Clinical trial
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
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
ClinicalTrials.gov ID: NCT05514873
Sponsor: UCB Biopharma SRL
Information provided by: UCB Biopharma SRL (Responsible Party)
Last Update Posted: 2023-07-24
Brief 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)
OFFICIAL TITLE
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
INTERVENTION / TREATMENT
Drug: zilucoplan (RA101495)
| Category | Value |
|---|---|
| Study Start (Estimated) | 2022-10-31 |
| Primary Completion (Estimated) | 2024-03-11 |
| Study Completion | 2024-03-11 |
| Enrollment (Estimated) | 20 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers | MG0017 |