Trial intelligence / Profile preview

Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis

NCT07465289Phase 3

Key facts

Status
Recruiting
Start
Sep 2026
Primary completion
Mar 2031
Countries
4
Sponsor
UCB
Modality
Monoclonal Antibodies
Conditions
myasthenia gravis (MG)
01

Overview

Phase 3, open-label, single-arm trial of rozanolixizumab in myasthenia gravis (MG), sponsored by UCB. Primary endpoints: Incidence of treatment-emergent adverse events up to 2 years, Incidence of treatment-emergent serious adverse events up to 2 years and 1 more. Started Sep 2026; status: recruiting.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Rozanolixizumab

    Participants receive rozanolixizumab based on investigator's medical judgement during Symptom-driven Cycles.

03

Who it enrols

Adults with ocular myasthenia gravis who participated in the MG0038 study and received at least one dose of rozanolixizumab or placebo.

04

Endpoints

Primary

  • Incidence of treatment-emergent adverse events

  • Incidence of treatment-emergent serious adverse events

  • Incidence of TEAEs leading to permanent withdrawal of study treatment

Secondary

  • Change from Baseline in Myasthenia Gravis Impairment Index ocular score

  • Change from Baseline in Myasthenia Gravis Activities of Daily Living ocular score

  • Change from Baseline in Myasthenia Gravis Symptoms Patient-Reported Outcome ocular muscle weakness scale score

  • Change from Baseline in Myasthenia Gravis Quality of Life 15-item Scale (revised version) total score

  • Study participant who generalizes to Myasthenia Gravis Foundation of America class >=2 over time

  • Change from Baseline in MGII total and generalized score over time

  • Change from Baseline in MG-ADL total score over time

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