A Phase 3, Open-Label, Extension Study to Evaluate The Long-Term Safety And Efficacy of rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
An open-label, extension study to evaluate the long-term safety and efficacy of rozanolixizumabin study participants with oMG
Ikeda Kaori
UCB Japan Co., Ltd.
8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo, 160-0023
+81-3-6864-7500
CTR-JRCT.UCBJapan@ucb.com
Global Clinical Science & Operation
UCB Japan Co., Ltd.
8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo
+81-3-6864-7500
CTR_SCC_UCBJapan@UCB.com
Recruiting
Dec. 21, 2026
12
Interventional
non-randomized controlled trial
open(masking not used)
uncontrolled control
single assignment
treatment purpose
- 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 judgment of the investigator.
- Male or female.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding (including pumping breast milk 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.
- 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 prohibited immunosuppressive medications, biologics, or other therapies.
- Participant has planned use of prohibited medications.
18age old over
No limit
Both
Ocular Myasthenia Gravis
Experimental: rozanolixizumab
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.
- Incidence of treatment-emergent adverse events (TEAEs).
- Incidence of treatment-emergent serious adverse events (TESAEs).
- Incidence of TEAEs leading to permanent withdrawal of study treatment.
- Change from Baseline at Day 43 in Myasthenia Gravis Impairment Index (MGII) ocular score (Patient-Reported Outcome part).
- Change from Baseline at Day 43 in Myasthenia Gravis Activities of Daily Living (MG-ADL) ocular score.
- Change from Baseline at Day 43 in Myasthenia Gravis Symptoms Patient-Reported Outcome (MGSPRO) ocular muscle weakness scale score.
- Change from Baseline at Day 43 in Myasthenia Gravis Quality of Life 15-Item Scale (Revised Version) (MG-QoL15r) total score.
- Proportion of study participants who progress to Myasthenia Gravis Foundation of America (MGFA) Class >= 2 over time.
- Change from Baseline in MGII total score and generalized score over time.
- Change from Baseline in MG-ADL total score over time.
UCB Japan Co., Ltd.
Kobe University Hospital Institutional Review Board
8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo, 160-0023, Hyogo
