NCT06435312

An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis

An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Zilucoplan in Pediatric Study Participants With Acetylcholine Receptor Antibody Positive Generalized Myasthenia Gravis

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

Conditions

• Generalized Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	Zilucoplan	Zilucoplan will be administered subcutaneously to pediatric study participants

Timeline

• Start date: 2024-11-19
• Primary completion: 2027-10-26
• Completion: 2027-11-19
• First posted: 2024-05-30
• Last updated: 2026-04-13

Locations

7 sites across 4 countries: Italy, Poland, South Korea, United Kingdom

Regulatory

• FDA-regulated drug study