A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
Merck Sharp & Dohme LLC · NCT06430801
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 16–80 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 1200
- US sites recruiting
- 71
- Study start
- June 5, 2024
- Record last updated
- October 23, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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).
Being studied: IV Tulisokibart; SC Tulisokibart; IV Placebo; SC Placebo
Conditions: Crohn's Disease
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria
- Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.
- Has moderately to severely active CD.
- Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.
- Adolescent participants ≥16 and \<18 years of age can participate if approved by the country or regulatory/health authority.
Exclusion Criteria
- Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
- Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
- Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
- Has current stoma or need for colostomy or ileostomy.
- Is missing >2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
- Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD.
- Has surgical bowel resection within 3 months of study.
- Has prior or current gastrointestinal dysplasia.
- Has chronic infection requiring ongoing antimicrobial treatment.
- Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years.
- Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- Has active tuberculosis.
- Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.
- Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).
Recruiting US locations
GI Alliance - Sun City ( Site 5118)
Sun City, AZ 85351
Site contact: Study Coordinator · 623-972-2116
University of Arizona Clinical and Translational Sciences Research Center ( Site 5111)
Tucson, AZ 85724
Site contact: Study Coordinator · 520-626-8000
University of Arkansas for Medical Sciences ( Site 5147)
Little Rock, AR 72205
Site contact: Study Coordinator · 501-398-8622
Clinnova Research ( Site 5110)
Anaheim, CA 92805
Site contact: Study Coordinator · 949-889-0249
Southern California Research Center ( Site 5044)
Coronado, CA 92118
Site contact: Study Coordinator · 619-522-0330
Om Research LLC ( Site 5038)
Lancaster, CA 93534
Site contact: Study Coordinator · 661-388-2239
Cedars Sinai Medical Center ( Site 5080)
Los Angeles, CA 90048
Site contact: Study Coordinator · 310-423-0035
UCLA Clinical & Translational Research Center (CTRC) ( Site 5116)
Los Angeles, CA 90095
Site contact: Study Coordinator · 310-206-3778
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 5128)
Orange, CA 92868
Site contact: Study Coordinator · 714-456-7890
Om Research LLC ( Site 5045)
Oxnard, CA 93030
Site contact: Study Coordinator · 661-388-2239
Clinical Applications Laboratories ( Site 5123)
San Diego, CA 92103
Site contact: Study Coordinator · 619-260-1012
University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 5026)
Aurora, CO 80045
Site contact: Study Coordinator · 720-848-2777
Peak Gastroenterology Associates ( Site 5023)
Colorado Springs, CO 80907
Site contact: Study Coordinator · 719-310-6719
South Denver Gastroenterology, PC ( Site 5132)
Englewood, CO 80113
Site contact: Study Coordinator · 303-406-4288
Rocky Mountain Gastroenterology ( Site 5082)
Lakewood, CO 80228
Site contact: Study Coordinator · 303-463-3900
Yale University School of Medicine-Digestive Disease ( Site 5019)
New Haven, CT 06510
Site contact: Study Coordinator · 203-785-4138
Emerson Clinical Research Institute ( Site 5051)
Washington D.C., DC 20009
Site contact: Study Coordinator · 202-239-0777
Covenant Metabolic Specialists, LLC ( Site 5150)
Fort Myers, FL 33912
Site contact: Study Coordinator · 941-500-3200
Nature Coast Clinical Research - Inverness ( Site 5042)
Inverness, FL 34452
Site contact: Study Coordinator · 352-341-2100
Sanchez Clinical Research ( Site 5144)
Miami, FL 33157
Site contact: Study Coordinator · 305-590-8555
AdventHealth Orlando ( Site 5131)
Orlando, FL 32803
Site contact: Study Coordinator · 407-303-5503
Endoscopic Research Inc ( Site 5061)
Orlando, FL 32803
Site contact: Study Coordinator · 407-896-1726 ext 314
USF Health Carol and Frank Morsani Center for Advanced Healthcare ( Site 5039)
Tampa, FL 33612
Site contact: Study Coordinator · 813-396-2254
Covenant Metabolic Specialists, LLC ( Site 5143)
University Park, FL 34201
