Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ra Pharmaceuticals
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy
