Not yet recruiting NCT07465289
A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rozanolixizumab.
- Who it may be relevant to
- Registry conditions: Ocular Myasthenia Gravis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3, Open-Label, Extension Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Overview
The purpose of the study is to assess the long-term safety and efficacy of rozanolixizumab in adult study participants with ocular myasthenia gravis.
Interventions
- Drug Rozanolixizumab
Rozanolixizumab will be administered by subcutaneous infusion.
Primary outcome measures
- Incidence of treatment-emergent adverse events (TEAEs) [Time frame: Up to 2 years]
- Incidence of treatment-emergent serious adverse events (TESAEs) [Time frame: Up to 2 years]
- Incidence of TEAEs leading to permanent withdrawal of study treatment [Time frame: Up to 2 years]
Secondary outcome measures (7)
- Change from Baseline at Day 43 in (Myasthenia Gravis Impairment Index) MGII ocular score (Patient-Reported Outcome part) [Time frame: At Day 43 (of the first 3 Symptom-driven Cycles)]
- Change from Baseline at Day 43 in Myasthenia Gravis Activities of Daily Living (MG-ADL) ocular score [Time frame: At Day 43 (of the first 3 Symptom-driven Cycles)]
- Change from Baseline at Day 43 in Myasthenia Gravis Symptoms Patient-Reported Outcome (MGSPRO) ocular muscle weakness scale score [Time frame: At Day 43 (of the first 3 Symptom-driven Cycles)]
- Change from Baseline at Day 43 in Myasthenia Gravis Quality of Life 15-item Scale (revised version) (MG-QoL15r) total score [Time frame: At Day 43 (of the first 3 Symptom-driven Cycles)]
- Study participant who generalizes to Myasthenia Gravis Foundation of America (MGFA) class ≥2 over time [Time frame: Up to 2 years]
- Change from Baseline in MGII total and generalized score over time [Time frame: Up to 2 years]
- Change from Baseline in MG-ADL total score over time [Time frame: Up to 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07465289 · MG0039