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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 Sex
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 4059102, Alabama 4829764 36301
Contact:
Study Coordinator
334-836-1212

Arizona Arthritis & Rheumatology Research, PC ( Site 5094)
Phoenix 5308655, Arizona 5551752 85032
Contact:
Study Coordinator
480-443-8400

GI Alliance - Sun City ( Site 5118)
Sun City 5316201, Arizona 5551752 85351
Contact:
Study Coordinator
623-972-2116

University of Arizona Clinical and Translational Sciences Research Center ( Site 5111)
Tucson 5318313, Arizona 5551752 85724
Contact:
Study Coordinator
520-626-8000

Clinnova Research ( Site 5110)
Anaheim 5323810, California 5332921 92805
Contact:
Study Coordinator
949-889-0249

Southern California Research Center ( Site 5044)
Coronado 5339663, California 5332921 92118
Contact:
Study Coordinator
619-522-0330

Om Research LLC ( Site 5038)
Lancaster 5364940, California 5332921 93534
Contact:
Study Coordinator
661-388-2239

Cedars Sinai Medical Center ( Site 5080)
Los Angeles 5368361, California 5332921 90048
Contact:
Study Coordinator
310-423-0035

UCLA Clinical & Translational Research Center (CTRC) ( Site 5116)
Los Angeles 5368361, California 5332921 90095
Contact:
Study Coordinator
310-206-3778

University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 5128)
Orange 5379513, California 5332921 92868
Contact:
Study Coordinator
714-456-7890

Om Research LLC ( Site 5045)
Oxnard 5380184, California 5332921 93030
Contact:
Study Coordinator
661-388-2239

Clinical Applications Laboratories ( Site 5123)
San Diego 5391811, California 5332921 92103
Contact:
Study Coordinator
619-260-1012

Amicis Research Center ( Site 5055)
Valencia 5405288, California 5332921 91355
Contact:
Study Coordinator
818-924-4708

University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 5026)
Aurora 5412347, Colorado 5417618 80045
Contact:
Study Coordinator
720-848-2777

Peak Gastroenterology Associates ( Site 5023)
Colorado Springs 5417598, Colorado 5417618 80907
Contact:
Study Coordinator
719-310-6719

South Denver Gastroenterology, PC ( Site 5132)
Englewood 5421250, Colorado 5417618 80113
Contact:
Study Coordinator
303-406-4288

Rocky Mountain Gastroenterology ( Site 5082)
Lakewood 5427946, Colorado 5417618 80228
Contact:
Study Coordinator
303-463-3900

Yale University School of Medicine-Digestive Disease ( Site 5019)
New Haven 4839366, Connecticut 4831725 06510
Contact:
Study Coordinator
203-785-4138

Emerson Clinical Research Institute ( Site 5051)
Washington D.C. 4140963, District of Columbia 4138106 20009
Contact:
Study Coordinator
202-239-0777

Gastroenterology Consultants of Clearwater ( Site 5052)
Clearwater 4151316, Florida 4155751 33756
Contact:
Study Coordinator
727-476-5746

Nature Coast Clinical Research - Inverness ( Site 5042)
Inverness 4159786, Florida 4155751 34452
Contact:
Study Coordinator
352-341-2100

Atlantic Medical Research ( Site 5073)
Margate 4163407, Florida 4155751 33063
Contact:
Study Coordinator
954-850-0589

Sanchez Clinical Research ( Site 5144)
Miami 4164138, Florida 4155751 33157
Contact:
Study Coordinator
305-590-8555

Endoscopic Research Inc ( Site 5061)
Orlando 4167147, Florida 4155751 32803
Contact:
Study Coordinator
407-896-1726 ext 314

USF Health Carol and Frank Morsani Center for Advanced Healthcare ( Site 5039)
Tampa 4174757, Florida 4155751 33612
Contact:
Study Coordinator
813-396-2254

Covenant Metabolic Specialists, LLC ( Site 5143)
University Park 4176217, Florida 4155751 34201
Contact:
Study Coordinator
941-500-3200

