About this trial
The purpose of the study is to assess the long-term safety and efficacy of rozanolixizumab in adult study participants with ocular myasthenia gravis.
Eligibility criteria
Qualifiers
Participant must be a minimum of 18 years of age inclusive at the time of signing the informed consent form (ICF)
Participant must have received at least 1 dose of investigational medicinal product (IMP) (rozanolixizumab or placebo) in MG0038
Participant for whom the investigator considers a favorable benefit/risk for participation
Participant who, alone or with assistance of the caregiver, is considered reliable and capable of adhering to the protocol visit schedule or medication intake according to the judgement of the investigator
Disqualifiers
Participant meets any of the withdrawal criteria defined in MG0038
Participant has a clinically relevant active infection (resulting in hospitalization or requiring intravenous (IV) antibiotic treatment) within 6 weeks before study entry.
Participant intends to have a live vaccination during the study or within 8 weeks following the final dose of rozanolixizumab
Participant has been administered with the prohibited immunosuppressive medications, biologics, or other therapies
Trial design
Treatments tested in this trial
- Rozanolixizumab