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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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06540144). StuddyBuddy aggregates publicly available trial information.