At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 68 enrolled
Drug / intervention
M281 +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, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis
In Brief
A Phase 2 clinical trial evaluating M281 and Placebo for Generalized Myasthenia Gravis. Completed, enrolled 68 participants across 61 sites in 8 countries.
Detailed Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of M281 administered to participants with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing standard of care therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGeneralized Myasthenia Gravis
CountriesBelgium, Canada, Germany, Italy, Poland, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartApr 2019
Primary CompletionJun 2020
TodayJul 2026
First PostedDec 11, 2018
Enrollment StartApr 10, 2019
Primary CompletionJun 25, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.6 years ago
Interventions
M281drug
M281 administered as IV infusion
Placeboother
Placebo administered as intravenous (IV) infusion