Summary

for people ages 18-85 (full criteria)
at Orange, California and other locations
study started
estimated completion

Description

Summary

The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with generalized Myasthenia Gravis (gMG). Subjects will be randomized in a 1:1:1 ratio to receive daily SC doses of 0.1 mg/kg RA101495, 0.3 mg/kg RA101495, or matching placebo for 12 weeks.

Official Title

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of RA101495 in Subjects With Generalized Myasthenia Gravis

Keywords

Generalized Myasthenia Gravis Muscle Weakness Myasthenia Gravis zilucoplan (RA101495)

Eligibility

You can join if…

Open to people ages 18-85

  • Diagnosis of gMG [Myasthenia Gravis Foundation of America (MGFA) Class II-IVa] at Screening
  • Positive serology for acetylcholine receptor (AChR) autoantibodies
  • QMG score ≥ 12 at Screening and Randomization
  • No change in corticosteroid dose for at least 30 days prior to Randomization or anticipated to occur during the 12-week Treatment Period
  • No change in immunosuppressive therapy, including dose, for at least 30 days prior to Randomization or anticipated to occur during the 12-week Treatment Period

You CAN'T join if...

  • Thymectomy within 6 months prior to Randomization or scheduled to occur during the 12 week Treatment Period
  • History of meningococcal disease
  • Current or recent systemic infection within 2 weeks prior to Randomization or infection requiring intravenous (IV) antibiotics within 4 weeks prior to Randomization

Locations

  • University of California Irvine Health ALS and Neuromuscular Center
    Orange California 92868 United States
  • UCLA Medical Center
    Los Angeles California 90095 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ra Pharmaceuticals
ID
NCT03315130
Phase
Phase 2
Study Type
Interventional
Last Updated