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A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
NCT06430801 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. 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 per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). 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 per Crohn's Disease Activity Index score (\<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).
Conditions Studied
Interventions
- DRUG IV Tulisokibart
- DRUG SC Tulisokibart
- OTHER IV Placebo
- OTHER SC Placebo
Study Locations (20)
California
- Clinnova Research ( Site 5110) — Anaheim
- Southern California Research Center ( Site 5044) — Coronado
- Om Research LLC ( Site 5038) — Lancaster
- Cedars Sinai Medical Center ( Site 5080) — Los Angeles
- UCLA Clinical & Translational Research Center (CTRC) ( Site 5116) — Los Angeles
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 5128) — Orange
- Om Research LLC ( Site 5045) — Oxnard
- Clinical Applications Laboratories ( Site 5123) — San Diego
- Amicis Research Center ( Site 5055) — Valencia
Colorado
- University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 5026) — Aurora
- Peak Gastroenterology Associates ( Site 5023) — Colorado Springs
- South Denver Gastroenterology, PC ( Site 5132) — Englewood
- Rocky Mountain Gastroenterology ( Site 5082) — Lakewood
Arizona
- Arizona Arthritis & Rheumatology Research, PC ( Site 5094) — Phoenix
- GI Alliance - Sun City ( Site 5118) — Sun City
- University of Arizona Clinical and Translational Sciences Research Center ( Site 5111) — Tucson
Connecticut
- Medical Research Center of Connecticut ( Site 5005) — Hamden
- Yale University School of Medicine-Digestive Disease ( Site 5019) — New Haven
Alabama
- Digestive Health Specialists ( Site 5064) — Dothan
Arkansas
- University of Arkansas for Medical Sciences ( Site 5147) — Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,200 participants |
| Start Date | 2024-06-05 |
| Est. Completion | 2029-11-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06430801
The ClinicalTrials.gov registry entry for NCT06430801 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 1,200 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 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 4 interventions — of which IV 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: NCT06430801 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Colorado, Arizona. 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 NCT06430801 about?
NCT06430801 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)". The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical...
What is the current status of trial NCT06430801?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,200 participants. The study started on 2024-06-05. Estimated completion is 2029-11-12.
What conditions does trial NCT06430801 study?
This clinical trial studies the following conditions: Crohn's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06430801?
The interventions under investigation include: IV Tulisokibart (DRUG), SC Tulisokibart (DRUG), IV Placebo (OTHER), SC Placebo (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06430801?
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 NCT06430801 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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