Phase 3 Program to Evaluate MK-7240 for Moderate to Severe Ulcerative Colitis

JRCT ID: jRCT2031230563

Registered date:12/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ulcerative Colitis
• Date of first enrollment: 27/03/2024
• Target sample size: 1020
• Countries of recruitment: United States,Japan,Canada,Japan,Chile,Japan,Colombia,Japan,Argentina,Japan,Mexico,Japan,France,Japan,Germany,Japan,Italy,Japan,Poland,Japan,Serbia,Japan,Switzerland,Japan,Austria,Japan,Belgium,Japan,Bulgaria,Japan,Croatia,Japan,Czech Republic,Japan,Hungary,Japan,Israel,Japan,Netherlands,Japan,Portugal,Japan,Romania,Japan,Slovakia,Japan,South Africa,Japan,Spain,Japan,Turkey,Japan,UK,Japan,Australia,Japan,New Zealand,Japan,South Korea,Japan
• Study type: Interventional

Intervention(s)

Study 1 Group 1: High dose induction (intravenous [IV] infusion), High dose maintenance (subctaneous [SC])
Study 1 Group 2: High dose induction (IV infusion), Low dose maintenance (SC)
Study 1 Group 3: Low dose induction (IV infusion), Low dose maintenance (SC)
Study 1 Group 4: Placebo induction (IV infusion), Placebo maintenance (SC)
Study 1 Extension: High dose or Low dose extension (SC)
Study 2 Group 1: High dose induction (IV infusion)
Study 2 Group 2: Low dose induction (IV infusion)
Study 2 Group 3: Placebo induction (IV infusion)
Study 2 Extension: High dose or Low dose extension (SC)

Outcome(s)

Primary Outcome

- Study 1, 2: Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12
- Study 1: Percentage of Participants Achieving Clinical Remission Per MMS at Week 52
- Study 1, 2: Percentage of Participants With One or More Adverse Events (AEs)
- Study 1, 2: Percentage of Participants Who Discontinued Study Intervention Due to an AE

Secondary Outcome

Following outcome will be evaluated at Week 12 and/or Week 52, or Week 2:
Clinical Response per Partial Modified Mayo Score (pMMS), Endoscopic Improvement, Clinical Response per MMS, Histologic-Endoscopic Mucosal Improvement (HEMI),Clinical Remission per pMMS, Endoscopic Remission, No Bowel Urgency, No Abdominal Pain, Inflammatory Bowel Disease Questionnaire (IBDQ) Remission, Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score, Histologic-Endoscopic Remission (HER), Corticosteroid-Free Clinical Remission per MMS, Sustained Clinical Remission per MMS, Sustained Clinical Response per MMS, Sustained Endoscopic Improvement

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

- Has 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 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

Exclude 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 MK-7240 or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody

Related Information

• Primary Sponsor: Tanaka Yoshiyuki
• Secondary ID(s): NCT06052059