Recruiting NCT06430801

A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)

Phase III Interventional Crohn's Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: IV Tulisokibart, SC Tulisokibart, IV Placebo, SC Placebo.
Who it may be relevant to: Registry conditions: Crohn's Disease. Basic parameters: 16 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Austria, Belgium, Brazil +42
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease

Overview

The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. 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 Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). 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 Crohn's Disease Activity Index score (\<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).

Detailed description

The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.

Interventions

Drug IV Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
Drug SC Tulisokibart
Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
Other IV Placebo
Placebo matching IV tulisokibart
Other SC Placebo
Placebo matching SC tulisokibart

Primary outcome measures

Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52 [Time frame: Week 52]
Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52 [Time frame: Week 52]
Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52 [Time frame: Week 52]
Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12 [Time frame: Week 12]
Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12 [Time frame: Week 12]
Study 1: Percentage of Participants Achieving Endoscopic Response at Week 12 [Time frame: Week 12]
Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12 [Time frame: Week 12]
Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12 [Time frame: Week 12]
Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12 [Time frame: Week 12]

Secondary outcome measures (12)

Study 1: Number of Participants Who Experienced an Adverse Event (AE) [Time frame: Up to approximately 52 weeks]
Study 1: Number of Participants Who Discontinue Study Intervention due to an AE [Time frame: Up to approximately 52 weeks]
Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12 [Time frame: Week 12]
Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12 [Time frame: Week 12]
Study 1: Percentage of Participants With Clinical Response per CDAI Score (Decrease From Baseline of ≥100 Points) at Week 12 [Time frame: Week 12]
Study 1: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12 [Time frame: Baseline and Week 12]
Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 12 [Time frame: Week 12]
Study 1 and 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Clinical Remission per CDAI Score at Week 12 [Time frame: Week 12]
Study 1 and 2: Percentage of Participants in Dx+ Subpopulation Achieving Endoscopic Response at Week 12 [Time frame: Week 12]
Study 1: Percentage of Participants With Clinical Response (Decrease From Baseline at Least 100 Points) or Clinical Remission (<150) per CDAI Score at Week 6 [Time frame: Week 6]
Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52 [Time frame: Week 52]
Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 52 [Time frame: Week 52]

Eligibility criteria

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion criteria

Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.
Has moderately to severely active CD.
Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.
Adolescent participants ≥16 and <18 years of age can participate if approved by the country or regulatory/health authority.

Exclusion criteria

Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
Has current stoma or need for colostomy or ileostomy.
Is missing >2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD.
Has surgical bowel resection within 3 months of study.
Has prior or current gastrointestinal dysplasia.
Has chronic infection requiring ongoing antimicrobial treatment.
Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years.
Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
Has active tuberculosis.
Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.
Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment