NCT06055959

A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis

A Multicenter Open-Label, Uncontrolled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Activity of Zilucoplan in Pediatric Study Participants From 2 to Less Than 18 Years of Age With Acetylcholine Receptor Antibody Positive Generalized Myasthenia Gravis

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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 myasthenia gravis (gMG).

Conditions

• Generalized Myasthenia Gravis

Interventions

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

Timeline

• Start date: 2024-10-16
• Primary completion: 2026-11-16
• Completion: 2026-12-25
• First posted: 2023-09-28
• Last updated: 2026-04-13

Locations

9 sites across 5 countries: United States, Italy, Poland, South Korea, United Kingdom

Regulatory

• FDA-regulated drug study