A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
UCB Biopharma SRL
Summary
The purpose of the study is to demonstrate the efficacy, safety and tolerability of rozanolixizumab compared with placebo in the treatment of adult study participants with Ocular Myasthenia Gravis.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant must be a minimum of 18 years of age inclusive at the time of signing the informed consent form (ICF) * Participant has Myasthenia Gravis Foundation of America (MGFA) Class I with any ocular weakness at Screening through Baseline. The participant may have weakness in muscles of eye (ie, extraocular muscles that move the eyeball, including the medial rectus, lateral rectus, superior rectus, inferior rectus, superior oblique, and inferior oblique, orbicularis oculi muscles, and levator palpebrae superioris) but must have normal strength in all other facial, bul…
Interventions
- DrugRozanolixizumab
Rozanolixizumab will be administered by subcutaneous infusion.
- DrugPlacebo
Placebo will be administered by subcutaneous infusion.
Locations (2)
- Mg0038 10106Amherst, New York
- Mg0038 10103Columbus, Ohio