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

Condition(s) studied

Investigational drug(s) / intervention(s)

rozanolixizumab: rozanolixizumab solution for injection

Study summary

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.

Eligibility

Primary outcome measure(s)

• Occurrence of serious Treatment-Emergent Adverse Events (TEAEs) up to the End of Study (EOS) Visit — From Baseline up to the EOS Visit (up to 52 weeks)
  Serious TEAEs are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment and additionally are emergent untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalisation or prolongation of existing hospitalisation * Results in persistent disability/incapacity * Is a congenital anomaly or birth defect * Important medical events
• Occurrence of TEAEs leading to permanent withdrawal of IMP up to the EOS Visit — From Baseline up to the EOS Visit (up to 52 weeks)
  An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
• Occurrence of Adverse Event(s) of Special Monitoring (AESM) up to the EOS Visit — From Baseline up to the EOS Visit (up to 52 weeks)
  AESMs are: Severe and/or serious headache, suspected aseptic meningitis, severe Gastrointestinal (GI) disorders, and opportunistic infection.

Trial sites (11)

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