Long-term study of rozanolixizumab in adults with ocular myasthenia gravis
Tests rozanolixizumab over the long term in adults with ocular myasthenia gravis.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Key facts
- Where
- Bergamo, Florence, Messina, Milan, Naples, Pavia, Pisa, and Rome, ItalySee the 8 sites
- Phase
- Phase 3
Where in Italy
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyNot yet recruiting
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyNot yet recruiting
- Azienda Ospedaliera Universitaria Gaetano Martino MessinaMessina, ItalyNot yet recruiting
- IRCCS Foundation Istituto Neurologico Carlo BestaMilan, ItalyNot yet recruiting
- Azienda Ospedaliera di Rilievo Nazionale Antonio CardarelliNaples, ItalyNot yet recruiting
- Fondazione Istituto Neurologico Nazionale Casimiro MondinoPavia, ItalyNot yet recruiting
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyNot yet recruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UCB Biopharma SRL
- Trial code
- NCT07465289EU 2025-524757-14-00
- Record updated
- 6 November 2026
- Original description
The purpose of the study is to assess the long-term safety and efficacy of rozanolixizumab in adult study participants with ocular myasthenia gravis.Read full original descriptionShow less
A Phase 3, Open-Label, Extension Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
The purpose of the study is to assess the long-term safety and efficacy of rozanolixizumab in adult study participants with ocular myasthenia gravis.
Inclusion: 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: Participant has a clinically relevant active infection (resulting in hospitalization or requiring intravenous (IV) antibiotic treatment) within 6 weeks before study entry; Participant has been administered with the prohibited immunosuppressive medications, biologics, or other therapies; Participant has planned use of prohibited medications; Participant meets any of the withdrawal criteria defined in MG0038; Participant intends to have a live vaccination during the study or within 8 weeks following the final dose of rozanolixizumab.