A clinical study of MK-7240 for the treatment of Crohn’s disease (MK-7240-008)
Key facts
- Where
- Bekescsaba, Budapest, Budapest III, Budapest VI, Budapest XIII, Eger, Gyongyos, Tatabánya és Veszprem, MagyarországSee the 9 sites
- Phase
- 3. fázis
Where in Magyarország
- Bekes Varmegyei Koezponti KorhazBekescsaba, MagyarországTaking people
- Semmelweis UniversityBudapest, MagyarországTaking people
- Clinexpert Kft.Budapest III, MagyarországTaking people
- Central Hospital Of Northern Pest Military HospitalBudapest VI, MagyarországTaking people
- Pannonia Maganorvosi Centrum Kft.Budapest XIII, MagyarországTaking people
- Heves Varmegyei Markhot Ferenc Oktatokorhaz Es RendelointezetEger, MagyarországTaking people
- Gyoengyosi Bugat Pal KoerhazGyongyos, MagyarországTaking people
- Komarom-Esztergom Varmegyei Szent Borbala KorhazTatabánya, MagyarországTaking people
- VeszLife Kft.Veszprem, MagyarországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- EU 2024-518296-56-00
- Record updated
- 2026. november 10.
- Original description
1.Study 2: US/FDA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per Crohn’s Disease Activity Index score (<150) at Week 12 2.Study 2: EU/EMA: Evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per stool frequency and abdominal pain score at Week 12 3.Study 2: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving endoscopic response at Week 12Read full original descriptionShow less
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
1.Study 2: US/FDA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per Crohn’s Disease Activity Index score (<150) at Week 12 2.Study 2: EU/EMA: Evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per stool frequency and abdominal pain score at Week 12 3.Study 2: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving endoscopic response at Week 12
Inclusion: 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: Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab); 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 surgical bowel resection within 3 months of study; Has prior or current gastrointestinal dysplasia; 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; Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD; 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; 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; 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.