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Recruiting Phase 2/3 NCT06149559

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

Phase 2/3 – combined trial
Conditions: Generalized Myasthenia Gravis

Sponsor: UCB Biopharma SRL

trial.available_in: БГ
Overview
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).
Who can participate
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
Interventions
rozanolixizumab
DRUG
Locations 13
Italy (3)
Mg0006 40290
Bologna
Mg0006 40144
Milan
Mg0006 40733
Naples
Japan (3)
Mg0006 20340
Fuchu-shi
Mg0006 20339
Ōbu
Mg0006 20343
Sagamihara
Poland (2)
Mg0006 40155
Warsaw
Mg0006 40734
Warsaw
Taiwan (2)
Mg0006 20081
Taipei
Mg0006 20095
Taipei
Turkey (2)
Mg0006 40841
Altindağ/ankara
Mg0006 40836
Kocaeli
United States (1)
Mg0006 50574
Flower Mound , Texas
WITHDRAWN
Technical details
Status
Recruiting
Phase
Phase 2/3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
2 Years
Maximum age
17 Years
Healthy volunteers
No
Start date
14.06.2024
Completion date
17.08.2026
Registry ID
NCT06149559
Source
clinicaltrials.gov
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