At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 71 enrolled
Drug / intervention
Rozanolixizumabdrug
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 Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
In Brief
A Phase 3 clinical trial evaluating Rozanolixizumab for Generalized Myasthenia Gravis. Completed, enrolled 71 participants across 43 sites in 12 countries.
Detailed Summary
The purpose of the MycarinGstudy is to evaluate the long-term safety, tolerability and long-term efficacy of rozanolixizumab in study participants with generalized myasthenia gravis (MG).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGeneralized Myasthenia Gravis
CountriesCanada, Czechia, Denmark, France, Germany, Italy, Japan, Poland, Russia, Spain, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedOct 2019
Enrollment StartOct 2019
Primary CompletionSep 2021
TodayJul 2026
First PostedOct 14, 2019
Enrollment StartOct 29, 2019
Primary CompletionSep 1, 2021
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.7 years ago
Interventions
Rozanolixizumabdrug
Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.