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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 16 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Has had a diagnosis of 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 Crohn's disease. - 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-TL1A antibody.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Study 1: High Dose Induction, High Dose Maintenance 		Participants receive high dose intravenous (IV) tulisokibart, followed by a high dose subcutaneous (SC) tulisokibart regimen.
  • Drug: IV Tulisokibart
    Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
    Other names:
    • PRA023
    • MK-7240
  • Drug: SC Tulisokibart
    Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
    Other names:
    • PRA023
    • MK-7240
Experimental
Study 1: High Dose Induction, Low Dose Maintenance 		Participants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
  • Drug: IV Tulisokibart
    Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
    Other names:
    • PRA023
    • MK-7240
  • Drug: SC Tulisokibart
    Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
    Other names:
    • PRA023
    • MK-7240
  • Other: SC Placebo
    Placebo matching SC tulisokibart
Experimental
Study 1: Low Dose Induction, Low Dose Maintenance 		Participants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
  • Drug: IV Tulisokibart
    Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
    Other names:
    • PRA023
    • MK-7240
  • Drug: SC Tulisokibart
    Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
    Other names:
    • PRA023
    • MK-7240
  • Other: SC Placebo
    Placebo matching SC tulisokibart
Placebo Comparator
Study 1: Placebo 		Participants receive IV placebo, followed by an SC placebo regimen.
  • Drug: IV Tulisokibart
    Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
    Other names:
    • PRA023
    • MK-7240
  • Other: IV Placebo
    Placebo matching IV tulisokibart
  • Other: SC Placebo
    Placebo matching SC tulisokibart
Experimental
Study 1: High Dose Extension 		Participants receive a high dose SC tulisokibart regimen. Participants may continue in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
  • Drug: SC Tulisokibart
    Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
    Other names:
    • PRA023
    • MK-7240
Experimental
Study 1: Low Dose Extension 		Participants receive a low dose SC tulisokibart and placebo regimen. Participants may continue in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
  • Drug: SC Tulisokibart
    Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
    Other names:
    • PRA023
    • MK-7240
  • Other: SC Placebo
    Placebo matching SC tulisokibart
Experimental
Study 2: High Dose Induction 		Participants receive high dose IV tulisokibart.
  • Drug: IV Tulisokibart
    Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
    Other names:
    • PRA023
    • MK-7240
Experimental
Study 2: Low Dose Induction 		Participants receive low dose IV tulisokibart.
  • Drug: IV Tulisokibart
    Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
    Other names:
    • PRA023
    • MK-7240
  • Other: SC Placebo
    Placebo matching SC tulisokibart
Placebo Comparator
Study 2: Placebo 		Participants receive IV placebo.
  • Drug: IV Tulisokibart
    Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
    Other names:
    • PRA023
    • MK-7240
  • Other: IV Placebo
    Placebo matching IV tulisokibart
  • Other: SC Placebo
    Placebo matching SC tulisokibart
Experimental
Study 2: High Dose Extension 		Participants receive a high dose SC tulisokibart regimen. Participants may continue in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
  • Drug: SC Tulisokibart
    Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
    Other names:
    • PRA023
    • MK-7240
Experimental
Study 2: Low Dose Extension 		Participants receive a low dose SC tulisokibart regimen. Participants may continue in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
  • Drug: SC Tulisokibart
    Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
    Other names:
    • PRA023
    • MK-7240

Recruiting Locations

Digestive Health Specialists ( Site 5064)
Dothan, Alabama 36301
Contact:
Study Coordinator
334-836-1212

GI Alliance - Sun City ( Site 5118)
Sun City, Arizona 85351
Contact:
Study Coordinator
623-972-2116

University of Arizona Clinical and Translational Sciences Research Center ( Site 5111)
Tucson, Arizona 85724-0001
Contact:
Study Coordinator
520-626-8000

Clinnova Research ( Site 5110)
Anaheim, California 92805
Contact:
Study Coordinator
949-889-0249

Om Research LLC ( Site 5045)
Camarillo, California 93012
Contact:
Study Coordinator
888-577-8839

Southern California Research Center ( Site 5044)
Coronado, California 92118
Contact:
Study Coordinator
619-522-0330

Om Research LLC ( Site 5038)
Lancaster, California 93534
Contact:
Study Coordinator
888-577-8839

Amicis Research Center - Valencia ( Site 5055)
Valencia, California 91355
Contact:
Study Coordinator
888-577-8839

University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 5026)
Aurora, Colorado 80045
Contact:
Study Coordinator
888-577-8839

Peak Gastroenterology Associates ( Site 5023)
Colorado Springs, Colorado 80907
Contact:
Study Coordinator
719-310-6719

Medical Research Center of Connecticut ( Site 5005)
Hamden, Connecticut 06518
Contact:
Study Coordinator
203-281-5161

Emerson Clinical Research Institute ( Site 5051)
Washington, District of Columbia 20009
Contact:
Study Coordinator
202-239-0777

Gastroenterology Consultants of Clearwater ( Site 5052)
Clearwater, Florida 33756
Contact:
Study Coordinator
888-577-8839

Nature Coast Clinical Research - Inverness ( Site 5042)
Inverness, Florida 34452
Contact:
Study Coordinator
352-341-2100

Atlantic Medical Research ( Site 5073)
Margate, Florida 33063
Contact:
Study Coordinator
954-850-0589

Endoscopic Research Inc ( Site 5061)
Orlando, Florida 32803
Contact:
Study Coordinator
888-577-8839

Orlando Health-Digestive Health Institute ( Site 5010)
Orlando, Florida 32806
Contact:
Study Coordinator
321-842-7900

