RECRUITING

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

Conditions

Ulcerative Colitis Inflammatory Bowel Disease

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-10-25

Study Completion:2029-12-17

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06052059

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Toll Free Number

CONTACT

1-888-577-8839

Trialsites@msd.com

Principal Investigator

Medical Director

STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Locations (Sites)

Digestive Health Specialists ( Site 0135)

Dothan, Alabama, 36301

United States

IMC-Gulf Coast Gastroenterology ( Site 0157)

Fairhope, Alabama, 36532

United States

Research Solutions of Arizona ( Site 3816)

Litchfield Park, Arizona, 85340

United States

GI Alliance - Sun City ( Site 0103)

Sun City, Arizona, 85351

United States

Southern California Research Center ( Site 3828)

Coronado, California, 92118

United States

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

La Jolla, California, 92037

United States

Clinnova Research - Orange ( Site 3803)

Orange, California, 92868

United States

University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 01

Aurora, Colorado, 80045

United States

Peak Gastroenterology Associates ( Site 0116)

Colorado Springs, Colorado, 80907

United States

Rocky Mountain Gastroenterology/Topography Health ( Site 3838)

Littleton, Colorado, 80120

United States

Connecticut Clinical Research Institute ( Site 0126)

Bristol, Connecticut, 06010

United States

Medical Research Center of Connecticut ( Site 0151)

Hamden, Connecticut, 06518

United States

Emerson Clinical Research Institute ( Site 3820)

Washington, District of Columbia, 20009

United States

Gastroenterology Consultants of Clearwater ( Site 0152)

Clearwater, Florida, 33756

United States

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

Gainesville, Florida, 32610

United States

Nature Coast Clinical Research - Inverness ( Site 3806)

Inverness, Florida, 34452

United States

Kissimmee Surgery Center (endoscopy) ( Site 0124)

Kissimmee, Florida, 34741

United States

Orlando Health ( Site 0145)

Orlando, Florida, 32806

United States

Emory University School of Medicine ( Site 3818)

Atlanta, Georgia, 30322

United States

Atlanta Gastroenterology Associates - Peachtree Dunwoody ( Site 0115)

Atlanta, Georgia, 30342

United States

Atlanta Center for Gastroenterology ( Site 0155)

Decatur, Georgia, 30033

United States

GI Alliance - Glenview ( Site 0168)

Glenview, Illinois, 60026

United States

GI ALLIANCE - GURNEE ( Site 0107)

Gurnee, Illinois, 60031

United States

Iowa Digestive Disease Center ( Site 0123)

Clive, Iowa, 50325

United States

Baton Rouge General Medical Center - Bluebonnet ( Site 0112)

Baton Rouge, Louisiana, 70809

United States

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

New Orleans, Louisiana, 70112

United States

Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 3835)

Glen Burnie, Maryland, 21061

United States

University of Michigan ( Site 0143)

Ann Arbor, Michigan, 48109

United States

Clinical Research Institute of Michigan, LLC ( Site 0108)

Clinton Township, Michigan, 48038

United States

Clinical Research Institute of Michigan, LLC ( Site 0150)

Troy, Michigan, 48098

United States

Huron Gastroenterology ( Site 3836)

Ypsilanti, Michigan, 48197

United States

BVL Research - Kansas ( Site 3847)

Liberty, Missouri, 64068

United States

Washington University School of Medicine ( Site 0129)

Saint Louis, Missouri, 63110

United States

Circuit Clinical /Middletown Medical PC ( Site 3831)

Middletown, New York, 10940

United States

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

New York, New York, 10016

United States

Lenox Hill Hospital ( Site 0128)

New York, New York, 10075

United States

New York Gastroenterology Associates ( Site 0159)

New York, New York, 10128

United States

Carolina Digestive Diseases and Endoscopy Center ( Site 3809)

Greenville, North Carolina, 27834

United States

Hospital of the University of Pennsylvania ( Site 0170)

Philadelphia, Pennsylvania, 19104

United States

University Gastroenterology ( Site 0164)

Providence, Rhode Island, 02904

United States

Gastroenterology Associates of Orangeburg ( Site 0149)

Orangeburg, South Carolina, 29118

United States

Vanderbilt Inflammatory Bowel Disease Clinic ( Site 0131)

Nashville, Tennessee, 37204

United States

Quality Medical Research ( Site 3807)

Nashville, Tennessee, 37211

United States

GI Alliance - Garland ( Site 0109)

Garland, Texas, 75044

United States

The University of Texas Health Science Center at Houston-Internal Medicine-Division of Gastroentero

Houston, Texas, 77030

United States

Clinical Trial Network ( Site 3819)

Houston, Texas, 77074

United States

GI Alliance - Lubbock ( Site 0167)

Lubbock, Texas, 79410

United States

Caprock Gastro Research ( Site 0101)

Lubbock, Texas, 79424

United States

GI Alliance: Mansfield ( Site 0161)

Mansfield, Texas, 76063

United States

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

San Antonio, Texas, 78212

United States

Southern Star Research Institute ( Site 0106)

San Antonio, Texas, 78229

United States

GI Alliance - San Marcos ( Site 0130)

San Marcos, Texas, 78666

United States

GI Alliance - Southlake ( Site 0104)

Southlake, Texas, 76092-9167

United States

Tyler Research Institute ( Site 0105)

Tyler, Texas, 75701

United States

Texas Digestive Disease Consultants ( Site 0136)

Webster, Texas, 77598

United States

Velocity Clinical Research, Salt Lake City ( Site 3801)

West Jordan, Utah, 84088

United States

Washington Gastroenterology - Bellevue ( Site 3844)

Bellevue, Washington, 98004-4631

United States

Washington Gastroenterology - Tacoma ( Site 0102)

Tacoma, Washington, 98405

United States

MEDICAL COLLEGE OF WISCONSIN ( Site 0141)

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-25

Study Completion Date2029-12-17

Study Record Updates

Study Start Date2023-10-25

Study Completion Date2029-12-17

Terms related to this study

Keywords Provided by Researchers

Inflammatory Bowel Disease

Additional Relevant MeSH Terms

Ulcerative Colitis