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Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch

NCT06864403 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-01-30

No results posted yet for this study

Summary

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

Conditions

  • Pouchitis
  • Pouches, Ileoanal
  • Pouch, Ileal

Interventions

DRUG

Mirikizumab - Subcutaneous (SC)

Pre-filled syringes administered at Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52.

DRUG

Mirikizumab - Intravenous (IV)

300 mg mirikizumab at Weeks 0, 4, and 8

Sponsors & Collaborators

Principal Investigators

  • Edward Barnes, MD, MPH · University of North Carolina

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-12
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06864403 on ClinicalTrials.gov