Trials / Withdrawn
WithdrawnNCT04305678
Mepolizumab for Eosinophilic Fasciitis
Mepolizumab for the Treatment of Eosinophilic Fasciitis; An Open-Label, Single-Arm, Exploration Study
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a proof of concept pilot study to investigate the efficacy of mepolizumab in the treatment of eosinophilic fasciitis.
Detailed description
This is an exploratory study designed to generate preliminary data in evaluating the efficacy of mepolizumab (Nucala) in the treatment of EF using mean change in the Rodnan Skin score (mRSS) before and after treatment. The study is powered at 90% to detect a 4 point change in the mRSS at a 5% significant level with a minimum target accrual of 6 patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mepolizumab | Mepolizumab (Nucala) 400 mg SC every 4 weeks x 24 weeks |
Timeline
- Start date
- 2023-02-01
- Primary completion
- 2023-02-15
- Completion
- 2023-02-15
- First posted
- 2020-03-12
- Last updated
- 2024-11-20
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04305678. Inclusion in this directory is not an endorsement.