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

UCB

Status and phase: Invitation-only; Phase 3

Conditions: Generalized Myasthenia Gravis

Treatments: Drug: rozanolixizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06540144

MG0008

2022-502075-34 (Registry Identifier)

U1111-1286-3581 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

rozanolixizumab

Experimental group

Description:

Study participants will receive pre-defined doses of rozanolixizumab. Each treatment cycle in each Treatment Period (TP) consists of 6 subcutaneous (sc) administrations of rozanolixizumab at 1-week intervals. Each Treatment Period will be initiated upon the discretion of the Investigator based on the medical needs of the study-participant.

Treatment:

Drug: rozanolixizumab