An Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to Crohn's Disease
Alimentiv Inc.
Summary
This is an open-label, single-arm, phase 4 study to assess the safety and efficacy of mirikizumab in approximately 60 participants with stricturing CD.
Description
This is an open-label, single-arm, phase 4 study to assess the safety and efficacy of mirikizumab in approximately 60 participants with stricturing CD. This study will enroll adults (≥18 years of age) with a diagnosis of ileal or ileocolonic CD based upon radiologic, clinical, endoscopic, and histologic evidence with tolerable obstructive stricture symptoms. Participants will be recruited from approximately 15 sites in 2 countries (United States and Canada). This study consists of 3 study periods (screening period, open-label treatment period, and safety follow-up). After signing informed con…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Nonpregnant, nonlactating adults, ≥ 18 years of age. 2. Diagnosis of ileal or ileocolonic CD based on standard clinical, endoscopic, and histologic evidence; established at least 3 months prior to screening. 3. Presence of at least 1 inflammatory stricture in the terminal ileum\* within reach of an endoscope (passable or nonpassable). Strictures should be noncritical, naïve or anastomotic stricture(s), caused by CD and confirmed centrally by MRE according to the following criteria: * Localized luminal narrowing (luminal diameter ≤ 50% relative to normal adjacent bow…
Interventions
- DrugMirikizumab
Mirikizumab is an IL-23 antagonist.
Locations (2)
- Digestive & Liver Center of FloridaOrlando, Florida
- Velocity Clinical- Salt Lake CitySalt Lake City, Utah