Recruiting

Phase 3

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

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06430801

Conditions

Crohn's Disease

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Interventions

IV Tulisokibart

SC Tulisokibart

IV Placebo

SC Placebo

Study Details

Brief summary:

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).

Conditions

Crohn's Disease

Study ID

NCT06430801

Start date

Jun 5, 2024

Status verified date

Aug, 2026

Completion date

Nov 12, 2029

Anticipated

Primary completion date

Oct 30, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

1200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

experimental: Study 1: High Dose Induction, Low Dose Maintenance

Participants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.

experimental: Study 1: Low Dose Induction, Low Dose Maintenance

Participants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.

placebo comparator: Study 1: Placebo

Participants receive IV placebo, followed by an SC placebo regimen.

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.

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.

experimental: Study 2: High Dose Induction

Participants receive high dose IV tulisokibart.

experimental: Study 2: Low Dose Induction

Participants receive low dose IV tulisokibart.

placebo comparator: Study 2: Placebo

Participants receive IV placebo.

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.

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.

Interventions

IV Tulisokibart

Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously

SC Tulisokibart

Humanized monoclonal antibody that binds human TL1A, administered subcutaneously

IV Placebo

Placebo matching IV tulisokibart

SC Placebo

Placebo matching SC tulisokibart

Primary outcome measure

Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52 [ Time Frame: Week 52 ]
Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52 [ Time Frame: Week 52 ]
Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52 [ Time Frame: Week 52 ]
Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12 [ Time Frame: Week 12 ]
Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12 [ Time Frame: Week 12 ]
Study 1: Percentage of Participants Achieving Endoscopic Response at Week 12 [ Time Frame: Week 12 ]
Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12 [ Time Frame: Week 12 ]
Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12 [ Time Frame: Week 12 ]
Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12 [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

GI Alliance - Sun City ( Site 5118)

Recruiting

Sun City, Arizona, United States, 85351

Contacts

Study Coordinator

623-972-2116

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

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Study Coordinator

520-626-8000

University of Arkansas for Medical Sciences ( Site 5147)

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Study Coordinator

501-398-8622

Clinnova Research ( Site 5110)

Recruiting

Anaheim, California, United States, 92805

Contacts

Study Coordinator

949-889-0249

Southern California Research Center ( Site 5044)

Recruiting

Coronado, California, United States, 92118

Contacts

Study Coordinator

619-522-0330

Om Research LLC ( Site 5038)

Recruiting

Lancaster, California, United States, 93534

Contacts

Study Coordinator

661-388-2239

Cedars Sinai Medical Center ( Site 5080)

Recruiting

Los Angeles, California, United States, 90048

Contacts

Study Coordinator

310-423-0035

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

Recruiting

Los Angeles, California, United States, 90095

Contacts

Study Coordinator

310-206-3778

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

Recruiting

Orange, California, United States, 92868

Contacts

Study Coordinator

714-456-7890

Om Research LLC ( Site 5045)

Recruiting

Oxnard, California, United States, 93030

Contacts

Study Coordinator

661-388-2239

Clinical Applications Laboratories ( Site 5123)

Recruiting

San Diego, California, United States, 92103

Contacts

Study Coordinator

619-260-1012

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

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Study Coordinator

720-848-2777

Peak Gastroenterology Associates ( Site 5023)

Recruiting

Colorado Springs, Colorado, United States, 80907

Contacts

Study Coordinator

719-310-6719

South Denver Gastroenterology, PC ( Site 5132)

Recruiting

Englewood, Colorado, United States, 80113

Contacts

Study Coordinator

303-406-4288

Rocky Mountain Gastroenterology ( Site 5082)

Recruiting

Lakewood, Colorado, United States, 80228

Contacts

Study Coordinator

303-463-3900

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

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Study Coordinator

203-785-4138

Emerson Clinical Research Institute ( Site 5051)

Recruiting

Washington D.C., District of Columbia, United States, 20009

Contacts

Study Coordinator

202-239-0777

Covenant Metabolic Specialists, LLC ( Site 5150)

Recruiting

Fort Myers, Florida, United States, 33912

Contacts

Study Coordinator

941-500-3200

Nature Coast Clinical Research - Inverness ( Site 5042)

Recruiting

Inverness, Florida, United States, 34452

Contacts

Study Coordinator

352-341-2100

Sanchez Clinical Research ( Site 5144)

Recruiting

Miami, Florida, United States, 33157

Contacts

Study Coordinator

305-590-8555

AdventHealth Orlando ( Site 5131)

