Status:
RECRUITING
A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis
Lead Sponsor:
UCB Biopharma SRL
Conditions:
Generalized Myasthenia Gravis
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
PHASE3
Brief Summary
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 Gra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 17 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06149559
Start Date
June 14 2024
End Date
August 17 2026
Last Update
January 6 2026
Active Locations (12)
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1
Mg0006 50574
Denton, Texas, United States, 76208
2
Mg0006 40290
Bologna, Italy
3
Mg0006 40144
Milan, Italy
4
Mg0006 40733
Napoli, Italy