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Trial Title:
An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
NCT ID:
NCT06435312
Condition:
Generalized Myasthenia Gravis
Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Conditions: Keywords:
generalized Myasthenia Gravis
gMG
RA101495
Zilucoplan
pediatric
MG0015
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Zilucoplan
Description:
Zilucoplan will be administered subcutaneously to pediatric study participants
Arm group label:
Zilucoplan Arm
Other name:
RA101495
Summary:
The purpose of this study is to assess the long-term safety and tolerability of an
additional 52 weeks of Zilucoplan treatment administered by subcutaneous injection once
daily in pediatric study participants
Criteria for eligibility:
Criteria:
Inclusion Criteria:
United States of America (USA) specific inclusion criterion:
- Participant must be ≥ 12 years of age at the time of signing the Informed
Consent/Assent according to local regulation.
Rest of World (ROW) specific inclusion criterion:
- Participant must be ≥ 2 years of age at the time of signing the Informed
Consent/Assent according to local regulation.
Global specific inclusion criteria:
- Participant has completed the MG0014 according to the protocol, and further
treatment with zilucoplan is in the interest of the participant in the
investigator´s opinion
- Participant agrees to receive booster vaccinations against meningococcal infections
during the study, if clinically indicated according to the local standard of care
Exclusion Criteria:
- Study participant met any mandatory investigational medicinal product (IMP)
withdrawal or mandatory permanent discontinuation criteria in MG0014 or permanently
discontinued IMP
- Participant has known positive serology for muscle-specific kinase
- Participant has known hypersensitivity to any components of the IMP
- Participant has a prior history of meningococcal disease
Gender:
All
Minimum age:
12 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 28, 2024
Completion date:
December 7, 2027
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/NCT06435312
