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NCT06052059 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)
A Phase 3 study of Ulcerative Colitis, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 1,020
- Enrollment target
- 20
- Study locations
NCT06052059: Active Phase 3 study of Ulcerative Colitis, sponsored by Merck Sharp & Dohme.
NCT06052059 is a Phase 3 study of Ulcerative Colitis that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 1,020 participants, below the 2,049-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06052059, a Phase 3 study of Ulcerative Colitis, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,020 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for
Conditions Studied
Interventions
- DRUG IV Placebo
- DRUG IV Tulisokibart
- DRUG SC Tulisokibart
- DRUG SC Placebo
Study Locations (20)
California
- Clinnova Research ( Site 3803) - Anaheim
- Southern California Research Center ( Site 3828) - Coronado
- UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0113) - La Jolla
- Cedars-Sinai Medical Center ( Site 0119) - Los Angeles
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3851) - Orange
Colorado
- University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 0172) - Aurora
- Peak Gastroenterology Associates ( Site 0116) - Colorado Springs
- South Denver Gastroenterology, PC ( Site 3849) - Englewood
- Rocky Mountain Gastroenterology/Topography Health ( Site 3838) - Littleton
Arizona
- Research Solutions of Arizona ( Site 3816) - Litchfield Park
- One of a Kind Clinical Research Center ( Site 3852) - Scottsdale
- GI Alliance - Sun City ( Site 0103) - Sun City
Connecticut
- Connecticut Clinical Research Institute ( Site 0126) - Bristol
- Medical Research Center of Connecticut ( Site 0151) - Hamden
- Yale University School of Medicine-Digestive Disease ( Site 0163) - New Haven
Alabama
- Digestive Health Specialists ( Site 0135) - Dothan
- IMC-Gulf Coast Gastroenterology ( Site 0157) - Fairhope
Florida
- Gastroenterology Consultants of Clearwater ( Site 0152) - Clearwater
- University of Florida College of Medicine-Gastroenterology ( Site 3821) - Gainesville
District of Columbia
- Emerson Clinical Research Institute ( Site 3820) - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,020 participants |
| Start Date | 2023-10-25 |
| Est. Completion | 2029-08-01 |
| Phase | Phase 3 |
What the registry record for NCT06052059 still lists
NCT06052059 is an interventional study that assigns participants to a tested intervention. Its 1,020 participants enrollment target places it among the larger protocols in the corpus, below the 2,049-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 4 interventions - of which IV Placebo is the first listed.
NCT06052059 names 20 study sites across 7 states, led by California, Colorado, Arizona.
Frequently Asked Questions
What is clinical trial NCT06052059 about?
NCT06052059 is a clinical study titled "A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)". 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 remissi...
What is the current status of trial NCT06052059?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,020 participants. The study started on 2023-10-25. Estimated completion is 2029-08-01.
What conditions does trial NCT06052059 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT06052059?
The interventions under investigation include: IV Placebo (DRUG), IV Tulisokibart (DRUG), SC Tulisokibart (DRUG), SC Placebo (DRUG).
Who is sponsoring clinical trial NCT06052059?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06052059 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06052059's enrollment target sits among peer trials
1,020 11th of 122 higher than 112 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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