Site contact: Study Coordinator · 941-500-3200
Morehouse School Of Medicine ( Site 5071)
Atlanta, GA 30310
Site contact: Study Coordinator · 404-616-1000
Gastroenterology Associates of Central Georgia ( Site 5048)
Macon, GA 31201
Site contact: Study Coordinator · 478-464-2600
University of Chicago Medical Center ( Site 5066)
Chicago, IL 60637
Site contact: Study Coordinator · 773-834-2193
Endeavor Health ( Site 5018)
Evanston, IL 60201
Site contact: Study Coordinator · 847-971-9992
GI ALLIANCE - GURNEE ( Site 5003)
Gurnee, IL 60031
Site contact: Study Coordinator · 224-441-2217
Indiana University Health University Hospital ( Site 5022)
Indianapolis, IN 46202
Site contact: Study Coordinator · 317-944-3332
Iowa Digestive Disease Center ( Site 5007)
Clive, IA 50325
Site contact: Study Coordinator · 515-225-6050
University of Kansas Medical Center ( Site 5091)
Kansas City, KS 66160
Site contact: Study Coordinator · 913-588-6158
Cotton O'Neil Digestive Health Center ( Site 5033)
Topeka, KS 66606
Site contact: Study Coordinator · 785-270-4386
University of Louisville Hospital ( Site 5120)
Louisville, KY 40202
Site contact: Study Coordinator · 502-852-1958
Walter Reed National Military Medical Center ( Site 5006)
Bethesda, MD 20889
Site contact: Study Coordinator · 301-295-6814
Massachusetts General Hospital-Crohn's and Colitis Center ( Site 5037)
Boston, MA 02114
Site contact: Study Coordinator · 334-836-3341
University of Michigan ( Site 5060)
Ann Arbor, MI 48109
Site contact: Study Coordinator · 734-615-4843
Clinical Research Institute of Michigan, LLC ( Site 5002)
Clinton Township, MI 48038
Site contact: Study Coordinator · 586-598-3329
Mayo Clinic in Rochester, Minnesota ( Site 5024)
Rochester, MN 55905
Site contact: Study Coordinator · 507-284-2511
Mid-America GI Clinical Research ( Site 5130)
Kansas City, MO 64111
Site contact: Study Coordinator · 816-561-2000
BVL Research - Kansas ( Site 5099)
Liberty, MO 64068
Site contact: Study Coordinator · 816-222-4241
Washington University School of Medicine ( Site 5058)
St Louis, MO 63110
Site contact: Study Coordinator · 314-273-0301
HMH Justice Marie Garibaldi Medical Plaza ( Site 5072)
Hackensack, NJ 07601
Site contact: Study Coordinator · 551-996-1115
Northwell Health Physician Partners Center for Advanced IBD Care ( Site 5017)
Great Neck, NY 11021
Site contact: Study Coordinator · 516-504-3955
NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 5078)
New York, NY 10016
Site contact: Study Coordinator · 646-754-3433
Weill Cornell Medical College, New-York Presbyterian Hospital ( Site 5079)
New York, NY 10065
Site contact: Study Coordinator · 646-697-0985
New York Gastroenterology Associates ( Site 5013)
New York, NY 10075
Site contact: Study Coordinator · 212-369-2490
Northwell Mather Hospital ( Site 5138)
Port Jefferson, NY 11777
Site contact: Study Coordinator · 631-686-1409
University of North Carolina Medical Center ( Site 5034)
Chapel Hill, NC 27514
Site contact: Study Coordinator · 984-974-3777
Atrium Health Gastroenterology MMP ( Site 5105)
Charlotte, NC 28204
Site contact: Study Coordinator · 704-355-0282
Great Lakes Gastroenterology Research, LLC ( Site 5016)
Mentor, OH 44060
Site contact: Study Coordinator · 440-205-1225
Digestive Disease Specialists Inc. ( Site 5117)
Oklahoma City, OK 73114
Site contact: Study Coordinator · 405-702-1300
Penn State University Milton S. Hershey Medical Center ( Site 5102)
Hershey, PA 17033
Site contact: Study Coordinator · 800-243-1455
Thomas Jefferson University Hospital ( Site 5133)
Philadelphia, PA 19107
Site contact: Study Coordinator · 609-472-1549
Frontier Clinical Research, LLC ( Site 5098)
Uniontown, PA 15401
Site contact: Study Coordinator · 724-550-4099
University Gastroenterology - Providence - West River Street ( Site 5057)
Providence, RI 02904
Site contact: Study Coordinator · 401-821-6306
Sanford USD Medical Center ( Site 5129)
Sioux Falls, SD 57105
Site contact: Study Coordinator · 605-333-1000
Vanderbilt Inflammatory Bowel Disease Clinic ( Site 5049)
Nashville, TN 37204
Site contact: Study Coordinator · 615-322-2312
Quality Medical Research ( Site 5114)
Nashville, TN 37211
Site contact: Study Coordinator · 615-835-4750
Baylor University Medical Center ( Site 5031)
Dallas, TX 75246
Site contact: Study Coordinator · 214-820-2687
+ 11 more on the official record.
Study contacts (from the official record)
- Toll Free Number · 1-888-577-8839 · Trialsites@msd.com