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NCT06430801 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
A Phase 3 study of Crohn's Disease, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,200
- Enrollment target
- 20
- Study locations
NCT06430801 is a Phase 3 study of Crohn's Disease that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 1,200 participants, below the 2,383-participant average among 105 other Crohn's Disease trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 6 states.
The verdict
NCT06430801, a Phase 3 study of Crohn's Disease, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,200 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 1,200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,383-participant average among 105 other Crohn's Disease trials with a reported enrollment target (50% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
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.
NCT06430801 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Colorado, Arizona.
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.
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).
Who is sponsoring clinical trial NCT06430801?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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