An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis

Sponsor
UCB Biopharma SRL
Study ID
NCT06540144
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Generalized Myasthenia Gravis

Eligibility Criteria

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

Interventions

  • rozanolixizumab — DRUG
    rozanolixizumab solution for injection

Study Details

The purpose of the study is to assess the long term safety and tolerability of additional 6-week treatment cycles with rozanolixizumab in pediatric participants with generalized Myasthenia Gravis (gMG) aged ≥2 at the time of the Screening Visit of MG0006.

Key Dates

First listed
Aug 6, 2024
Start date
Oct 8, 2024
Status verified
Jul 2026
Primary completion
Aug 17, 2027
Completion
Aug 17, 2027

Study Design

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

Arms

  • Experimental: rozanolixizumab
    Study participants will receive pre-defined doses of rozanolixizumab. Each treatment cycle in each Treatment Period (TP) consists of 6 subcutaneous (sc) administrations of rozanolixizumab at 1-week intervals. Each Treatment Period will be initiated upon the discretion of the Investigator based on the medical needs of the study-participant.

Primary Outcome Measure

Occurrence of serious Treatment-Emergent Adverse Events (TEAEs) up to the End of Study (EOS) Visit [ Time Frame: From Baseline up to the EOS Visit (up to 52 weeks) ]

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