Status:
TERMINATED
Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy
Lead Sponsor:
Ra Pharmaceuticals
Conditions:
Immune Mediated Necrotizing Myopathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- Clinical diagnosis of IMNM (Immune-Mediated Necrotizing Myopathy)
- Positive serology for anti-3-hydroxy-3-methyl-glutaryl-coenzyme A reductase (HMGCR) or anti-signal recognition particle (SRP) autoantibodies
- Clinical evidence of weakness (≤ grade 4 out of 5) on manual muscle testing in at least one proximal limb muscle group
- Creatine kinase (CK) of \>1000 U/L at Screening
- No change in corticosteroid dose for at least 30 days prior to Baseline or anticipated to occur during the first 8-weeks on study
- No changes in immunosuppressive therapy, including dose, for at least 30 days prior to Baseline or anticipated to occur during the first 8-weeks on study
Exclusion
- History of meningococcal disease
- Current or recent systemic infection within 2 weeks prior to Screening or infection requiring intravenous (IV) antibiotics within 4 weeks prior to Screening
- Recent initiation of intravenous immunoglobulin (IVIG) (i.e., first cycle administered less than 90 days prior to Baseline)
- Rituximab use within 90 days prior to Baseline or anticipated to occur during study
- Statin use within 30 days prior to Baseline or anticipated to occur during study
- Plasma exchange within 4 weeks prior to Baseline or expected to occur during the 8-week Treatment Period
Key Trial Info
Start Date :
November 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2021
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04025632
Start Date
November 7 2019
End Date
June 14 2021
Last Update
July 27 2022
Active Locations (18)
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1
University of California Los Angeles
Los Angeles, California, United States, 90095
2
University of California Irvine
Orange, California, United States, 92868
3
University of Florida Health Jacksonville
Jacksonville, Florida, United States, 32209
4
University of South Florida
Tampa, Florida, United States, 33612