A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUCB Biopharma SRL

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

Treatment groups

100 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators