A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)
Public ClinicalTrials.gov record NCT06052059. 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 Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants With Moderately to Severely Active Ulcerative Colitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this protocol is to evaluate the efficacy of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12.
Study identification
- NCT ID
- NCT06052059
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,020 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 24, 2023
- Primary completion
- Jul 31, 2026
- Completion
- Jul 31, 2029
- Last update posted
- Mar 12, 2026
2023 – 2029
United States locations
- U.S. sites
- 76
- U.S. states
- 28
- U.S. cities
- 68
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Digestive Health Specialists ( Site 0135) | Dothan | Alabama | 36301 | — |
| IMC-Gulf Coast Gastroenterology ( Site 0157) | Fairhope | Alabama | 36532 | — |
| Research Solutions of Arizona ( Site 3816) | Litchfield Park | Arizona | 85340 | — |
| One of a Kind Clinical Research Center ( Site 3852) | Scottsdale | Arizona | 85258 | — |
| GI Alliance - Sun City ( Site 0103) | Sun City | Arizona | 85351 | — |
| Clinnova Research ( Site 3803) | Anaheim | California | 92805 | — |
| Southern California Research Center ( Site 3828) | Coronado | California | 92118 | — |
| UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0113) | La Jolla | California | 92037 | — |
| Cedars-Sinai Medical Center ( Site 0119) | Los Angeles | California | 90048 | — |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3851) | Orange | California | 92868 | — |
| University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 0172) | Aurora | Colorado | 80045 | — |
| Peak Gastroenterology Associates ( Site 0116) | Colorado Springs | Colorado | 80907 | — |
| South Denver Gastroenterology, PC ( Site 3849) | Englewood | Colorado | 80113 | — |
| Rocky Mountain Gastroenterology/Topography Health ( Site 3838) | Littleton | Colorado | 80120 | — |
| Connecticut Clinical Research Institute ( Site 0126) | Bristol | Connecticut | 06010 | — |
| Medical Research Center of Connecticut ( Site 0151) | Hamden | Connecticut | 06518 | — |
| Yale University School of Medicine-Digestive Disease ( Site 0163) | New Haven | Connecticut | 06510 | — |
| Emerson Clinical Research Institute ( Site 3820) | Washington D.C. | District of Columbia | 20009 | — |
| Gastroenterology Consultants of Clearwater ( Site 0152) | Clearwater | Florida | 33756 | — |
| University of Florida College of Medicine-Gastroenterology ( Site 3821) | Gainesville | Florida | 32610 | — |
| Nature Coast Clinical Research - Inverness ( Site 3806) | Inverness | Florida | 34452 | — |
| Central Florida Gastro Research ( Site 0124) | Kissimmee | Florida | 34741 | — |
| Research Associates of South Florida - Miami - Southwest 8th Street ( Site 3810) | Miami | Florida | 33134 | — |
| Orlando Health ( Site 0145) | Orlando | Florida | 32806 | — |
| USF Health ( Site 0169) | Tampa | Florida | 33612 | — |
| Emory University School of Medicine ( Site 3818) | Atlanta | Georgia | 30322 | — |
| Atlanta Gastroenterology Associates - Peachtree Dunwoody ( Site 0115) | Atlanta | Georgia | 30342 | — |
| Atlanta Center for Gastroenterology ( Site 0155) | Decatur | Georgia | 30033 | — |
| University of Chicago Medical Center ( Site 0134) | Chicago | Illinois | 60637 | — |
| GI Alliance - Glenview ( Site 0168) | Glenview | Illinois | 60026 | — |
| GI ALLIANCE - GURNEE ( Site 0107) | Gurnee | Illinois | 60031 | — |
| Iowa Digestive Disease Center ( Site 0123) | Clive | Iowa | 50325 | — |
| University of Louisville Hospital-Clinical Trials Unit ( Site 0165) | Louisville | Kentucky | 40202 | — |
| Baton Rouge General Medical Center - Bluebonnet ( Site 0112) | Baton Rouge | Louisiana | 70809 | — |
| Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 0154) | New Orleans | Louisiana | 70112 | — |
