Etrasimod as Prevention of Pouchitis

Part of paid clinical trials in New York, New York.

Sponsor
Maia Kayal
Study ID
NCT07486921
Phase
PHASE2
Status
Recruiting
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Conditions

  • Pouchitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • etrasimod — DRUG
    2 mg once daily for 48 weeks
  • Placebo — DRUG
    matching placebo for 48 weeks

Study Details

The researchers propose conducting a multi-center, randomized, placebo-controlled study to investigate the potential role of etrasimod for the primary and secondary prevention of pouchitis among high-risk patients submitted to total proctocolectomy (TPC) with ileal-pouch anal anastomosis (IPAA) for medically refractory disease. The trial will be conducted in compliance with this protocol, Good Clinical Practice guidelines, and Institutional Review Board requirements.

Key Dates

Start date
Jun 12, 2026
Status verified
Jun 2026
Primary completion
Feb 6, 2030
Completion
Feb 6, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: etrasimod
    study drug etrasimod 2 mg once daily for 48 weeks
  • Placebo Comparator: Placebo
    Placebo for 48 weeks

Primary Outcome Measure

Proportion of participants with at least 1 episode of acute pouchitis [ Time Frame: 48 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School Of Medicine at Mount SinaiNew YorkNew York10029
Maia Kayal
[email protected]
212-241-8100
Sari Feldman
[email protected]
212-241-8100
Maia Kayal (PRINCIPAL_INVESTIGATOR)

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Icahn School Of Medicine at Mount Sinai· New York, NY

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