A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis (roMyG)

UCB

Status and phase

Enrolling

Phase 3

Phase 2

Conditions

Generalized Myasthenia Gravis

Treatments

Drug: rozanolixizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT06149559

MG0006

U1111-1285-0787 (Other Identifier)

2022-502074-16-00 (Registry Identifier)

Details and patient eligibility

About

The purpose of the study is to assess the safety and tolerability of subcutaneous (sc) administration of rozanolixizumab in pediatric participants aged ≥2 to <18 years with generalized Myasthenia Gravis (gMG).

Enrollment

12 estimated patients

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Study participant must be ≥2 to <18 years of age inclusive, at the time of signing the informed consent/assent according to local regulation
Study participant must have a documented diagnosis of generalized Myasthenia Gravis (gMG) at Screening that includes a record confirming the presence of MG specific autoantibodies to acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) prior to Screening
Study participant has Myasthenia Gravis Foundation of America (MGFA) Clinical Classification II to IVa at Screening
Study participant has received existing conventional treatment(s) for gMG (eg, pyridostigmine, corticosteroids, and/or immune suppressants) prior to Screening
Study participant has had an unsatisfactory clinical response or worsening of gMG symptoms and is in need of additional therapy (for example, plasma exchange (PEX) or treatment with intravenous immunoglobulin (IVIg))

Exclusion criteria

Study participant with severe weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis at Screening or Baseline
Study participant has a known hypersensitivity to any components of the Investigational Medicinal Product (IMP) or other anti-neonatal-Fc receptor (FcRn) medications
Study participant with any active or untreated thymoma
Study participant has a history of thymectomy within 6 months prior to Screening
Study participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess) in the opinion of the Investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of IMP
Study participant has received a live vaccination within 4 weeks prior to Baseline or intends to have a live vaccination during the course of the study