An open-label, extension study Safety, efficacy of rozanolixizumab in study participants with oMG
Research type
Research Study
Full 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.
IRAS ID
1013911
Contact name
Britanny Harvey
Contact email
Sponsor organisation
UCB Biopharma SRL,
Eudract number
2025-524757-14
Clinicaltrials.gov Identifier
Research summary
The MG0038 clinical study is a Phase 3, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of rozanolixizumab in adult participants with ocular myasthenia gravis (oMG). The objective of the study is to determine whether rozanolixizumab can improve ocular symptoms—specifically ptosis and diplopia—as well as improve the overall impact of the disease impact rozanolixizumab can improve ocular symptoms—specifically ptosis and diplopia—as well as improve the overall impact of the disease impact in adults diagnosed with oMG. The study population includes adults aged 18 years or older diagnosed with MGFA Class I (ocular) myasthenia gravis, while the intervention consists of rozanolixizumab or placebo administered as weekly subcutaneous infusions for six weeks using an infusion pump, with dosing based on body weight tiers aligned to the approved generalized myasthenia gravis labeling in each respective region.
The study duration comprises a screening period of up to six weeks, a six week treatment period, and a four to seven week observation period, resulting in a total participation time of up to nineteen weeks. Participants are randomized in a 1:1 ratio, stratified according to antibody status (AChR/MuSK positive versus seronegative), corticosteroid use, and geographic region, and following completion of the End of Study visit, they may be offered the option to transition into an Open Label Extension (OLE) study.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
26/YH/0110
Date of REC Opinion
13 Jul 2026
REC opinion
Further Information Favourable Opinion