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Enrolling By Invitation
NCT06540144
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
Conditions: Generalized Myasthenia Gravis
Sex: All
Ages: 2 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 12
Sponsor: UCB Biopharma SRL
Location: Mg0008 40290 Bologna
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 Criteria
Inclusion Criteria:
Study participant must meet one of the following:
* Study participant completed MG0006 according to the protocol
* Study participant completed the MG0006 Treatment Period and has a worsening of generalized myasthenia gravis (gMG) symptoms in the Observation Period of MG0006
Exclusion Criteria:
* Study participant met any mandatory withdrawal or mandatory permanent investigational medicinal product (IMP) discontinuation criteria in MG0006 or permanently discontinued IMP
* Study participant has a known hypersensitivity to any components of the IMP or other neonatal Fc receptor (FcRn) drugs
* Study participant has any laboratory abnormality that, in the opinion of the Investigator, is clinically significant, has not resolved at Baseline, and could jeopardize or compromise the study participant's ability to participate in this study
Source: ClinicalTrials.gov (NCT06540144). StuddyBuddy aggregates publicly available trial information.