Recruiting

Orlando, Florida, United States, 32803

Contacts

Study Coordinator

407-303-5503

Endoscopic Research Inc ( Site 5061)

Recruiting

Orlando, Florida, United States, 32803

Contacts

Study Coordinator

407-896-1726 ext 314

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

Recruiting

Tampa, Florida, United States, 33612

Contacts

Study Coordinator

813-396-2254

Covenant Metabolic Specialists, LLC ( Site 5143)

Recruiting

University Park, Florida, United States, 34201

Contacts

Study Coordinator

941-500-3200

Morehouse School Of Medicine ( Site 5071)

Recruiting

Atlanta, Georgia, United States, 30310

Contacts

Study Coordinator

404-616-1000

Gastroenterology Associates of Central Georgia ( Site 5048)

Recruiting

Macon, Georgia, United States, 31201

Contacts

Study Coordinator

478-464-2600

University of Chicago Medical Center ( Site 5066)

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Study Coordinator

773-834-2193

Endeavor Health ( Site 5018)

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Study Coordinator

847-971-9992

GI ALLIANCE - GURNEE ( Site 5003)

Recruiting

Gurnee, Illinois, United States, 60031

Contacts

Study Coordinator

224-441-2217

Indiana University Health University Hospital ( Site 5022)

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Study Coordinator

317-944-3332

Iowa Digestive Disease Center ( Site 5007)

Recruiting

Clive, Iowa, United States, 50325

Contacts

Study Coordinator

515-225-6050

University of Kansas Medical Center ( Site 5091)

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Study Coordinator

913-588-6158

Cotton O'Neil Digestive Health Center ( Site 5033)

Recruiting

Topeka, Kansas, United States, 66606

Contacts

Study Coordinator

785-270-4386

University of Louisville Hospital ( Site 5120)

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Study Coordinator

502-852-1958

Walter Reed National Military Medical Center ( Site 5006)

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

Study Coordinator

301-295-6814

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

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Study Coordinator

334-836-3341

University of Michigan ( Site 5060)

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Study Coordinator

734-615-4843

Clinical Research Institute of Michigan, LLC ( Site 5002)

Recruiting

Clinton Township, Michigan, United States, 48038

Contacts

Study Coordinator

586-598-3329

Mayo Clinic in Rochester, Minnesota ( Site 5024)

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Study Coordinator

507-284-2511

Mid-America GI Clinical Research ( Site 5130)

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Study Coordinator

816-561-2000

BVL Research - Kansas ( Site 5099)

Recruiting

Liberty, Missouri, United States, 64068

Contacts

Study Coordinator

785-217-6559

Washington University School of Medicine ( Site 5058)

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Study Coordinator

314-273-0301

HMH Justice Marie Garibaldi Medical Plaza ( Site 5072)

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Study Coordinator

551-996-1115

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

Recruiting

Great Neck, New York, United States, 11021

Contacts

Study Coordinator

516-504-3955

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

Recruiting

New York, New York, United States, 10016

Contacts

Study Coordinator

646-754-3433

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

Recruiting

New York, New York, United States, 10065

Contacts

Study Coordinator

646-697-0985

New York Gastroenterology Associates ( Site 5013)

Recruiting

New York, New York, United States, 10075

Contacts

Study Coordinator

212-369-2490

Northwell Mather Hospital ( Site 5138)

Recruiting

Port Jefferson, New York, United States, 11777

Contacts

Study Coordinator

631-686-1409

University of North Carolina Medical Center ( Site 5034)

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Study Coordinator

984-974-3777

Atrium Health Gastroenterology MMP ( Site 5105)

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Study Coordinator

704-355-0282

Great Lakes Gastroenterology Research, LLC ( Site 5016)

Recruiting

Mentor, Ohio, United States, 44060

Contacts

Study Coordinator

440-205-1225

Digestive Disease Specialists Inc. ( Site 5117)

Recruiting

Oklahoma City, Oklahoma, United States, 73114

Contacts

Study Coordinator

405-702-1300

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

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Study Coordinator

800-243-1455

Thomas Jefferson University Hospital ( Site 5133)

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Study Coordinator

609-472-1549

Frontier Clinical Research, LLC ( Site 5098)

Recruiting

Uniontown, Pennsylvania, United States, 15401

Contacts

Study Coordinator

724-550-4099

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

Recruiting

Providence, Rhode Island, United States, 02904

Contacts

Study Coordinator

401-821-6306

Sanford USD Medical Center ( Site 5129)

