiting |
| Velocity Clinical Research, Salt Lake City-Site Number: 8400147 | West Jordan | Utah | 84088 | Recruiting |
| Blue Ridge Medical Research-Site Number: 8400020 | Lynchburg | Virginia | 24502 | Recruiting |
| Clinical Research Partners-Site Number: 8400080 | Richmond | Virginia | 23226 | Recruiting |
| GI Alliance - Bellevue-Site Number: 8400143 | Bellevue | Washington | 98004 | Recruiting |
| The Vancouver Clinic Inc. P.S.-Site Number: 8400090 | Vancouver | Washington | 98664 | Recruiting |
| Froedtert Hospital and the Medical College of Wisconsin-Site Number: 8400081 | Milwaukee | Wisconsin | 53226 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 307 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07184931, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 22, 2026 · Synced Sep 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07184931 live on ClinicalTrials.gov.