Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06864403
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Pouch, Ileal
  • Pouches, Ileoanal
  • Pouchitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Mirikizumab - Intravenous (IV) — DRUG
    300 mg mirikizumab at Weeks 0, 4, and 8
  • Mirikizumab - Subcutaneous (SC) — DRUG
    Pre-filled syringes administered at Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52.

Study Details

The goal of this clinical trial is to learn if mirikizumab works to treat pouch disorders in adults. The main questions it aims to answer are: Does mirikizumab reduce symptoms of pouch disorders Participants will: Take mirikizumab every 4 weeks for one year Visit the clinic once every month for two months and at the end of the study Keep a diary of their symptoms

Key Dates

Start date
Aug 12, 2025
Status verified
Sep 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: All patients
    Open Label Mirikizumab

Primary Outcome Measure

Remission as measured by Modified Pouchitis Disease Activity Index (mPDAI) [ Time Frame: Weeks 0, 24, and 52 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
UCLA Vatche & Tamar Manoukian Division of Digestive DiseasesLos AngelesCalifornia90024
Xiaoxiao Yin
[email protected]
310-206-3778
Gaurav Syal, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Chad Rypstra
[email protected]
507-538-4289
Laura Raffals (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Nathasha Melukkaran
[email protected]
646-754-3417
Shannon Chang, MD, MBA (PRINCIPAL_INVESTIGATOR)
University of North CarolinaChapel HillNorth Carolina27599-7080
Emily English
[email protected]
919-843-8105
Edward Barnes, MD, MPH (PRINCIPAL_INVESTIGATOR)
Allegheny Health NetworkPittsburghPennsylvania15212
Brianna Smith
[email protected]
412-228-8310
Gursimran Kochhar (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
UCLA Vatche & Tamar Manoukian Division of Digestive Diseases· Los Angeles, CAMayo Clinic· Rochester, MNNYU Langone Health· New York, NYUniversity of North Carolina· Chapel Hill, NCAllegheny Health Network· Pittsburgh, PA

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