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NCT06651281 · ClinicalTrials.gov registry record · Phase 3
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
A Phase 3 study of Crohn Disease and Colitis, Ulcerative, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,380
- Enrollment target
- 20
- Study locations
NCT06651281: Recruiting Phase 3 study of Crohn Disease and Colitis, Ulcerative, sponsored by Merck Sharp & Dohme.
NCT06651281 is a Phase 3 study of Crohn Disease and Colitis, Ulcerative that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 1,380 participants, above the 186-participant average among 71 other Crohn Disease trials with a reported enrollment target (642% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06651281, a Phase 3 study of Crohn Disease and Colitis, Ulcerative, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,380 participants
- Enrollment target
- 20
- Study locations
Study Summary
Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.
Primary Outcome
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Conditions Studied
Interventions
- DRUG Tulisokibart
- DRUG Placebo to tulisokibart
Study Locations (20)
Texas
- GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290) - Garland
- GI Alliance - Lubbock ( Site 0288) - Lubbock
- Caprock Gastro Research ( Site 0293) - Lubbock
- Southern Star Research Institute ( Site 0299) - San Antonio
- GI Alliance - Southlake ( Site 0298) - Southlake
- Tyler Research Institute ( Site 0294) - Tyler
Other
- Hepato-Gastroenterologie HK ( Site 0700) - Hradec Králové
- ARENSIA Exploratory Medicine Georgia ( Site 1104) - Tbilisi
Connecticut
- Connecticut Clinical Research Institute ( Site 0297) - Bristol
Michigan
- St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287) - Ypsilanti
Missouri
- BVL Research - Kansas ( Site 0292) - Liberty
New York
- New York Gastroenterology Associates ( Site 0253) - New York
Virginia
- University of Virginia Health System ( Site 0291) - Charlottesville
Washington
- Washington Gastroenterology - Tacoma ( Site 0295) - Tacoma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,380 participants |
| Start Date | 2024-11-25 |
| Est. Completion | 2037-12-17 |
| Phase | Phase 3 |
What NCT06651281 shows while recruiting
NCT06651281 is an interventional study that assigns participants to a tested intervention. Its 1,380 participants enrollment target places it among the larger protocols in the corpus, above the 186-participant average among 71 other Crohn Disease trials with a reported enrollment target (642% higher).
The record links to 2 conditions, with Crohn Disease appearing as the primary indexed condition, and to 2 interventions - of which Tulisokibart is the first listed.
NCT06651281 names 20 study sites across 14 states, led by Texas, Other, Connecticut.
Frequently Asked Questions
What is clinical trial NCT06651281 about?
NCT06651281 is a clinical study titled "Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)". Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in c...
What is the current status of trial NCT06651281?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,380 participants. The study started on 2024-11-25. Estimated completion is 2037-12-17.
What conditions does trial NCT06651281 study?
This clinical trial studies the following conditions: Crohn Disease, Colitis, Ulcerative.
What interventions are being tested in trial NCT06651281?
The interventions under investigation include: Tulisokibart (DRUG), Placebo to tulisokibart (DRUG).
Who is sponsoring clinical trial NCT06651281?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06651281 being conducted?
This trial has 20 study locations across Connecticut, Michigan, Missouri, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06651281's enrollment target sits among peer trials
1,380 1st of 71 higher than 71 of 71 other Crohn Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn Disease 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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