| Walter Reed National Military Medical Center ( Site 0121) | Bethesda | Maryland | 20889 | — |
| Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 3835) | Glen Burnie | Maryland | 21061 | — |
| Massachusetts General Hospital-Crohn's and Colitis Center ( Site 0132) | Boston | Massachusetts | 02114 | — |
| University of Michigan ( Site 0143) | Ann Arbor | Michigan | 48109 | — |
| Clinical Research Institute of Michigan, LLC ( Site 0108) | Clinton Township | Michigan | 48038 | — |
| Michigan Center of Medical Research (MICHMER) ( Site 3850) | Farmington Hills | Michigan | 48334 | — |
| Clinical Research Institute of Michigan, LLC ( Site 0150) | Troy | Michigan | 48098 | — |
| Huron Gastroenterology ( Site 3836) | Ypsilanti | Michigan | 48197 | — |
| Mayo Clinic in Rochester, Minnesota ( Site 0147) | Rochester | Minnesota | 55905 | — |
| BVL Research - Kansas ( Site 3847) | Liberty | Missouri | 64068 | — |
| Washington University School of Medicine ( Site 0129) | St Louis | Missouri | 63110 | — |
| Circuit Clinical /Middletown Medical PC ( Site 3831) | Middletown | New York | 10940 | — |
| NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 3846) | New York | New York | 10016 | — |
| Lenox Hill Hospital ( Site 0128) | New York | New York | 10075 | — |
| New York Gastroenterology Associates ( Site 0159) | New York | New York | 10128 | — |
| University of North Carolina Medical Center ( Site 0140) | Chapel Hill | North Carolina | 27514 | — |
| Carolina Digestive Diseases and Endoscopy Center ( Site 3809) | Greenville | North Carolina | 27834 | — |
| Hospital of the University of Pennsylvania ( Site 0170) | Philadelphia | Pennsylvania | 19104 | — |
| University Gastroenterology ( Site 0164) | Providence | Rhode Island | 02904 | — |
| Gastroenterology Associates of Orangeburg ( Site 0149) | Orangeburg | South Carolina | 29118 | — |
| Vanderbilt Inflammatory Bowel Disease Clinic ( Site 0131) | Nashville | Tennessee | 37204 | — |
| Quality Medical Research ( Site 3807) | Nashville | Tennessee | 37211 | — |
| GI Alliance - Garland ( Site 0109) | Garland | Texas | 75044 | — |
| Baylor College of Medicine Medical Center ( Site 3812) | Houston | Texas | 77030 | — |
| The University of Texas Health Science Center at Houston-Internal Medicine-Division of Gastroentero ( Site 0144) | Houston | Texas | 77030 | — |
| Clinical Trial Network ( Site 3819) | Houston | Texas | 77074 | — |
| GI Alliance - Lubbock ( Site 0167) | Lubbock | Texas | 79410 | — |
| Caprock Gastro Research ( Site 0101) | Lubbock | Texas | 79424 | — |
| GI Alliance: Mansfield ( Site 0161) | Mansfield | Texas | 76063 | — |
| CARTA - Clinical Associates In Research Therapeutics Of America ( Site 0122) | San Antonio | Texas | 78212 | — |
| Southern Star Research Institute ( Site 0106) | San Antonio | Texas | 78229 | — |
| GI Alliance - San Marcos ( Site 0130) | San Marcos | Texas | 78666 | — |
| GI Alliance - Southlake ( Site 0104) | Southlake | Texas | 76092-9167 | — |
| Tyler Research Institute ( Site 0105) | Tyler | Texas | 75701 | — |
| Texas Digestive Disease Consultants ( Site 0136) | Webster | Texas | 77598 | — |
| Velocity Clinical Research, Salt Lake City ( Site 3801) | West Jordan | Utah | 84088 | — |
| Richmond VA Medical Center ( Site 3845) | Richmond | Virginia | 23249 | — |
| Washington Gastroenterology - Bellevue ( Site 3844) | Bellevue | Washington | 98004-4631 | — |
| University of Washington Medical Center - Montlake ( Site 0137) | Seattle | Washington | 98195 | — |
| Washington Gastroenterology - Tacoma ( Site 0102) | Tacoma | Washington | 98405 | — |
| Medical College of Wisconsin ( Site 0141) | Milwaukee | Wisconsin | 53226 | — |
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 400 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06052059, 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 Mar 12, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06052059 live on ClinicalTrials.gov.