MG0039

A Phase 3, Open-Label, Extension Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis

Brief summary

The purpose of the study is to assess the long-term safety and efficacy of rozanolixizumab in adult study participants with ocular myasthenia gravis.

Medical Condition

Ocular Myasthenia Gravis

Min. Age

18
Years

Max. Age

-

Who Can Join?

All

Status

Not yet recruiting
Inclusion criteria
- 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 - Male or female - A female participant is eligible to participate if she is not, not breastfeeding (including pumping breastmilk to feed a child), and at least 1 of the following conditions applies: ◦ Not a woman of childbearing potential (WOCBP) ◦ OR ◦ A WOCBP who agrees to follow the contraceptive guidance for the entire study period - Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol
Exclusion criteria
- 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 - Participant has planned use of prohibited medications

Study Medication Description

Study Medication:

RYSTIGGO

Other Descriptive Name:

rozanolixizumab

Placebo

No

Comparator:

No

Study Dates

September 2026

Planned Start Date of Enrollment

January 2031

Planned Study Completion Date

General Information

Study ID:
MG0039
CT.gov Number:
NCT07465289
Phase:
Phase 3

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