Status:
RECRUITING
A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
Lead Sponsor:
UCB Biopharma SRL
Conditions:
Generalized Myasthenia Gravis
Eligibility:
All Genders
12-17 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, safety, tolerability, immunogenicity and activity of zilucoplan (ZLP) in pediatric study participants with generalized my...
Eligibility Criteria
Inclusion
- United States of America (USA) specific inclusion criterion:
- \- Participant must be 12 to \<18 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 to \<18 years of age at the time of signing the Informed consent/assent according to local regulation
- Global inclusion criteria:
- Participant has a diagnosis of generalized myasthenia gravis (gMG) confirmed by a prior positive serologic test result to acetylcholine receptor (AChR) prior to Screening
- Participant meets the criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification II to IV at Screening
- Participants with gMG, including:
- An MG-activities of daily living (MG-ADL) total score of 6 or more in adolescents from 12 years to \<18 years of age at Screening
- Documented weakness in at least 1 limb, neck, or bulbar muscle in children from 2 years to \<12 years of age at Screening (does not apply to US)
- Documented vaccination against meningococcal infections within 3 years prior to study start. If not fully vaccinated, participants must receive appropriate prophylactic antibiotic treatment until at least 2 weeks after the initial dose of vaccine(s)
Exclusion
- Participant has known positive serology for muscle-specific kinase
- Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study
- Participant has had a thymectomy within 6 months prior to Baseline
- Participant has minimal Manifestation Status of MG based on the clinical judgement of the Investigator
- Current or recent systemic infection within 2 weeks prior to Baseline or infection requiring intravenous antibiotics within 4 weeks prior to Baseline
Key Trial Info
Start Date :
October 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 25 2026
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06055959
Start Date
October 16 2024
End Date
December 25 2026
Last Update
January 6 2026
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Mg0014 50168
Chicago, Illinois, United States, 60611
2
Mg0014 50574
Denton, Texas, United States, 76208
3
Mg0014 40144
Milan, Italy
4
Mg0014 40774
Katowice, Poland