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
- Bochum, Essen, Goettingen, Jena, Leipzig, Rüdersdorf, and Wuerzburg, GermanySee the 7 sites
- Phase
- Phase 3
Where in Germany
- Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil gGmbHBochum, GermanyNot yet recruiting
- Universitaetsklinikum Essen (AoR)Essen, GermanyNot yet recruiting
- Universitaetsmedizin GoettingenGoettingen, GermanyNot yet recruiting
- Universitaetsklinikum Jena KöRJena, GermanyNot yet recruiting
- Universitaet LeipzigLeipzig, GermanyNot yet recruiting
- Immanuel Klinik RuedersdorfRüdersdorf, GermanyNot yet recruiting
- Universitaetsklinikum Wuerzburg AöRWuerzburg, GermanyNot 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.