Phase 4 Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis

Sponsor
UCB Biopharma SRL
Study ID
NCT07246564
Phase
PHASE4
Status
Recruiting
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Conditions

  • Myasthenia Gravis

Eligibility Criteria

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

Interventions

  • Rozanolixizumab — DRUG
    Subcutaneous infusion

Study Details

The purpose of the study is to assess the clinical efficacy of rozanolixizumab in adult Chinese participants with generalized myasthenia gravis (gMG) in the first Treatment Cycle.

Key Dates

First listed
Nov 24, 2025
Start date
Dec 1, 2025
Status verified
May 2026
Primary completion
Oct 15, 2027
Completion
Oct 15, 2027

Study Design

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

Arms

  • Experimental: Rozanolixizumab
    Participants will receive 6 dose per cycle of subcutaneous infusion of rozanolixizumab

Primary Outcome Measure

Change from Baseline to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score in the first Treatment Cycle [ Time Frame: Baseline to Day 43 (in first treatment cycle) ]

Central Contacts

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