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

  • STATUS
    Recruiting
  • End date
    Nov 21, 2022
  • participants needed
    24
  • sponsor
    Ra Pharmaceuticals
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Updated on 21 September 2020
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Investigator
Sponsor: Ra Pharmaceuticals, Inc.
Primary Contact
National Institute of Health (9.7 mi away) Contact
+18 other location

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.

Details
Treatment Placebo, zilucoplan
Clinical Study IdentifierNCT04025632
SponsorRa Pharmaceuticals
Last Modified on21 September 2020

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have Immune Mediated Necrotizing Myopathy?
Clinical diagnosis of IMNM (Immune-Mediated Necrotizing Myopathy)
Positive serology for anti-HMGCR or anti-SRP autoantibodies
Clinical evidence of weakness ( grade 4 out of 5) on manual muscle testing in at least one proximal limb muscle group
CK (creatine kinase) 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 Criteria

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
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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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