An Open-label, Single-arm Study Evaluating the Activity, Safety, and Pharmacokinetics of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis
UCB Biopharma SRL
Summary
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).
Eligibility
- Age range
- 2–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Study participant must be ≥2 to \<18 years of age inclusive, at the time of signing the informed consent/assent according to local regulation * Study participant must have a documented diagnosis of generalized Myasthenia Gravis (gMG) at Screening that includes a record confirming the presence of MG specific autoantibodies to acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) prior to Screening * Study participant has Myasthenia Gravis Foundation of America (MGFA) Clinical Classification II to IVa at Screening * Study participant has received existing conventi…
Interventions
- Drugrozanolixizumab
rozanolixizumab solution for injection
Locations (14)
- Mg0006 50574Denton, Texas
- Mg0006 40290Bologna
- Mg0006 40144Milan
- Mg0006 40733Naples
- Mg0006 20340Fuchu-shi
- Mg0006 20339Ōbu