A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis

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

Study Details

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.

Key Dates

Start date

May 27, 2026

Status verified

Jun 2026

Primary completion

Dec 1, 2028

Completion

Jan 22, 2029

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Rozanolixizumab
  After the Screening Period, participants will enter the study Intervention Period and will be administered study drug for up to 6 weeks. Prior to entering the Intervention Period, study participants will be randomized at a 1:1 ratio and will receive rozanolixizumab. At the End of Treatment Visit, participants will enter an Observation Period of 4 to 7 weeks with an opportunity to transition to an open-label extension study.
• Placebo Comparator: Placebo
  After the Screening Period, participants will enter the study Intervention Period and will be administered study drug for up to 6 weeks. Prior to entering the Intervention Period, study participants will be randomized at a 1:1 ratio and will receive placebo. At the End of Treatment Visit, participants will enter an Observation Period of 4 to 7 weeks with an opportunity to transition to an open-label extension study.

Primary Outcome Measure

Change from Baseline at Day 43 in (Myasthenia Gravis Impairment Index) MGII ocular score (Patient-Reported Outcome (PRO) part) [ Time Frame: At Day 43 ]

Central Contacts

• UCB Cares
  +18445992273
  [email protected]
• UCB Cares
  00184459922733 (UCB)
  [email protected]

Locations (2)

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