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

Phase 3Enrolling By InvitationNCT06540144

UCB Biopharma SRL12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Generalized Myasthenia Gravis

Interventions

rozanolixizumabDRUG

rozanolixizumab solution for injection

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

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 (10)

Mg0008 40290

Bologna, Italy

Mg0008 40144

Milan, Italy

Mg0008 40733

Naples, Italy

Mg0008 20340

Fuchu-shi, Japan

Outcomes

Primary Outcomes

Occurrence of serious Treatment-Emergent Adverse Events (TEAEs) up to the End of Study (EOS) Visit

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

Time frame: From Baseline up to the EOS Visit (up to 52 weeks)

Occurrence of TEAEs leading to permanent withdrawal of IMP up to the EOS Visit

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.

Time frame: From Baseline up to the EOS Visit (up to 52 weeks)

Occurrence of Adverse Event(s) of Special Monitoring (AESM) up to the EOS Visit

AESMs are: Severe and/or serious headache, suspected aseptic meningitis, severe Gastrointestinal (GI) disorders, and opportunistic infection.

Time frame: From Baseline up to the EOS Visit (up to 52 weeks)

Secondary Outcomes

Percent change in total Immunoglobulin G (IgG) from Baseline to the end of Week 6 of each Treatment Period (TP)

Plasma concentration analyses of total IgG will be done for all study participants on an ongoing basis to the end of Week 6 of each TP.

Time frame: From Baseline to the end of Week 6 of each TP (up to 52 weeks)

Data from ClinicalTrials.gov

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