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)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Digestive Health Specialists ( Site 5064) — Dothan, Alabama
Age range: 16 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (499 Sites)
Showing the first 25 of 499 sites.
- Digestive Health Specialists ( Site 5064) — Dothan, Alabama
- Arizona Arthritis & Rheumatology Research, PC ( Site 5094) — Phoenix, Arizona
- GI Alliance - Sun City ( Site 5118) — Sun City, Arizona
- University of Arizona Clinical and Translational Sciences Research Center ( Site 5111) — Tucson, Arizona
- University of Arkansas for Medical Sciences ( Site 5147) — Little Rock, Arkansas
- Clinnova Research ( Site 5110) — Anaheim, California
- Southern California Research Center ( Site 5044) — Coronado, California
- Om Research LLC ( Site 5038) — Lancaster, California
- Cedars Sinai Medical Center ( Site 5080) — Los Angeles, California
- UCLA Clinical & Translational Research Center (CTRC) ( Site 5116) — Los Angeles, California
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 5128) — Orange, California
- Om Research LLC ( Site 5045) — Oxnard, California
- Clinical Applications Laboratories ( Site 5123) — San Diego, California
- Amicis Research Center ( Site 5055) — Valencia, California
- University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 5026) — Aurora, Colorado
- Peak Gastroenterology Associates ( Site 5023) — Colorado Springs, Colorado
- South Denver Gastroenterology, PC ( Site 5132) — Englewood, Colorado
- Rocky Mountain Gastroenterology ( Site 5082) — Lakewood, Colorado
- Medical Research Center of Connecticut ( Site 5005) — Hamden, Connecticut
- Yale University School of Medicine-Digestive Disease ( Site 5019) — New Haven, Connecticut
- Emerson Clinical Research Institute ( Site 5051) — Washington D.C., District of Columbia
- Gastroenterology Consultants of Clearwater ( Site 5052) — Clearwater, Florida
- Covenant Metabolic Specialists, LLC ( Site 5150) — Fort Myers, Florida
- Nature Coast Clinical Research - Inverness ( Site 5042) — Inverness, Florida
- Atlantic Medical Research ( Site 5073) — Margate, Florida
📞 Contact the Study Coordinator
Phone: (888) 577-8839
Email: Trialsites@msd.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Crohn's Disease
- A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD) — Birmingham, Alabama
- A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease — Birmingham, Alabama
- A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. — Sun City, Arizona
- Study to Assess Speed of Onset and Durability of Effectiveness of Upadacitinib in Adult Participants With Moderate to Severe Crohn's Disease (CD) in Real World Clinical Practice. — Blacktown, New South Wales
- Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients — San Francisco, California
- Dietary Therapy and Gut Microbiome in Crohn's Disease and Ulcerative Colitis — Boston, Massachusetts
Explore by condition: All Crohn's Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.