Back to Clinical Trials
Phase 3Recruiting

A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)

Sponsored by Merck Sharp & Dohme LLC

About this study

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).

The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.

Where this study is enrolling (71)

  • University of Arizona Clinical and Translational Sciences Research Center ( Site 5111)

    Tucson, Arizona

    I'm interested

  • GI Alliance - Sun City ( Site 5118)

    Sun City, Arizona

    Call 623-972-2116

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • University of Arkansas for Medical Sciences ( Site 5147)

    Little Rock, Arkansas

    Call 501-398-8622

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Cedars Sinai Medical Center ( Site 5080)

    Los Angeles, California

    Call 310-423-0035

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Southern California Research Center ( Site 5044)

    Coronado, California

    Call 619-522-0330

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

Show all 71 locations

  • Clinical Applications Laboratories ( Site 5123)

    San Diego, California

    Call 619-260-1012

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Om Research LLC ( Site 5045)

    Oxnard, California

    Call 661-388-2239

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Om Research LLC ( Site 5038)

    Lancaster, California

    Call 661-388-2239

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 5128)

    Orange, California

    Call 714-456-7890

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • UCLA Clinical & Translational Research Center (CTRC) ( Site 5116)

    Los Angeles, California

    Call 310-206-3778

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Clinnova Research ( Site 5110)

    Anaheim, California

    Call 949-889-0249

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Peak Gastroenterology Associates ( Site 5023)

    Colorado Springs, Colorado

    Call 719-310-6719

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Rocky Mountain Gastroenterology ( Site 5082)

    Lakewood, Colorado

    Call 303-463-3900

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 5026)

    Aurora, Colorado

    Call 720-848-2777

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • South Denver Gastroenterology, PC ( Site 5132)

    Englewood, Colorado

    Call 303-406-4288

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Yale University School of Medicine-Digestive Disease ( Site 5019)

    New Haven, Connecticut

    Call 203-785-4138

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Emerson Clinical Research Institute ( Site 5051)

    Washington D.C., District of Columbia

    Call 202-239-0777

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • AdventHealth Orlando ( Site 5131)

    Orlando, Florida

    Call 407-303-5503

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Covenant Metabolic Specialists, LLC ( Site 5143)

    University Park, Florida

    Call 941-500-3200

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Covenant Metabolic Specialists, LLC ( Site 5150)

    Fort Myers, Florida

    Call 941-500-3200

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Endoscopic Research Inc ( Site 5061)

    Orlando, Florida

    Call 407-896-1726 ext 314

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Nature Coast Clinical Research - Inverness ( Site 5042)

    Inverness, Florida

    Call 352-341-2100

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Sanchez Clinical Research ( Site 5144)

    Miami, Florida

    Call 305-590-8555

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • USF Health Carol and Frank Morsani Center for Advanced Healthcare ( Site 5039)

    Tampa, Florida

    Call 813-396-2254

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Morehouse School Of Medicine ( Site 5071)

    Atlanta, Georgia

    Call 404-752-1500

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Gastroenterology Associates of Central Georgia ( Site 5048)

    Macon, Georgia

    Call 478-464-2600

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • GI ALLIANCE - GURNEE ( Site 5003)

    Gurnee, Illinois

    Call 224-441-2217

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • University of Chicago Medical Center ( Site 5066)

    Chicago, Illinois

    I'm interested

  • Endeavor Health ( Site 5018)

    Evanston, Illinois

    Call 847-570-2000

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Indiana University Health University Hospital ( Site 5022)

    Indianapolis, Indiana

    Call 317-944-3332

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Iowa Digestive Disease Center ( Site 5007)

    Clive, Iowa

    Call 515-225-6050

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • University of Kansas Medical Center ( Site 5091)

    Kansas City, Kansas

    Call 913-588-6158

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Cotton O'Neil Digestive Health Center ( Site 5033)

    Topeka, Kansas

    Call 785-270-4386

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • University of Louisville Hospital ( Site 5120)

    Louisville, Kentucky

    Call 502-852-1958

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Walter Reed National Military Medical Center ( Site 5006)

    Bethesda, Maryland

    Call 301-295-6814

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Massachusetts General Hospital-Crohn's and Colitis Center ( Site 5037)

