Clinical Trials in Italy / NCT06052059
Active, not recruiting
Phase 3
A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)
NCT06052059 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Ulcerative Colitis
Investigational drug(s) / intervention(s)
IV Tulisokibart: Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
IV Placebo: Placebo matching IV tulisokibart
SC Tulisokibart: Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
SC Placebo: Placebo matching SC tulisokibart
Study 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.
Eligibility
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
Primary outcome measure(s)
- Study 1: Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12 — 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 — 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 — 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.
Trial sites (476)
| Facility | City | Region | Status |
|---|---|---|---|
| Digestive Health Specialists ( Site 0135) | Dothan | Alabama | |
| IMC-Gulf Coast Gastroenterology ( Site 0157) | Fairhope | Alabama | |
| Research Solutions of Arizona ( Site 3816) | Litchfield Park | Arizona | |
| One of a Kind Clinical Research Center ( Site 3852) | Scottsdale | Arizona | |
| GI Alliance - Sun City ( Site 0103) | Sun City | Arizona | |
| Clinnova Research ( Site 3803) | Anaheim | California | |
| Southern California Research Center ( Site 3828) | Coronado | California | |
| UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0113) | La Jolla | California | |
| Cedars-Sinai Medical Center ( Site 0119) | Los Angeles | California | |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3851) | Orange | California | |
| University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 0172) | Aurora | Colorado | |
| Peak Gastroenterology Associates ( Site 0116) | Colorado Springs | Colorado | |
| South Denver Gastroenterology, PC ( Site 3849) | Englewood | Colorado | |
| Rocky Mountain Gastroenterology/Topography Health ( Site 3838) | Littleton | Colorado | |
| Connecticut Clinical Research Institute ( Site 0126) | Bristol | Connecticut | |
| Medical Research Center of Connecticut ( Site 0151) | Hamden | Connecticut | |
| Yale University School of Medicine-Digestive Disease ( Site 0163) | New Haven | Connecticut | |
| Emerson Clinical Research Institute ( Site 3820) | Washington D.C. | District of Columbia | |
| Gastroenterology Consultants of Clearwater ( Site 0152) | Clearwater | Florida | |
| University of Florida College of Medicine-Gastroenterology ( Site 3821) | Gainesville | Florida | |
| Nature Coast Clinical Research - Inverness ( Site 3806) | Inverness | Florida | |
| Central Florida Gastro Research ( Site 0124) | Kissimmee | Florida | |
| Research Associates of South Florida - Miami - Southwest 8th Street ( Site 3810) | Miami | Florida | |
| Orlando Health ( Site 0145) | Orlando | Florida | |
| USF Health ( Site 0169) | Tampa | Florida | |
| Emory University School of Medicine ( Site 3818) | Atlanta | Georgia | |
| Atlanta Gastroenterology Associates - Peachtree Dunwoody ( Site 0115) | Atlanta | Georgia | |
| Atlanta Center for Gastroenterology ( Site 0155) | Decatur | Georgia | |
| University of Chicago Medical Center ( Site 0134) | Chicago | Illinois | |
| GI Alliance - Glenview ( Site 0168) | Glenview | Illinois | |
| GI ALLIANCE - GURNEE ( Site 0107) | Gurnee | Illinois | |
| Iowa Digestive Disease Center ( Site 0123) | Clive | Iowa | |
| University of Louisville Hospital-Clinical Trials Unit ( Site 0165) | Louisville | Kentucky | |
| Baton Rouge General Medical Center - Bluebonnet ( Site 0112) | Baton Rouge | Louisiana | |
| Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 0154) | New Orleans | Louisiana | |
| Walter Reed National Military Medical Center ( Site 0121) | Bethesda | Maryland | |
| Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 3835) | Glen Burnie | Maryland | |
| Massachusetts General Hospital-Crohn's and Colitis Center ( Site 0132) | Boston | Massachusetts | |
| University of Michigan ( Site 0143) | Ann Arbor | Michigan | |
| Clinical Research Institute of Michigan, LLC ( Site 0108) | Clinton Township | Michigan |
+ 436 more sites — see the full list on the official registry below.
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06052059 on ClinicalTrials.gov ↗ ← All trials in Italy