Study

Overview

Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Induction and Maintenance Study to Evaluate the Efficacy and Safety of PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis

The purpose of this protocol is to evaluate the efficacy and safety 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 per 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 per 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 per Modified Mayo Score at Week 12.

Study Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

1020

Study Start Date:

October 2023

Estimated Study Completion Date:

December 2029

Estimated Primary Completion Date:

November 2026

Eligibility

Ages Eligible for Study:

16 years to 75 years

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

CRITERIA

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
Participant assigned male sex at birth, if capable of producing sperm, agrees to abstain from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent; or uses prescribed contraception unless azoospermic
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 been hospitalized for the treatment of UC within 2 weeks before screening
Has prior or current evidence of definite low-grade or high-grade colonic dysplasia including dysplasia identified during the Screening colonoscopy that has not been completely removed
Has any active or serious infections without resolution after adequate treatment
Has had a herpes zoster reactivation or cytomegalovirus that resolved less than 8 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 infection
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 (i.e, requiring general anesthesia) 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

United States Toll Free Number 1-800-770-4674

Dothan, Alabama, 36301
Litchfield Park, Arizona, 85340
Sun City, Arizona, 85351
Colorado Springs, Colorado, 80907
Clearwater, Florida, 33756
Inverness, Florida, 34452
Atlanta, Georgia, 30342
Decatur, Georgia, 30033
Glenview, Illinois, 60026
Gurnee, Illinois, 60031
Clive, Iowa, 50325
Baton Rouge, Louisiana, 70809
Ann Arbor, Michigan, 48109
Chesterfield, Michigan, 48047
Troy, Michigan, 48098
Middletown, New York, 10940
New York, New York, 10128
Greenville, North Carolina, 27834
Nashville, Tennessee, 37211
Garland, Texas, 75044
Houston, Texas, 77074
Lubbock, Texas, 79410
Mansfield, Texas, 76063
San Antonio, Texas, 78212
San Antonio, Texas, 78229
San Marcos, Texas, 78666
Southlake, Texas, 76092-9167
Tyler, Texas, 75701
Webster, Texas, 77598
West Jordan, Utah, 84088
Tacoma, Washington, 98405

Results

No Study Results Posted

Plain Language Summaries

Protocols

Protocol Plain Language Summary - MK-7240-001

Study Detail

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