    Boston, Massachusetts

    Call 334-836-3341

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Clinical Research Institute of Michigan, LLC ( Site 5002)

    Clinton Township, Michigan

    Call 586-598-3329

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • University of Michigan ( Site 5060)

    Ann Arbor, Michigan

    Call 734-615-4843

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Mayo Clinic in Rochester, Minnesota ( Site 5024)

    Rochester, Minnesota

    Call 507-284-2511

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • BVL Research - Kansas ( Site 5099)

    Liberty, Missouri

    Call 816-222-4241

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Mid-America GI Clinical Research ( Site 5130)

    Kansas City, Missouri

    Call 816-561-2000

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Washington University School of Medicine ( Site 5058)

    St Louis, Missouri

    Call 314-273-0301

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • HMH Justice Marie Garibaldi Medical Plaza ( Site 5072)

    Hackensack, New Jersey

    Call 551-996-1115

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 5078)

    New York, New York

    Call 646-754-3433

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • New York Gastroenterology Associates ( Site 5013)

    New York, New York

    Call 212-369-2490

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Northwell Health Physician Partners Center for Advanced IBD Care ( Site 5017)

    Great Neck, New York

    Call 516-504-3955

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Northwell Mather Hospital ( Site 5138)

    Port Jefferson, New York

    Call 631-686-1409

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Weill Cornell Medical College, New-York Presbyterian Hospital ( Site 5079)

    New York, New York

    Call 646-697-0985

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • University of North Carolina Medical Center ( Site 5034)

    Chapel Hill, North Carolina

    Call 984-974-3777

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Atrium Health Gastroenterology MMP ( Site 5105)

    Charlotte, North Carolina

    Call 704-355-0282

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Great Lakes Gastroenterology Research, LLC ( Site 5016)

    Mentor, Ohio

    Call 440-205-1225

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Digestive Disease Specialists Inc. ( Site 5117)

    Oklahoma City, Oklahoma

    Call 405-702-1300

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Frontier Clinical Research, LLC ( Site 5098)

    Uniontown, Pennsylvania

    Call 724-550-4099

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Thomas Jefferson University Hospital ( Site 5133)

    Philadelphia, Pennsylvania

    Call 609-472-1549

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Penn State University Milton S. Hershey Medical Center ( Site 5102)

    Hershey, Pennsylvania

    Call 800-243-1455

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • University Gastroenterology - Providence - West River Street ( Site 5057)

    Providence, Rhode Island

    Call 401-821-6306

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Sanford USD Medical Center ( Site 5129)

    Sioux Falls, South Dakota

    Call 605-333-1000

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Vanderbilt Inflammatory Bowel Disease Clinic ( Site 5049)

    Nashville, Tennessee

    Call 615-322-2312

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Quality Medical Research ( Site 5114)

    Nashville, Tennessee

    Call 615-835-4750

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Baylor College of Medicine Medical Center ( Site 5020)

    Houston, Texas

    I'm interested

  • Tyler Research Institute ( Site 5001)

    Tyler, Texas

    Call 903-630-6211

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Southern Star Research Institute ( Site 5000)

    San Antonio, Texas

    Call 210-581-2812

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • GI Alliance: Mansfield ( Site 5015)

    Mansfield, Texas

    Call 817-415-9664

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Caprock Gastro Research ( Site 5077)

    Lubbock, Texas

    Call 808-239-1823

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Baylor University Medical Center ( Site 5031)

    Dallas, Texas

    Call 214-820-2687

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Michael E. DeBakey VA Medical Center ( Site 5086)

    Houston, Texas

    Call 713-798-5765

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Epic Medical Research - Mesquite ( Site 5153)

    Denton, Texas

    Call 940-252-0504

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • GI Alliance - Southlake ( Site 5109)

    Southlake, Texas

    Call 817-424-1525

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Richmond VA Medical Center ( Site 5021)

    Richmond, Virginia

    Call 804-675-5000

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • University of Washington ( Site 5115)

    Seattle, Washington

    Call 414-805-3000

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Washington Gastroenterology - Tacoma ( Site 5004)

    Tacoma, Washington

    Call 253-272-5127

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

Who can participate

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

  • ✕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).

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.