ACTIVE_NOT_RECRUITING

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

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Conditions

Ulcerative ColitisInflammatory Bowel Disease

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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:2029-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_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 CriteriaExclusion Criteria
  1. * Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before randomization
  2. * Has moderately to severely active UC
  3. * Weight ≥40 kg
  4. * Satisfies at least 1 of the following criteria:
  5. * Has had an inadequate response or loss of response to 1 or more protocol-specified UC treatments
  6. * Protocol specified corticosteroid dependence
  7. * Has been intolerant to 1 or more protocol-specified UC treatments
  8. * Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable
  9. * Adolescent participants ≥16 and \<18 years of age can participate if approved by the country or regulatory/health authority
  10. * 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
  1. * 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.
  2. * Has a current diagnosis of fulminant colitis and/or toxic megacolon
  3. * 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)
  4. * Has a current or impending need for colostomy or ileostomy
  5. * Has had a total proctocolectomy or partial colectomy
  6. * Has received fecal microbial transplantation within 4 weeks before randomization
  7. * Has had UC exacerbation requiring hospitalization within 2 weeks before screening
  8. * Has prior or current evidence of definite colonic dysplasia except for low-grade dysplasia that has been completely removed
  9. * Has any active or serious infections without resolution after adequate treatment
  10. * Has had cytomegalovirus infection that resolved less than 4 weeks before screening
  11. * Has a transplanted organ which requires continued immunosuppression
  12. * 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
  13. * Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
  14. * Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidelines), or inadequately treated TB (for participants with history of TB)
  15. * Has confirmed or suspected COVID-19
  16. * Has a history of drug or alcohol abuse within 6 months prior to screening
  17. * Has had major surgery within 3 months before screening or has a major surgery planned during the study
  18. * Is currently receiving or is planning to receive total parenteral nutrition at any time during study treatment
  19. * 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
  20. * Requires treatment with a therapy that does not adhere to the protocol-specified guidance parameters
  21. * Has received protocol-specified prohibited medications
  22. * Has had prior exposure to tulisokibart or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody

Contacts and Locations

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
One of a Kind Clinical Research Center ( Site 3852)
Scottsdale, Arizona, 85258
United States
GI Alliance - Sun City ( Site 0103)
Sun City, Arizona, 85351
United States
Clinnova Research ( Site 3803)
Anaheim, California, 92805
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
Cedars-Sinai Medical Center ( Site 0119)
Los Angeles, California, 90048
United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3851)
Orange, California, 92868
United States
University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 0172)
Aurora, Colorado, 80045
United States
Peak Gastroenterology Associates ( Site 0116)
Colorado Springs, Colorado, 80907
United States
South Denver Gastroenterology, PC ( Site 3849)
Englewood, Colorado, 80113
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
Yale University School of Medicine-Digestive Disease ( Site 0163)
New Haven, Connecticut, 06510
United States
Emerson Clinical Research Institute ( Site 3820)
Washington D.C., 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
Central Florida Gastro Research ( Site 0124)
Kissimmee, Florida, 34741
United States
Research Associates of South Florida - Miami - Southwest 8th Street ( Site 3810)
Miami, Florida, 33134
United States
Orlando Health ( Site 0145)
Orlando, Florida, 32806
United States
USF Health ( Site 0169)
Tampa, Florida, 33612
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
University of Chicago Medical Center ( Site 0134)
Chicago, Illinois, 60637
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
University of Louisville Hospital-Clinical Trials Unit ( Site 0165)
Louisville, Kentucky, 40202
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
Walter Reed National Military Medical Center ( Site 0121)
Bethesda, Maryland, 20889
United States
Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 3835)
Glen Burnie, Maryland, 21061
United States
Massachusetts General Hospital-Crohn's and Colitis Center ( Site 0132)
Boston, Massachusetts, 02114
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
Michigan Center of Medical Research (MICHMER) ( Site 3850)
Farmington Hills, Michigan, 48334
United States
Clinical Research Institute of Michigan, LLC ( Site 0150)
Troy, Michigan, 48098
United States
Huron Gastroenterology ( Site 3836)
Ypsilanti, Michigan, 48197
United States
Mayo Clinic in Rochester, Minnesota ( Site 0147)
Rochester, Minnesota, 55905
United States
BVL Research - Kansas ( Site 3847)
Liberty, Missouri, 64068
United States
Washington University School of Medicine ( Site 0129)
St 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
University of North Carolina Medical Center ( Site 0140)
Chapel Hill, North Carolina, 27514
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
Baylor College of Medicine Medical Center ( Site 3812)
Houston, Texas, 77030
United States
The University of Texas Health Science Center at Houston-Internal Medicine-Division of Gastroentero ( Site 0144)
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
Richmond VA Medical Center ( Site 3845)
Richmond, Virginia, 23249
United States
Washington Gastroenterology - Bellevue ( Site 3844)
Bellevue, Washington, 98004-4631
United States
University of Washington Medical Center - Montlake ( Site 0137)
Seattle, Washington, 98195
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 Date2029-08-01

Study Record Updates

Study Start Date2023-10-25
Study Completion Date2029-08-01

Terms related to this study

Keywords Provided by Researchers

  • Inflammatory Bowel Disease

Additional Relevant MeSH Terms

  • Ulcerative Colitis