Rozanolixizumab: Rozanolixizumab will be administered by subcutaneous infusion.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Incidence of treatment-emergent adverse events (TEAEs) — Up to 2 years Treatment Emergent Adverse Events (TEAEs) are any untoward medical incidence in a participant after the administration of study treatment, whether or not these events are related to study treatment.
Incidence of treatment-emergent serious adverse events (TESAEs) — Up to 2 years An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed:
* Results in death
* Is life-threatening
* Requires inpatient hospitalization or prolongation of existing hospitalization
* Results in persistent or significant disability/incapacity
* Is a congenital anomaly/birth defect
* Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.
Incidence of TEAEs leading to permanent withdrawal of study treatment — Up to 2 years Treatment Emergent Adverse Events (TEAEs) are any untoward medical incidence in a participant after the administration of study treatment, whether or not these events are related to study treatment. This measure considers any TEAE leading to permanent withdrawal from study.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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