Trials / Terminated
TerminatedNCT04025632
Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Ra Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the safety and efficacy of zilucoplan in patients with Immune-Mediated Necrotizing Myopathy (IMNM). Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or matching placebo for 8 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | zilucoplan | Daily subcutaneous (SC) inection |
| OTHER | Placebo | Daily subcutaneous (SC) inection |
Timeline
- Start date
- 2019-11-07
- Primary completion
- 2021-03-04
- Completion
- 2021-06-14
- First posted
- 2019-07-19
- Last updated
- 2022-07-27
- Results posted
- 2022-05-16
Locations
18 sites across 4 countries: United States, France, Netherlands, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04025632. Inclusion in this directory is not an endorsement.