ClinicalTrials.gov record
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT07184996
Public ClinicalTrials.gov record NCT07184996. 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 Ulcerative Colitis.
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 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.
Study identification
- NCT ID
- NCT07184996
- 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
- Oct 7, 2025
- Primary completion
- May 8, 2028
- Completion
- May 8, 2028
- Last update posted
- Aug 19, 2026
2025 – 2028
United States locations
- U.S. sites
- 118
- U.S. states
- 33
- U.S. cities
- 104
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Onyx Clinical Research - Site Number: 8400021 | Peoria | Arizona | 85381 | Recruiting |
| One of a Kind Clinical Research Center 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 |
| FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027 | Arcadia | California | 91006 | 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 |
| 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 |
| United Medical Doctors CA - Site Number: 8400044 | Murrieta | California | 92563 | Recruiting |
| Om Research, LLC - Oxnard - Site Number: 8400150 | Oxnard | California | 93030 | 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 |
| Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025 | Santa Maria | California | 93458 | 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 | 32803 | Recruiting |
| Precision Clinical Research-Site Number: 8400059 | Coral Springs | Florida | 33065 | Recruiting |
| Sarkis Clinical Trials-Ocala - 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 |
| Bio Research Partner - Site Number: 8400053 | Miami | Florida | 33155 | Recruiting |
| Medical Professional Clinical Research Center - Site Number: 8400119 | Miami | Florida | 33165 | Recruiting |
| Paradisus Med Research - Site Number: 8400036 | Miami | Florida | 33185 | Recruiting |
| Correa Research Center-Site Number: 8400010 | Miami | Florida | 33186 | Recruiting |
| Orlando Health, Inc. - Site Number: 8400084 | Orlando | Florida | 32806 | Recruiting |
| AdventHealth Orlando - Site Number: 8400070 | Orlando | Florida | 90067 | Recruiting |
| Tropical Clinical Trials - Site Number: 8400082 | Palmetto Bay | Florida | 33176 | 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 |
| Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee - Site Number: 8400049 | Gurnee | Illinois | 60031 | Recruiting |
| Gastroenterology Health Partners, PLLC - Site Number: 8400100 | New Albany | Indiana | 47150 | Recruiting |
| Iowa Digestive Disease Center - Site Number: 8400134 | Clive | Iowa | 50325 | Recruiting |
| Cedar Valley Digestive Health 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 | 70072 | Recruiting |
| GastroGroup - 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 | Monroe | Louisiana | 71291 | 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 | Greenbelt | Maryland | 20770 | Recruiting |
| Tufts Medical Center - Site Number: 8400126 | Boston | Massachusetts | 02111 | Not yet recruiting |
| UMass Memorial Medical Center - Site Number: 8400121 | Worcester | Massachusetts | 01655 | Recruiting |
| Gastroenterology Associates of Western Michigan - Site Number: 8400060 | Wyoming | Michigan | 49519 | Recruiting |
| Gateway Gastroenterology - Site Number: 8400097 | Chesterfield | Missouri | 63017 | Recruiting |
| BVL Clinical Research - Site Number: 8400005 | Liberty | Missouri | 64068 | Recruiting |
| Las Vegas Clinical Trials - Site Number: 8400079 | Las Vegas | Nevada | 89128 | Recruiting |
| SMS Clinical Research - Site Number: 8400035 | Mesquite | Nevada | 75043 | 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 |
| Allied Health Clinical Research Organization, LLC - Jackson - Site Number: 8400007 | Jackson | New Jersey | 08527 | Recruiting |
| Tandem-Allied Clinical Research - Somers Point - Site Number: 840050 | 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 |
| Weill Cornell Medical College - NewYork-Presbyterian Hospital - Site Number: 8400040 | New York | New York | 10065 | Recruiting |
| Lenox Hill Hospital - Site Number: 8400052 | New York | New York | 10075 | 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 Medical Clinic - Site Number: 8400078 | Fargo | North Dakota | 58104 | Recruiting |
| Gastroenterology & Hepatology Specialists, Inc. - Site Number: 8400139 | Canton | Ohio | 44718 | Recruiting |
| Ohio Gastroenterology Group Inc. - Site Number: 8400006 | Columbus | Ohio | 43202 | Recruiting |
| OSU Wexner Medical Center - Site Number: 8400077 | Columbus | Ohio | 43210 | Recruiting |
| DSI Research, LLC - Site Number: 8400115 | Dayton | Ohio | 45414 | Recruiting |
| DSI Research, LLC - 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, Center for Health and Healing 2 - Site Number: 8400131 | Portland | Oregon | 97239-3098 | 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 - GI Alliance - Site Number: 8400103 | Providence | Rhode Island | 02904 | Recruiting |
| Biocentric Health Research Partner | West Columbia | South Carolina | 29169 | 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 LLC - Texas - Site Number: 8400125 | Kingwood | Texas | 77339 | Recruiting |
| Innovare Research Group - Site Number: 8400067 | Lake Jackson | Texas | 77566 | Recruiting |
| Texas Digestive Disease Consultants dba GI Alliance - Lubbock - Site Number: 8400092 | Lubbock | Texas | 79410 | Recruiting |
| Gastroenterology Research of San Antonio LLC - Site Number: 8400054 | San Antonio | Texas | 78229 | Recruiting |
| Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - 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 |
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 101 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07184996, 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 Aug 19, 2026 · Synced Sep 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07184996 live on ClinicalTrials.gov.