NCT06430801 · Merck Sharp & Dohme LLC
A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
What this study is about
The purpose of this protocol is to evaluate the effectiveness and safety of tulisokibart in participants with moderately to severely active Crohn's disease.
View original scientific description
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease.
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
The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 1 will be presented.
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
The percentage of participants achieving clinical remission per stool frequency/abdominal pain score (SF/APS), as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 1 will be presented.
Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52
Time frame: Week 52
The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in Simplified endoscopic score for Crohn's disease (SES-CD) from baseline for study 1 will be presented.
Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
Time frame: Week 12
The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 1 will be presented.
Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
Time frame: Week 12
The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 1 will be presented.
Study 1: Percentage of Participants Achieving Endoscopic Response at Week 12
Time frame: Week 12
The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in SES-CD from baseline for study 1 will be presented.
Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
Time frame: Week 12
The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 2 will be presented.
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
The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 2 will be presented.
Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12
Time frame: Week 12
The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in SES-CD from baseline for study 2 will be presented.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Exclusion criteria
- include but are not limited to the following: Inclusion Criteria:
- Has had a diagnosis of 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,
Where
- Dothan, Alabama
- Phoenix, Arizona
- Sun City, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Anaheim, California
- Coronado, California
- Lancaster, California
- Los Angeles, California
- Orange, California
- Oxnard, California
- San Diego, California
And 63 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations