NCT03315130

Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Ra Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Generalized Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	zilucoplan (RA101495)	Daily subcutaneous (SC) injection
DRUG	Placebo	Daily subcutaneous (SC) injection

Timeline

• Start date: 2017-10-11
• Primary completion: 2018-12-10
• Completion: 2020-11-19
• First posted: 2017-10-19
• Last updated: 2022-07-27
• Results posted: 2022-06-27

Locations

30 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study