A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis

Part of paid clinical trials in Denton, Texas.

Sponsor
UCB Biopharma SRL
Study ID
NCT06149559
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Generalized Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • rozanolixizumab — DRUG
    rozanolixizumab solution for injection

Study Details

The purpose of the study is to assess the safety and tolerability of subcutaneous (sc) administration of rozanolixizumab in pediatric participants aged ≥2 to \<18 years with generalized Myasthenia Gravis (gMG).

Key Dates

Start date
Jun 14, 2024
Status verified
May 2026
Primary completion
Jun 8, 2026
Completion
Aug 17, 2026

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 for 6 weeks.

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 18 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mg0006 50574DentonTexas76208-

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Mg0006 50574· Denton, TX

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