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ACTIVE NOT RECRUITING

NCT06052059

PHASE3

A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this protocol is to evaluate the efficacy of tulisokibart in participants with moderately to severely active ulcerative colitis. 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 according to the Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at week 52. 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 according to the Modified Mayo Score at Week 12.

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants With Moderately to Severely Active Ulcerative Colitis

Key Details

Gender

All

Age Range

16 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1020

Start Date

2023-10-25

Completion Date

2029-08-01

Last Updated

2026-03-13

Healthy Volunteers

Conditions

Ulcerative Colitis

Interventions

DRUG

IV Tulisokibart

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

DRUG

IV Placebo

Placebo matching IV tulisokibart

DRUG

SC Tulisokibart

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

DRUG

SC Placebo

Placebo matching SC tulisokibart

Inclusion Criteria: * Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before randomization * Has moderately to severely active UC * Weight ≥40 kg * Satisfies at least 1 of the following criteria: * Has had an inadequate response or loss of response to 1 or more protocol-specified UC treatments * Protocol specified corticosteroid dependence * Has been intolerant to 1 or more protocol-specified UC treatments * Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable * Adolescent participants ≥16 and \<18 years of age can participate if approved by the country or regulatory/health authority * A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding and Is not a participant of childbearing potential (POCBP); or is a POCBP and uses an acceptable contraceptive method, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention, medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy Exclusion Criteria: * Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment. * Has a current diagnosis of fulminant colitis and/or toxic megacolon * Has UC limited to the rectum (i.e, must have evidence of UC extending beyond the rectosigmoid junction, which is \~10 cm from the anal margin) * Has a current or impending need for colostomy or ileostomy * Has had a total proctocolectomy or partial colectomy * Has received fecal microbial transplantation within 4 weeks before randomization * Has had UC exacerbation requiring hospitalization within 2 weeks before screening * Has prior or current evidence of definite colonic dysplasia except for low-grade dysplasia that has been completely removed * Has any active or serious infections without resolution after adequate treatment * Has had cytomegalovirus infection that resolved less than 4 weeks before screening * Has a transplanted organ which requires continued immunosuppression * Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years * Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) * Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidelines), or inadequately treated TB (for participants with history of TB) * Has confirmed or suspected COVID-19 * Has a history of drug or alcohol abuse within 6 months prior to screening * Has had major surgery within 3 months before screening or has a major surgery planned during the study * Is currently receiving or is planning to receive total parenteral nutrition at any time during study treatment * Has received UC-related antibiotics and has not been on stable doses for at least 14 days before randomization or has discontinued these medications within 14 days of randomization * Requires treatment with a therapy that does not adhere to the protocol-specified guidance parameters * Has received protocol-specified prohibited medications * Has had prior exposure to tulisokibart or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody

Locations (476)

Digestive Health Specialists ( Site 0135)

Dothan, Alabama, United States

IMC-Gulf Coast Gastroenterology ( Site 0157)

Fairhope, Alabama, United States

Research Solutions of Arizona ( Site 3816)

Litchfield Park, Arizona, United States

One of a Kind Clinical Research Center ( Site 3852)

Scottsdale, Arizona, United States

GI Alliance - Sun City ( Site 0103)

Sun City, Arizona, United States

Clinnova Research ( Site 3803)

Anaheim, California, United States

Southern California Research Center ( Site 3828)

Coronado, California, United States

UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0113)

La Jolla, California, United States

Cedars-Sinai Medical Center ( Site 0119)

Los Angeles, California, United States

University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3851)

Orange, California, United States

University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 0172)

Aurora, Colorado, United States

Peak Gastroenterology Associates ( Site 0116)

Colorado Springs, Colorado, United States

South Denver Gastroenterology, PC ( Site 3849)

Englewood, Colorado, United States

Rocky Mountain Gastroenterology/Topography Health ( Site 3838)

Littleton, Colorado, United States

Connecticut Clinical Research Institute ( Site 0126)

Bristol, Connecticut, United States

Medical Research Center of Connecticut ( Site 0151)

Hamden, Connecticut, United States

Yale University School of Medicine-Digestive Disease ( Site 0163)

New Haven, Connecticut, United States

Emerson Clinical Research Institute ( Site 3820)

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

Gastroenterology Consultants of Clearwater ( Site 0152)

Clearwater, Florida, United States

University of Florida College of Medicine-Gastroenterology ( Site 3821)

Gainesville, Florida, United States

Nature Coast Clinical Research - Inverness ( Site 3806)

Inverness, Florida, United States

Central Florida Gastro Research ( Site 0124)

Kissimmee, Florida, United States

Research Associates of South Florida - Miami - Southwest 8th Street ( Site 3810)

Miami, Florida, United States

Orlando Health ( Site 0145)

Orlando, Florida, United States

USF Health ( Site 0169)

Tampa, Florida, United States

Emory University School of Medicine ( Site 3818)

