At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 200 enrolled
Drug / intervention
Rozanolixizumab +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 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
In Brief
A Phase 3 clinical trial evaluating Rozanolixizumab and Placebo for Generalized Myasthenia Gravis. Completed, enrolled 200 participants across 112 sites in 17 countries.
Detailed Summary
The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (MG).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGeneralized Myasthenia Gravis
CountriesBelgium, Canada, Czechia, Denmark, France, Georgia, Germany, Hungary, Italy, Japan, Poland, Russia, Serbia, Spain, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedJun 2019
Enrollment StartJun 2019
Primary CompletionAug 2021
Study CompletionOct 2021
TodayJul 2026
First PostedJun 3, 2019
Enrollment StartJun 3, 2019
Primary CompletionAug 31, 2021
Study CompletionOct 26, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7.1 years ago
Interventions
Rozanolixizumabdrug
Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.
Placeboother
Subjects will receive placebo at pre-specified time points.