Status:
ENROLLING_BY_INVITATION
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
Lead Sponsor:
UCB Biopharma SRL
Conditions:
Generalized Myasthenia Gravis
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 17 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06540144
Start Date
October 8 2024
End Date
August 17 2027
Last Update
December 15 2025
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Mg0008 40290
Bologna, Italy
2
Mg0008 40144
Milan, Italy
3
Mg0008 40733
Napoli, Italy
4
Mg0008 20340
Fuchu-shi, Japan