Atlanta, Georgia, United States

Atlanta Gastroenterology Associates - Peachtree Dunwoody ( Site 0115)

Atlanta, Georgia, United States

Atlanta Center for Gastroenterology ( Site 0155)

Decatur, Georgia, United States

University of Chicago Medical Center ( Site 0134)

Chicago, Illinois, United States

GI Alliance - Glenview ( Site 0168)

Glenview, Illinois, United States

GI ALLIANCE - GURNEE ( Site 0107)

Gurnee, Illinois, United States

Iowa Digestive Disease Center ( Site 0123)

Clive, Iowa, United States

University of Louisville Hospital-Clinical Trials Unit ( Site 0165)

Louisville, Kentucky, United States

Baton Rouge General Medical Center - Bluebonnet ( Site 0112)

Baton Rouge, Louisiana, United States

Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 0154)

New Orleans, Louisiana, United States

Walter Reed National Military Medical Center ( Site 0121)

Bethesda, Maryland, United States

Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 3835)

Glen Burnie, Maryland, United States

Massachusetts General Hospital-Crohn's and Colitis Center ( Site 0132)

Boston, Massachusetts, United States

University of Michigan ( Site 0143)

Ann Arbor, Michigan, United States

Clinical Research Institute of Michigan, LLC ( Site 0108)

Clinton Township, Michigan, United States

Michigan Center of Medical Research (MICHMER) ( Site 3850)

Farmington Hills, Michigan, United States

Clinical Research Institute of Michigan, LLC ( Site 0150)

Troy, Michigan, United States

Huron Gastroenterology ( Site 3836)

Ypsilanti, Michigan, United States

Mayo Clinic in Rochester, Minnesota ( Site 0147)

Rochester, Minnesota, United States

BVL Research - Kansas ( Site 3847)

Liberty, Missouri, United States

Washington University School of Medicine ( Site 0129)

St Louis, Missouri, United States

Circuit Clinical /Middletown Medical PC ( Site 3831)

Middletown, New York, United States

NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 3846)

New York, New York, United States

Lenox Hill Hospital ( Site 0128)

New York, New York, United States

New York Gastroenterology Associates ( Site 0159)

New York, New York, United States

University of North Carolina Medical Center ( Site 0140)

Chapel Hill, North Carolina, United States

Carolina Digestive Diseases and Endoscopy Center ( Site 3809)

Greenville, North Carolina, United States

Hospital of the University of Pennsylvania ( Site 0170)

Philadelphia, Pennsylvania, United States

University Gastroenterology ( Site 0164)

Providence, Rhode Island, United States

Gastroenterology Associates of Orangeburg ( Site 0149)

Orangeburg, South Carolina, United States

Vanderbilt Inflammatory Bowel Disease Clinic ( Site 0131)

Nashville, Tennessee, United States

Quality Medical Research ( Site 3807)

Nashville, Tennessee, United States

GI Alliance - Garland ( Site 0109)

Garland, Texas, United States

Baylor College of Medicine Medical Center ( Site 3812)

Houston, Texas, United States

The University of Texas Health Science Center at Houston-Internal Medicine-Division of Gastroentero ( Site 0144)

Houston, Texas, United States

Clinical Trial Network ( Site 3819)

Houston, Texas, United States

GI Alliance - Lubbock ( Site 0167)

Lubbock, Texas, United States

Caprock Gastro Research ( Site 0101)

Lubbock, Texas, United States

GI Alliance: Mansfield ( Site 0161)

Mansfield, Texas, United States

CARTA - Clinical Associates In Research Therapeutics Of America ( Site 0122)

San Antonio, Texas, United States

Southern Star Research Institute ( Site 0106)

San Antonio, Texas, United States

GI Alliance - San Marcos ( Site 0130)

San Marcos, Texas, United States

GI Alliance - Southlake ( Site 0104)

Southlake, Texas, United States

Tyler Research Institute ( Site 0105)

Tyler, Texas, United States

Texas Digestive Disease Consultants ( Site 0136)

Webster, Texas, United States

Velocity Clinical Research, Salt Lake City ( Site 3801)

West Jordan, Utah, United States

Richmond VA Medical Center ( Site 3845)

Richmond, Virginia, United States

Washington Gastroenterology - Bellevue ( Site 3844)

Bellevue, Washington, United States

University of Washington Medical Center - Montlake ( Site 0137)

Seattle, Washington, United States

Washington Gastroenterology - Tacoma ( Site 0102)

Tacoma, Washington, United States

Medical College of Wisconsin ( Site 0141)

Milwaukee, Wisconsin, United States

Centro de Investigaciones Médicas Mar del Plata ( Site 2101)

Mar del Plata, Buenos Aires, Argentina

CER medical Institute-Gastroenterology ( Site 2110)

Quilmes, Buenos Aires F.D., Argentina

Hospital Provincial del Centenario ( Site 2108)