Morehouse School Of Medicine ( Site 5071)
Atlanta 4180439, Georgia 4197000 30310
Contact:
Study Coordinator
404-616-1000

Atlanta Center for Gastroenterology ( Site 5035)
Decatur 4191124, Georgia 4197000 30033
Contact:
Study Coordinator
404-296-1986

Gastroenterology Associates of Central Georgia ( Site 5048)
Macon 4207400, Georgia 4197000 31201
Contact:
Study Coordinator
888-577-8839

Eagle Clinical Research ( Site 5089)
Chicago 4887398, Illinois 4896861 60621
Contact:
Study Coordinator
773-657-8993

University of Chicago Medical Center ( Site 5066)
Chicago 4887398, Illinois 4896861 60637
Contact:
Study Coordinator
773-834-2193

Endeavor Health ( Site 5018)
Evanston 4891382, Illinois 4896861 60201
Contact:
Study Coordinator
847-971-9992

GI ALLIANCE - GURNEE ( Site 5003)
Gurnee 4894861, Illinois 4896861 60031
Contact:
Study Coordinator
224-441-2217

Indiana University Health University Hospital ( Site 5022)
Indianapolis 4259418, Indiana 4921868 46202
Contact:
Study Coordinator
317-944-3332

Iowa Digestive Disease Center ( Site 5007)
Clive 4852065, Iowa 4862182 50325
Contact:
Study Coordinator
515-225-6050

University of Kansas Medical Center ( Site 5091)
Kansas City 4273837, Kansas 4273857 66160
Contact:
Study Coordinator
913-588-6158

Cotton O'Neil Digestive Health Center ( Site 5033)
Topeka 4280539, Kansas 4273857 66606
Contact:
Study Coordinator
888-577-8839

University of Louisville Hospital ( Site 5120)
Louisville 4299276, Kentucky 6254925 40202
Contact:
Study Coordinator
502-852-1958

Walter Reed National Military Medical Center ( Site 5006)
Bethesda 4348599, Maryland 4361885 20889
Contact:
Study Coordinator
301-295-6814

Massachusetts General Hospital-Crohn's and Colitis Center ( Site 5037)
Boston 4930956, Massachusetts 6254926 02114
Contact:
Study Coordinator
334-836-3341

University of Michigan ( Site 5060)
Ann Arbor 4984247, Michigan 5001836 48109
Contact:
Study Coordinator
734-615-4843

Clinical Research Institute of Michigan, LLC ( Site 5002)
Clinton Township 4989133, Michigan 5001836 48038
Contact:
Study Coordinator
586-598-3329

Mayo Clinic in Rochester, Minnesota ( Site 5024)
Rochester 5043473, Minnesota 5037779 55905
Contact:
Study Coordinator
507-284-2511

Mid-America GI Clinical Research ( Site 5130)
Kansas City 4393217, Missouri 4398678 64111
Contact:
Study Coordinator
816-561-2000

BVL Research - Kansas ( Site 5099)
Liberty 4395052, Missouri 4398678 64068
Contact:
Study Coordinator
785-217-6559

Washington University School of Medicine ( Site 5058)
St Louis 4407066, Missouri 4398678 63110
Contact:
Study Coordinator
314-273-0301

HMH Justice Marie Garibaldi Medical Plaza ( Site 5072)
Hackensack 5098706, New Jersey 5101760 07601
Contact:
Study Coordinator
888-577-8839

Northwell Health Physician Partners Center for Advanced IBD Care ( Site 5017)
Great Neck 5119218, New York 5128638 11021
Contact:
Study Coordinator
888-577-8839

NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 5078)
New York 5128581, New York 5128638 10016
Contact:
Study Coordinator
888-577-8839

Weill Cornell Medical College, New-York Presbyterian Hospital ( Site 5079)
New York 5128581, New York 5128638 10065
Contact:
Study Coordinator
888-577-8839

