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

UCB

Status and phase: Not yet enrolling; Phase 3

Conditions: Ocular Myasthenia Gravis

Treatments: Drug: Rozanolixizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07465289

MG0039

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Rozanolixizumab

Experimental group

Description:

The study is composed of Extended Observation Period(s) and Symptom-driven Cycle(s). Based on their clinical need for treatment, study participants will be able to start the study with either an Extended Observation Period or a Symptom-driven Cycle. A Symptom-driven Cycle will be initiated based on disease worsening and participants will receive rozanolixizumab based on investigator's medical judgement.

Treatment:

Drug: Rozanolixizumab