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RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
16 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests tulisokibart (MK-7240) for people with moderate to severe active Crohn’s disease. It compares the drug with a placebo, which has no active medicine, to see if it is safe and helps reduce symptoms and signs of disease inside the bowel.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You were diagnosed with Crohn’s disease at least 3 months before the study.
  • Your Crohn’s disease is moderately to severely active.
  • At least one type of Crohn’s medicine did not work well, stopped working, or caused side effects you could not tolerate. These include steroids and medicines that affect the immune system.
  • Teens ages 16–17 may join if their country or health authority allows it.

Who can't join

  • You have ulcerative colitis or colitis of an unclear type. These are other forms of bowel inflammation.
  • Your Crohn’s affects only the stomach, upper small bowel, or area around the anus, without affecting the colon or last part of the small bowel.
  • You have certain Crohn’s complications, such as a pocket of infection in the belly or near the anus, serious bowel narrowing, severe colon inflammation or swelling, or a problem that may need surgery.
  • You have or need a bowel opening through the belly, are missing more than 2 of 5 listed bowel sections, or had bowel-removal surgery within 3 months.
  • You have short bowel syndrome, another uncontrolled cause of long-term diarrhea, or past or current abnormal cells in the digestive tract that may become cancer.
  • You have had cancer and have been cancer-free for less than 5 years. Exceptions include fully treated non-melanoma skin cancer and very early cervical cancer fully removed by surgery.
  • You have a long-term infection needing ongoing treatment, hepatitis B or C, HIV, active tuberculosis, or confirmed or suspected COVID-19.
  • You have received tulisokibart or another antibody medicine that targets the protein TL1A.

Simplified for readability. The official criteria below are what the study team uses.

Official 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).

Study sites (87)

AL

AR

AZ

CA

CO

CT

DC

FL

GA

IA

IL

IN

KS

KY

LA

MA

MD

MI

MN

MO

NC

NJ

NY

OH

OK

PA

RI

SD

TN

TX

VA

WA