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)
| NCT ID | NCT06430801 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Merck Sharp & Dohme LLC |
| Condition | Crohn's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2024-06-05 |
| Primary Completion | 2028-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,200 participants in total. It began in 2024-06-05 with a primary completion date of 2028-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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).
Contact & Investigator
Medical Director
STUDY DIRECTOR
Merck Sharp & Dohme LLC
Frequently Asked Questions
Who can join the NCT06430801 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 80 Years, studying Crohn's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06430801 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,200 participants.
Is NCT06430801 currently recruiting?
Yes, NCT06430801 is actively recruiting participants. Contact the research team at Trialsites@msd.com for enrollment information.
Where is the NCT06430801 trial being conducted?
This trial is being conducted at Dothan, United States, Phoenix, United States, Sun City, United States, Tucson, United States and 11 additional locations.
Who is sponsoring the NCT06430801 clinical trial?
NCT06430801 is sponsored by Merck Sharp & Dohme LLC. The principal investigator is Medical Director at Merck Sharp & Dohme LLC. The trial plans to enroll 1,200 participants.
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