New York Gastroenterology Associates ( Site 5013)
New York 5128581, New York 5128638 10075
Contact:
Study Coordinator
888-577-8839

University of North Carolina Medical Center ( Site 5034)
Chapel Hill 4460162, North Carolina 4482348 27514
Contact:
Study Coordinator
888-577-8839

Atrium Health Gastroenterology MMP ( Site 5105)
Charlotte 4460243, North Carolina 4482348 28204
Contact:
Study Coordinator
888-577-8839

Great Lakes Gastroenterology Research, LLC ( Site 5016)
Mentor 5162645, Ohio 5165418 44060
Contact:
Study Coordinator
440-205-1225

Digestive Disease Specialists Inc. ( Site 5117)
Oklahoma City 4544349, Oklahoma 4544379 73114
Contact:
Study Coordinator
405-702-1300

Thomas Jefferson University Hospital ( Site 5133)
Philadelphia 4560349, Pennsylvania 6254927 19107
Contact:
Study Coordinator
609-472-1549

Frontier Clinical Research, LLC ( Site 5098)
Uniontown 4561859, Pennsylvania 6254927 15401
Contact:
Study Coordinator
724-550-4099

University Gastroenterology - Providence - West River Street ( Site 5057)
Providence 5224151, Rhode Island 5224323 02904
Contact:
Study Coordinator
401-821-6306

Sanford USD Medical Center ( Site 5129)
Sioux Falls 5231851, South Dakota 5769223 57105
Contact:
Study Coordinator
605-333-1000

Vanderbilt Inflammatory Bowel Disease Clinic ( Site 5049)
Nashville 4644585, Tennessee 4662168 37204
Contact:
Study Coordinator
615-322-2312

Quality Medical Research ( Site 5114)
Nashville 4644585, Tennessee 4662168 37211
Contact:
Study Coordinator
615-835-4750

Baylor University Medical Center ( Site 5031)
Dallas 4684888, Texas 4736286 75246
Contact:
Study Coordinator
888-577-8839

GI Alliance - Dallas - Gaston Avenue ( Site 5054)
Dallas 4684888, Texas 4736286 75246
Contact:
Study Coordinator
214-323-8500

Baylor College of Medicine Medical Center ( Site 5020)
Houston 4699066, Texas 4736286 77030
Contact:
Study Coordinator
713-798-5765

Michael E. DeBakey VA Medical Center ( Site 5086)
Houston 4699066, Texas 4736286 77030
Contact:
Study Coordinator
713-798-5765

GI Alliance - Lubbock ( Site 5012)
Lubbock 5525577, Texas 4736286 79410
Contact:
Study Coordinator
888-577-8839

Caprock Gastro Research ( Site 5077)
Lubbock 5525577, Texas 4736286 79424
Contact:
Study Coordinator
808-239-1823

GI Alliance: Mansfield ( Site 5015)
Mansfield 4709013, Texas 4736286 76063
Contact:
Study Coordinator
817-415-9664

Southern Star Research Institute ( Site 5000)
San Antonio 4726206, Texas 4736286 78229
Contact:
Study Coordinator
888-577-8839

GI Alliance - Southlake ( Site 5109)
Southlake 4733313, Texas 4736286 76092-9167
Contact:
Study Coordinator
817-424-1525

Tyler Research Institute ( Site 5001)
Tyler 4738214, Texas 4736286 75701
Contact:
Study Coordinator
888-577-8839

Richmond VA Medical Center ( Site 5021)
Richmond 4781708, Virginia 6254928 23249
Contact:
Study Coordinator
888-577-8839

Washington Gastroenterology - Bellevue ( Site 5040)
Bellevue 5786882, Washington 5815135 98004
Contact:
Study Coordinator
425-454-4768

University of Washington ( Site 5115)
Seattle 5809844, Washington 5815135 98195
Contact:
Study Coordinator
414-805-3000

Washington Gastroenterology - Tacoma ( Site 5004)
Tacoma 5812944, Washington 5815135 98405
Contact:
Study Coordinator
253-272-5127

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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