Atlanta Center for Gastroenterology ( Site 5035)
Decatur, Georgia 30033
Contact:
Study Coordinator
404-296-1986

Gastroenterology Associates of Central Georgia ( Site 5048)
Macon, Georgia 31201
Contact:
Study Coordinator
888-577-8839

Eagle Clinical Research ( Site 5089)
Chicago, Illinois 60621
Contact:
Study Coordinator
888-577-8839

University of Chicago Medical Center ( Site 5066)
Chicago, Illinois 60637
Contact:
Study Coordinator
888-577-8839

Endeavor Health ( Site 5018)
Evanston, Illinois 60201
Contact:
Study Coordinator
888-577-8839

GI ALLIANCE - GURNEE ( Site 5003)
Gurnee, Illinois 60031
Contact:
Study Coordinator
224-441-2217

Indiana University Health University Hospital ( Site 5022)
Indianapolis, Indiana 46202
Contact:
Study Coordinator
317-944-3332

Iowa Digestive Disease Center ( Site 5007)
Clive, Iowa 50325
Contact:
Study Coordinator
888-577-8839

Cotton O'Neil Digestive Health Center ( Site 5033)
Topeka, Kansas 66606
Contact:
Study Coordinator
888-577-8839

University of Michigan ( Site 5060)
Ann Arbor, Michigan 48109
Contact:
Study Coordinator
734-615-4843

Clinical Research Institute of Michigan, LLC ( Site 5002)
Clinton Township, Michigan 48038
Contact:
Study Coordinator
888-577-8839

BVL Research - Kansas ( Site 5099)
Liberty, Missouri 64068
Contact:
Study Coordinator
785-217-6559

Washington University School of Medicine ( Site 5058)
Saint Louis, Missouri 63110
Contact:
Study Coordinator
314-273-0301

HMHN Justice Marie Garibaldi Medical Plaza ( Site 5072)
Hackensack, New Jersey 07601
Contact:
Study Coordinator
888-577-8839

Northwell Health Division of Gastroenterology at Great Neck ( Site 5017)
Great Neck, New York 11021
Contact:
Study Coordinator
888-577-8839

Circuit Clinical /Crystal Run Healthcare LLP ( Site 5050)
Middletown, New York 12589
Contact:
Study Coordinator
888-577-8839

NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 5078)
New York, New York 10016
Contact:
Study Coordinator
888-577-8839

Weill Cornell Medical College, New-York Presbyterian Hospital ( Site 5079)
New York, New York 10065
Contact:
Study Coordinator
888-577-8839

New York Gastroenterology Associates ( Site 5013)
New York, New York 10075
Contact:
Study Coordinator
888-577-8839

University of North Carolina Medical Center ( Site 5034)
Chapel Hill, North Carolina 27514
Contact:
Study Coordinator
888-577-8839

Atrium Health Gastroenterology MMP ( Site 5105)
Charlotte, North Carolina 28204
Contact:
Study Coordinator
888-577-8839

Great Lakes Gastroenterology Research, LLC ( Site 5016)
Mentor, Ohio 44060
Contact:
Study Coordinator
440-205-1225

Digestive Disease Specialists Inc. ( Site 5117)
Oklahoma City, Oklahoma 73114
Contact:
Study Coordinator
405-702-1300

Frontier Clinical Research, LLC ( Site 5098)
Uniontown, Pennsylvania 15401
Contact:
Study Coordinator
724-550-4099

University Gastroenterology - Providence - West River Street ( Site 5057)
Providence, Rhode Island 02904
Contact:
Study Coordinator
401-821-6306

Vanderbilt Inflammatory Bowel Disease Clinic ( Site 5049)
Nashville, Tennessee 37204
Contact:
Study Coordinator
615-322-2312

Quality Medical Research ( Site 5114)
Nashville, Tennessee 37211
Contact:
Study Coordinator
615-835-4750

Baylor University Medical Center ( Site 5031)
Dallas, Texas 75246
Contact:
Study Coordinator
888-577-8839

GI Alliance - Dallas - Gaston Avenue ( Site 5054)
Dallas, Texas 75246
Contact:
Study Coordinator
214-323-8500

Baylor College of Medicine Medical Center ( Site 5020)
Houston, Texas 77030
Contact:
Study Coordinator
888-577-8839

GI Alliance - Lubbock ( Site 5012)
Lubbock, Texas 79410
Contact:
Study Coordinator
888-577-8839

Caprock Gastro Research ( Site 5077)
Lubbock, Texas 79424
Contact:
Study Coordinator
334-836-1212

GI Alliance: Mansfield ( Site 5015)
Mansfield, Texas 76063
Contact:
Study Coordinator
817-415-9664

Southern Star Research Institute ( Site 5000)
San Antonio, Texas 78229
Contact:
Study Coordinator
888-577-8839

GI Alliance - Southlake ( Site 5109)
Southlake, Texas 76092-9167
Contact:
Study Coordinator
817-424-1525

Tyler Research Institute ( Site 5001)
Tyler, Texas 75701
Contact:
Study Coordinator
888-577-8839

Richmond VA Medical Center ( Site 5021)
Richmond, Virginia 23249
Contact:
Study Coordinator
888-577-8839

Washington Gastroenterology - Bellevue ( Site 5040)
Bellevue, Washington 98004
Contact:
Study Coordinator
888-577-8839

Swedish Medical Center ( Site 5112)
Seattle, Washington 98104
Contact:
Study Coordinator
206-215-4250

Washington Gastroenterology - Tacoma ( Site 5004)
Tacoma, Washington 98405
Contact:
Study Coordinator
888-577-8839

More Details

NCT ID
NCT06430801
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

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