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Trial Title:
A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis
NCT ID:
NCT06149559
Condition:
Generalized Myasthenia Gravis
Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Rozanolixizumab
Conditions: Keywords:
Generalized Myasthenia Gravis
gMG
rozanolixizumab
pediatric
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
rozanolixizumab
Description:
rozanolixizumab solution for injection
Arm group label:
rozanolixizumab
Other name:
UCB7665
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 Gravis (gMG).
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
2 Years
Maximum age:
17 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Mg0006 50574
Address:
City:
Denton
Zip:
76208
Country:
United States
Status:
Withdrawn
Facility:
Name:
Mg0006 40290
Address:
City:
Bologna
Country:
Italy
Status:
Recruiting
Facility:
Name:
Mg0006 40144
Address:
City:
Milano
Country:
Italy
Status:
Recruiting
Facility:
Name:
Mg0006 40734
Address:
City:
Lodz
Country:
Poland
Status:
Recruiting
Facility:
Name:
Mg0006 20081
Address:
City:
Taipei City
Country:
Taiwan
Status:
Recruiting
Start date:
June 14, 2024
Completion date:
August 17, 2026
Lead sponsor:
Agency:
UCB Biopharma SRL
Agency class:
Industry
Source:
UCB Pharma
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06149559
