An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: rozanolixizumab.
- Who it may be relevant to
- Registry conditions: Generalized Myasthenia Gravis. Basic parameters: from 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy, Japan, Poland, Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-label Extension Study to Evaluate Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
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.
Interventions
- Drug rozanolixizumab
rozanolixizumab solution for injection
Primary outcome measures
- Occurrence of serious Treatment-Emergent Adverse Events (TEAEs) up to the End of Study (EOS) Visit [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 [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 [Time frame: From Baseline up to the EOS Visit (up to 52 weeks)]
Secondary outcome measures (4)
- Percent change in total Immunoglobulin G (IgG) from Baseline to the end of Week 6 of each Treatment Period (TP) [Time frame: From Baseline to the end of Week 6 of each TP (up to 52 weeks)]
- Absolute change in total IgG from Baseline 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)]
- Change from Baseline in Myasthenia Gravis-Activities of Daily Living (MG ADL) total score at 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)]
- Change from Baseline in Quantitative Myasthenia Gravis (QMG) total score at 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)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 3 centers
- Mg0008 40290 — Bologna
- Mg0008 40144 — Milan
- Mg0008 40733 — Naples
Japan · 3 centers
- Mg0008 20340 — Fuchu-shi
- Mg0008 20339 — Ōbu
- Mg0008 20343 — Sagamihara
Poland · 2 centers
- Mg0008 40155 — Warsaw
- Mg0008 40734 — Warsaw
Taiwan · 2 centers
- Mg0008 20081 — Taipei
- Mg0008 20095 — Taipei
Identifiers
NCT: NCT06540144 · MG0008 · 2022-502075-34 · U1111-1286-3581