A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
A Phase 3, Open-Label, Extension Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
- Ocular Myasthenia Gravis
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- UCB Biopharma SRL
- Enrolment target
- 100
- Started
- 16 September 2026
- Main results due
- 23 January 2031
- Study sites
- 7
- Registry updated
- 24 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
The purpose of the study is to assess the long-term safety and efficacy of rozanolixizumab in adult study participants with ocular myasthenia gravis.
Study sites(7)
Mg0039 10103
Columbus, Ohio, United States
Recruiting
Mg0039 31901
Beijing, China
Recruiting
Mg0039 31907
Nanchang, China
Recruiting
Mg0039 31902
Suzhou, China
Recruiting
Mg0039 31802
Kobe, Japan
Recruiting
Mg0039 20604
Barcelona, Spain
Recruiting
Mg0039 20611
Madrid, Spain
Recruiting
Showing 7 of 7 sites. 7 of the 7 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07465289. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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