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

NCT06540144

Enrolling By InvitationPhase 3

Sponsor: UCB Biopharma SRL

Conditions: Generalized Myasthenia Gravis

Interventions: rozanolixizumab

Countries: Italy, Japan, Poland, Taiwan, Turkey (Türkiye)

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 overview

Sex: ALL

Age: 2 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (11)

Bologna, Italy
Milan, Italy
Naples, Italy
Fuchu-shi, Japan
Ōbu, Japan
Sagamihara, Japan
Lodz, Poland
Warsaw, Poland
Taipei, Taiwan
Taipei, Taiwan
Yenimahalle, Turkey (Türkiye)