NCT05514873

An Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Zilucoplan in Participants With Generalized Myasthenia Gravis Who Were Previously Receiving Intravenous Complement Component 5 Inhibitors

A Phase 3b, Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety, Tolerability, and Efficacy of Zilucoplan in Participants With Generalized Myasthenia Gravis Switching From Intravenous Complement Component 5 Inhibitors to Subcutaneous Zilucoplan

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety and tolerability of switching from intravenous (IV) complement component 5 (C5) inhibitors to subcutaneous (SC) Zilucoplan in study participants with generalized myasthenia gravis (gMG)

Conditions

• Generalized Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	zilucoplan (RA101495)	Subcutaneous injection

Timeline

• Start date: 2022-10-31
• Primary completion: 2024-03-13
• Completion: 2024-10-23
• First posted: 2022-08-25
• Last updated: 2025-09-03
• Results posted: 2025-03-30

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study