At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 45 enrolled
Drug / intervention
zilucoplan (RA101495) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating zilucoplan (RA101495) and Placebo for Generalized Myasthenia Gravis. Completed, enrolled 45 participants across 30 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGeneralized Myasthenia Gravis
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartOct 2017
First PostedOct 2017
Primary CompletionDec 2018
Study CompletionNov 2020
TodayJul 2026
First PostedOct 19, 2017
Enrollment StartOct 11, 2017
Primary CompletionDec 10, 2018
Study CompletionNov 19, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.7 years ago
Interventions
zilucoplan (RA101495)drug
Daily subcutaneous (SC) injection
Placebodrug
Daily subcutaneous (SC) injection