A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001) (NCT06052059)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Digestive Health Specialists ( Site 0135) โ Dothan, Alabama
Age range: 16 Years to 80 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (476 Sites)
Showing the first 25 of 476 sites.
- Digestive Health Specialists ( Site 0135) โ Dothan, Alabama
- IMC-Gulf Coast Gastroenterology ( Site 0157) โ Fairhope, Alabama
- Research Solutions of Arizona ( Site 3816) โ Litchfield Park, Arizona
- One of a Kind Clinical Research Center ( Site 3852) โ Scottsdale, Arizona
- GI Alliance - Sun City ( Site 0103) โ Sun City, Arizona
- Clinnova Research ( Site 3803) โ Anaheim, California
- Southern California Research Center ( Site 3828) โ Coronado, California
- UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0113) โ La Jolla, California
- Cedars-Sinai Medical Center ( Site 0119) โ Los Angeles, California
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3851) โ Orange, California
- University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 0172) โ Aurora, Colorado
- Peak Gastroenterology Associates ( Site 0116) โ Colorado Springs, Colorado
- South Denver Gastroenterology, PC ( Site 3849) โ Englewood, Colorado
- Rocky Mountain Gastroenterology/Topography Health ( Site 3838) โ Littleton, Colorado
- Connecticut Clinical Research Institute ( Site 0126) โ Bristol, Connecticut
- Medical Research Center of Connecticut ( Site 0151) โ Hamden, Connecticut
- Yale University School of Medicine-Digestive Disease ( Site 0163) โ New Haven, Connecticut
- Emerson Clinical Research Institute ( Site 3820) โ Washington D.C., District of Columbia
- Gastroenterology Consultants of Clearwater ( Site 0152) โ Clearwater, Florida
- University of Florida College of Medicine-Gastroenterology ( Site 3821) โ Gainesville, Florida
- Nature Coast Clinical Research - Inverness ( Site 3806) โ Inverness, Florida
- Central Florida Gastro Research ( Site 0124) โ Kissimmee, Florida
- Research Associates of South Florida - Miami - Southwest 8th Street ( Site 3810) โ Miami, Florida
- Orlando Health ( Site 0145) โ Orlando, Florida
- USF Health ( Site 0169) โ Tampa, Florida
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Ulcerative Colitis
- Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis โ San Diego, California
- A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants โ Eden Prairie, Minnesota
- CP101 for the Treatment of Ulcerative Colitis โ Boston, Massachusetts
- A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis โ Los Angeles, California
- Angiographic Delivery of AD-MSC for Ulcerative Colitis โ Rochester, Minnesota
Explore by condition: All Ulcerative Colitis clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.