Rosario, Santa Fe Province, Argentina

C.I.C.E. 9 de Julio-CICE 9 DE JULIO ( Site 2103)

San Miguel de Tucumán, Tucumán Province, Argentina

Nepean Hospital-Gastroenterology/Hepatology ( Site 2501)

Kingswood, New South Wales, Australia

Concord Repatriation General Hospital-Gastroenterology and Liver Services ( Site 2508)

Sydney, New South Wales, Australia

Royal Brisbane and Women's Hospital ( Site 2500)

Brisbane, Queensland, Australia

Mater Misericordiae Limited-Gastroenterology ( Site 2506)

Brisbane, Queensland, Australia

Royal Adelaide Hospital-Gastroenterology/Hepatology ( Site 2504)

Adelaide, South Australia, Australia

Monash Health-Gastroenterology ( Site 2505)

Clayton, Victoria, Australia

The Alfred Hospital-Gastroenterology ( Site 2503)

Melbourne, Victoria, Australia

St Vincent's Hospital ( Site 2510)

Melbourne, Victoria, Australia

Universitaetsklinik fuer Innere Medizin I Innsbruck ( Site 0200)

Innsbruck, Tyrol, Austria

Medizinische Universität Wien-Klinik für Innere Medizin III - Abteilung für Gastroenterologie und H ( Site 0202)

Vienna, Vienna, Austria

Uniklinikum Salzburg-Innere Medizin I ( Site 0201)

Salzburg, Austria

UZ Gent ( Site 0300)

Ghent, Oost-Vlaanderen, Belgium

UZ Leuven-Gastroenterology - Inflammatory Bowel Disease ( Site 0301)

Leuven, Vlaams-Brabant, Belgium

L2IP - Instituto de Pesquisas Clínicas ( Site 5104)

Brasília, Federal District, Brazil

Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida - Galileo Pesquisa Clínica ( Site 5100)

Juiz de Fora, Minas Gerais, Brazil

Hospital Moinhos de Vento ( Site 5108)

Porto Alegre, Rio Grande do Sul, Brazil

Pesquisare Saude ( Site 5112)

Santo André, São Paulo, Brazil

Centro de Pesquisa Kaiser - CEPEK ( Site 5103)

São José do Rio Preto, São Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 5107)

São José do Rio Preto, São Paulo, Brazil

MC Velingrad 2017 EOOD ( Site 0406)

Velingrad, Pazardzhik, Bulgaria

"Diagnostic - Consultative Center XX - Sofia" EOOD ( Site 0407)

Sofia, Sofia (stolitsa), Bulgaria

Medconsult Pleven ( Site 0410)

Pleven, Bulgaria

DKC V - Plovdiv ( Site 0402)

Plovdiv, Bulgaria

MC Rusemed ( Site 0408)

Rousse, Bulgaria

MHAT Hadzhi Dimitar-Gastroenterology ( Site 0403)

Sliven, Bulgaria

Diagnostic Consultative Center 22 - Sofia ( Site 0401)

Sofia, Bulgaria

4th MHAT ( Site 0409)

Sofia, Bulgaria

Medica Plus Medical Center ( Site 0404)

Veliko Tarnovo, Bulgaria

Heritage Medical Research Clinic ( Site 0004)

Calgary, Alberta, Canada

Gastroenterology and internal medicine research institute ( Site 0010)

Edmonton, Alberta, Canada

Prairie Institute of Liver and Luminal Advanced Research ( Site 0013)

Lethbridge, Alberta, Canada

Fraser Clinical Trials Inc. ( Site 0019)

New Westminster, British Columbia, Canada

G.I.R.I. GI Research Institute Foundation ( Site 0001)

Vancouver, British Columbia, Canada

Private Practice - Dr. Bruce Musgrave ( Site 0011)

Kentville, Nova Scotia, Canada

Barrie GI Associates ( Site 0012)

Barrie, Ontario, Canada

University Hospital - London Health Sciences Centre ( Site 0002)

London, Ontario, Canada

London Health Sciences Centre ( Site 0007)

London, Ontario, Canada

West GTA Research Inc. ( Site 0017)

Mississauga, Ontario, Canada

ABP Research Services Corp. ( Site 0016)

Ontario, Ontario, Canada

Toronto Immune & Digestive Health Institute ( Site 0005)

Toronto, Ontario, Canada

Toronto Digestive Disease Associates ( Site 0006)

Vaughan, Ontario, Canada

Centre Intégré de Santé et Service Sociaux de Chaudière-Appalaches ( Site 0015)

Lévis, Quebec, Canada

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0018)

Montreal, Quebec, Canada

Montreal General Hospital ( Site 0003)

Montreal, Quebec, Canada

Diex Recherche Quebec ( Site 0008)

Québec, Quebec, Canada

Clinical Research Chile SpA ( Site 2201)

Valdivia, Los Ríos Region, Chile

Centro de Estudios Clínicos SAGA-CECSAGA ( Site 2203)