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Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy

NCT04025632 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2022-07-27

Study results available
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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

  • Immune Mediated Necrotizing Myopathy

Interventions

DRUG

zilucoplan

Daily subcutaneous (SC) inection

OTHER

Placebo

Daily subcutaneous (SC) inection

Sponsors & Collaborators

  • Ra Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • UCB Cares · UCB Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-07
Primary Completion
2021-03-04
Completion
2021-06-14
FDA Drug
Yes

Countries

  • United States
  • France
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04025632 on ClinicalTrials.gov