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

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

  • Crohn's Disease

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, 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
Contact:
Study Coordinator
520-626-8000

University of Arkansas for Medical Sciences ( Site 5147)
Little Rock, Arkansas 72205
Contact:
Study Coordinator
501-398-8622

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

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
661-388-2239

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

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

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

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

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

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

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

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

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

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

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

Covenant Metabolic Specialists, LLC ( Site 5150)
Fort Myers, Florida 33912
Contact:
Study Coordinator
941-500-3200

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

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

AdventHealth Orlando ( Site 5131)
Orlando, Florida 32803
Contact:
Study Coordinator
407-303-5503

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

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

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

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

Gastroenterology Associates of Central Georgia ( Site 5048)
Macon, Georgia 31201
Contact:
Study Coordinator
478-464-2600

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

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

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
515-225-6050

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

Cotton O'Neil Digestive Health Center ( Site 5033)
Topeka, Kansas 66606
Contact:
Study Coordinator
785-270-4386

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

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

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

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
586-598-3329

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

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

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

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

HMH Justice Marie Garibaldi Medical Plaza ( Site 5072)
Hackensack, New Jersey 07601
Contact:
Study Coordinator
551-996-1115

Northwell Health Physician Partners Center for Advanced IBD Care ( Site 5017)
Great Neck, New York 11021
Contact:
Study Coordinator
516-504-3955

NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 5078)
New York, New York 10016
Contact:
Study Coordinator
646-754-3433

Weill Cornell Medical College, New-York Presbyterian Hospital ( Site 5079)
New York, New York 10065
Contact:
Study Coordinator
646-697-0985

New York Gastroenterology Associates ( Site 5013)
New York, New York 10075
Contact:
Study Coordinator
212-369-2490

Northwell Mather Hospital ( Site 5138)
Port Jefferson, New York 11777
Contact:
Study Coordinator
631-686-1409

University of North Carolina Medical Center ( Site 5034)
Chapel Hill, North Carolina 27514
Contact:
Study Coordinator
984-974-3777

Atrium Health Gastroenterology MMP ( Site 5105)
Charlotte, North Carolina 28204
Contact:
Study Coordinator
704-355-0282

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

Penn State University Milton S. Hershey Medical Center ( Site 5102)
Hershey, Pennsylvania 17033
Contact:
Study Coordinator
800-243-1455

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

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

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

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
214-820-2687

Epic Medical Research - Mesquite ( Site 5153)
Denton, Texas 76201
Contact:
Study Coordinator
940-252-0504

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

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

GI Alliance - Lubbock ( Site 5012)
Lubbock, Texas 79410
Contact:
Study Coordinator
806-793-3141

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

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
210-581-2812

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
903-630-6211

Richmond VA Medical Center ( Site 5021)
Richmond, Virginia 23249
Contact:
Study Coordinator
804-675-5000

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

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

Washington Gastroenterology - Tacoma ( Site 5004)
Tacoma, Washington 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.