At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 165 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.
An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
In Brief
A Phase 3 clinical trial evaluating Rozanolixizumab for Generalized Myasthenia Gravis. Completed, enrolled 165 participants across 69 sites in 14 countries.
Detailed Summary
The purpose of this study is to assess the safety, tolerability and efficacy of additional 6-week treatment cycles with rozanolixizumab in study participants with generalized myasthenia gravis (gMG).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGeneralized Myasthenia Gravis
CountriesCanada, Czechia, Denmark, France, Georgia, Germany, Italy, Japan, Poland, Russia, Serbia, Spain, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedDec 2020
Enrollment StartFeb 2021
Primary CompletionJan 2024
TodayJul 2026
First PostedDec 3, 2020
Enrollment StartFeb 3, 2021
Primary CompletionJan 25, 2024
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 5.6 years ago
Interventions
Rozanolixizumabdrug
Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.