Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD

Part of paid clinical trials in Orlando, Florida.

Sponsor
Alimentiv Inc.
Study ID
NCT06997965
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mirikizumab — DRUG
    Mirikizumab is an IL-23 antagonist.

Study Details

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.

Key Dates

Start date
Apr 20, 2026
Status verified
May 2026
Primary completion
Sep 1, 2027
Completion
Apr 1, 2028

Study Design

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

Arms

  • Other: Mirikizumab
    Open-label mirikizumab 900mg IV Weeks 0,4, and 8 then mirikizumab 300mg SC Weeks 12, 16, 20, and 24.

Primary Outcome Measure

To evaluate the efficacy of mirikizumab in inducing a radiologic response in participants with inflammatory stricturing CD [ Time Frame: At week 24 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Digestive & Liver Center of FloridaOrlandoFlorida32825
Harinath Sheela, Dr
[email protected]
Velocity Clinical- Salt Lake CitySalt Lake CityUtah84088-

Find similar trials in Orlando, FL

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By specialty
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By research site
Digestive & Liver Center of Florida· Orlando, FLVelocity Clinical- Salt Lake City· Salt Lake City, UT

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