A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis

Part of paid clinical trials in Columbus, Ohio.

Sponsor
UCB Biopharma SRL
Study ID
NCT07465289
Phase
PHASE3
Status
Recruiting
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Conditions

  • Ocular Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rozanolixizumab — DRUG
    Rozanolixizumab will be administered by subcutaneous infusion.

Study Details

The purpose of the study is to assess the long-term safety and efficacy of rozanolixizumab in adult study participants with ocular myasthenia gravis.

Key Dates

First listed
Mar 11, 2026
Start date
Sep 16, 2026
Status verified
Oct 2026
Primary completion
Jan 23, 2031
Completion
Jan 23, 2031

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rozanolixizumab
    The study is composed of Extended Observation Period(s) and Symptom-driven Cycle(s). Based on their clinical need for treatment, study participants will be able to start the study with either an Extended Observation Period or a Symptom-driven Cycle. A Symptom-driven Cycle will be initiated based on disease worsening and participants will receive rozanolixizumab based on investigator's medical judgement.

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mg0039 10103ColumbusOhio43210-

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