A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)
- 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.
- Short title
- A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2029-08-01
- First posted
- 2023-09-25
- Registry last updated
- 2026-03-13
- Primary completion date
- 2026-08-01
- Start date
- 2023-10-25
- Participants
- 1,020
- Participant count basis
- Estimated
- Planned participants
- 1,020
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Merck Sharp & Dohme LLC
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06052059
- ClinicalTrials.gov ID
- NCT06052059
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masking description
- Induction and maintenance treatments will be blinded. Reinduction will not be blinded.
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Study 1: Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12
Timeframe: Week 12
The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Study 1: Percentage of Participants Achieving Clinical Remission Per MMS at Week 52
Timeframe: Week 52
The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Study 2: Percentage of Participants Achieving Clinical Remission Per MMS at Week 12
Timeframe: Week 12
The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Study 1: Percentage of Participants With One or More Adverse Events (AEs)
Timeframe: Up to approximately 52 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE will be reported.
Study 1: Percentage of Participants Who Discontinued Study Intervention Due to an AE
Timeframe: Up to approximately 52 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Study 1: Percentage of Participants Achieving Clinical Response Per Partial Modified Mayo Score (pMMS) at Week 2
Timeframe: Week 2
The partial Modified Mayo Score (pMMS) is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as pMMS reduction of 1 or more points and 30% or more, plus a reduction of 1 or more points in RBS or an absolute RBS of 0 or 1.
Study 1: Percentage of Participants With Endoscopic Improvement at Week 12
Timeframe: Week 12
Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Study 1: Percentage of Participants Achieving a Clinical Response Per MMS at Week 12
Timeframe: Week 12
The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as an MMS reduction of 2 or more points and 30% or more, plus a reduction of more than 1 point in RBS or an absolute RBS of 0 or 1.
Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement (HEMI) at Week 12
Timeframe: Week 12
HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Study 1: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 12
Timeframe: Week 12
pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of ≤1.
Study 1: Percentage of Participants With Endoscopic Remission at Week 12
Timeframe: Week 12
ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). Endoscopic remission is defined as an ES of 0.
Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 12
Timeframe: Week 12
Bowel urgency is measured using an NRS, which rates bowel urgency on a 0-11 scale of increasing severity. Resolution is defined as a score of 0 or 1 in participants who had a baseline score of 3 or more.
Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 12
Timeframe: Week 12
Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0.
Study 1: Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12
Timeframe: Week 12
The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224. IBDQ remission is defined as a score of at least 170.
Study 1: Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12
Timeframe: Baseline and Week 12
The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0-52 point scale, with greater scores indicating a better fatigue-related quality of life. The change from baseline in FACIT-Fatigue score will be presented.
Percentage of Diagnostic Assay Positive (Dx+) Participants Achieving Clinical Remission Per MMS at Week 12
Timeframe: Week 12
Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Percentage of Dx+ Participants With Endoscopic Improvement at Week 12
Timeframe: Week 12
Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Study 1: Percentage of Participants Achieving Histologic-Endoscopic Remission (HER) at Week 12
Timeframe: Week 12
HER is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Study 1: Percentage of Participants with Endoscopic Improvement at Week 52
Timeframe: Week 52
Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission Per MMS at Week 52
Timeframe: Week 52
The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Corticosteroid-free clinical remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS, and no corticosteroid use for ≥90 days before Week 52.
Study 1: Percentage of Participants Achieving HEMI at Week 52
Timeframe: Week 52
HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Study 1: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 52
Timeframe: Week 52
pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of ≤1.
Study 1: Percentage of Participants Achieving Sustained Clinical Remission Per MMS at Both Week 12 and Week 52
Timeframe: Week 12 and Week 52
The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Sustained clinical remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS, at both Week 12 and Week 52.
Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 52
Timeframe: Week 52
Bowel urgency is measured using an NRS, which rates bowel urgency on a 0-11 scale of increasing severity. Resolution is defined as a score of 0 or 1 in participants who had a baseline score of 3 or more.
Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 52
Timeframe: Week 52
Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0.
Study 1: Percentage of Participants With Endoscopic Remission at Week 52
Timeframe: Week 52
ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). Endoscopic remission is defined as an ES of 0.
Study 1: Percentage of Participants with Sustained Endoscopic Improvement at Both Week 12 and Week 52
Timeframe: Week 12 and Week 52
Sustained endoscopic improvement is defined as an ES of 0 or 1 at both Week 12 and Week 52. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Study 1: Percentage of Participants Achieving HER at Week 52
Timeframe: Week 52
HER is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
And 17 more, listed on the interactive page.
- Sex
- All
- Age groups
- Children, Adults, Older adults
- Minimum age
- 16 Years
- Maximum age
- 80 Years
- Healthy volunteers
- No
-
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
- Digestive Health Specialists ( Site 0135)Dothan, United States
- IMC-Gulf Coast Gastroenterology ( Site 0157)Fairhope, United States
- Research Solutions of Arizona ( Site 3816)Litchfield Park, United States
- One of a Kind Clinical Research Center ( Site 3852)Scottsdale, United States
- GI Alliance - Sun City ( Site 0103)Sun City, United States
- Clinnova Research ( Site 3803)Anaheim, United States
- Southern California Research Center ( Site 3828)Coronado, United States
- UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0113)La Jolla, United States
- Cedars-Sinai Medical Center ( Site 0119)Los Angeles, United States
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3851)Orange, United States
- University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 0172)Aurora, United States
- Peak Gastroenterology Associates ( Site 0116)Colorado Springs, United States
- South Denver Gastroenterology, PC ( Site 3849)Englewood, United States
- Rocky Mountain Gastroenterology/Topography Health ( Site 3838)Littleton, United States
- Connecticut Clinical Research Institute ( Site 0126)Bristol, United States
- Medical Research Center of Connecticut ( Site 0151)Hamden, United States
- Yale University School of Medicine-Digestive Disease ( Site 0163)New Haven, United States
- Emerson Clinical Research Institute ( Site 3820)Washington D.C., United States
- Gastroenterology Consultants of Clearwater ( Site 0152)Clearwater, United States
- University of Florida College of Medicine-Gastroenterology ( Site 3821)Gainesville, United States
- Nature Coast Clinical Research - Inverness ( Site 3806)Inverness, United States
- Central Florida Gastro Research ( Site 0124)Kissimmee, United States
- Research Associates of South Florida - Miami - Southwest 8th Street ( Site 3810)Miami, United States
- Orlando Health ( Site 0145)Orlando, United States
- USF Health ( Site 0169)Tampa, United States
And 451 more, listed on the interactive page.
- Related resource (www.merckclinicaltrials.com)
- 2023
- U1111-1296-0203
- jRCT2031230563
- 2023-507473-17-00
- PR200-301
Related records
Drugs (1)
Collaborators (1)
- PPD, Part of Thermo Fisher Scientific
Lead sponsors (1)
Conditions (2)
- Inflammatory bowel disease
- Ulcerative colitis Primary condition