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Study Coordinator

605-333-1000

Vanderbilt Inflammatory Bowel Disease Clinic ( Site 5049)

Recruiting

Nashville, Tennessee, United States, 37204

Contacts

Study Coordinator

615-322-2312

Quality Medical Research ( Site 5114)

Recruiting

Nashville, Tennessee, United States, 37211

Contacts

Study Coordinator

615-835-4750

Baylor University Medical Center ( Site 5031)

Recruiting

Dallas, Texas, United States, 75246

Contacts

Study Coordinator

214-820-2687

Epic Medical Research - Mesquite ( Site 5153)

Recruiting

Denton, Texas, United States, 76201

Contacts

Study Coordinator

940-252-0504

Baylor College of Medicine Medical Center ( Site 5020)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

713-798-5765

Michael E. DeBakey VA Medical Center ( Site 5086)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

713-798-5765

Caprock Gastro Research ( Site 5077)

Recruiting

Lubbock, Texas, United States, 79424

Contacts

Study Coordinator

808-239-1823

GI Alliance: Mansfield ( Site 5015)

Recruiting

Mansfield, Texas, United States, 76063

Contacts

Study Coordinator

817-415-9664

Southern Star Research Institute ( Site 5000)

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Study Coordinator

210-581-2812

GI Alliance - Southlake ( Site 5109)

Recruiting

Southlake, Texas, United States, 76092-9167

Contacts

Study Coordinator

817-424-1525

Tyler Research Institute ( Site 5001)

Recruiting

Tyler, Texas, United States, 75701

Contacts

Study Coordinator

903-630-6211

Richmond VA Medical Center ( Site 5021)

Recruiting

Richmond, Virginia, United States, 23249

Contacts

Study Coordinator

804-675-5000

University of Washington ( Site 5115)

Recruiting

Seattle, Washington, United States, 98195

Contacts

Study Coordinator

414-805-3000

Washington Gastroenterology - Tacoma ( Site 5004)

Recruiting

Tacoma, Washington, United States, 98405

Contacts

Study Coordinator

253-272-5127

Heritage Medical Research Clinic ( Site 0004)

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

Contacts

Study Coordinator

(403) 220-6014

Gastroenterology and internal medicine research institute ( Site 0009)

Recruiting

Edmonton, Alberta, Canada, T5R 1W2

Contacts

Study Coordinator

780-499-1192

Prairie Institute of Liver and Luminal Advanced Research ( Site 0015)

Recruiting

Lethbridge, Alberta, Canada, T1J 4G9

Contacts

Study Coordinator

403-852-7210

Fraser Clinical Trials Inc ( Site 0001)

Recruiting

New Westminster, British Columbia, Canada, V3L 3W4

Contacts

Study Coordinator

604-521-4500

G.I.R.I. GI Research Institute Foundation ( Site 0018)

Recruiting

Vancouver, British Columbia, Canada, V6Z 2K5

Contacts

Study Coordinator

604-688-6332

Private Practice - Dr. Bruce Musgrave ( Site 0014)

Recruiting

Kentville, Nova Scotia, Canada, B4N 0A3

Contacts

Study Coordinator

902-681-9126

Barrie GI Associates ( Site 0016)

Recruiting

Barrie, Ontario, Canada, L4M 7G1

Contacts

Study Coordinator

705-721-3344

University Hospital - London Health Sciences Centre ( Site 0002)

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Study Coordinator

5196858500x33655

London Health Sciences Centre ( Site 0007)

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Study Coordinator

5196858500 Ex#75554

West GTA Research Inc. ( Site 0020)

Recruiting

Mississauga, Ontario, Canada, L5M 2S4

Contacts

Study Coordinator

905-823-0223

ABP Research Services Corp. ( Site 0019)

Recruiting

Oakville, Ontario, Canada, L6L 5L7

Contacts

Study Coordinator

2898631112

Toronto Immune & Digestive Health Institute ( Site 0005)

Recruiting

Toronto, Ontario, Canada, M6A 3B4

Contacts

Study Coordinator

647-812-2113

Centre de recherche du CISSS de Chaudière-Appalaches - Hôpital Hôtel Dieu de Levis ( Site 0011)

Recruiting

Lévis, Quebec, Canada, G6V 3Z1

Contacts

Study Coordinator

418-835-7121

Centre Hospitalier de l'Université de Montréal - Gastroenterology ( Site 0013)

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Contacts

Study Coordinator

514-890-8000 x11736

Montreal General Hospital ( Site 0003)

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Contacts

Study Coordinator

514-934-1934 #36536

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-21.