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Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
NCT06651281 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06651281
The ClinicalTrials.gov registry entry for NCT06651281 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,380 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06651281 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Texas, Other, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06651281?
The interventions under investigation include: Tulisokibart (DRUG), Placebo to tulisokibart (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06651281?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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