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
NCT05514873 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2025-09-03
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
Interventions
- DRUG
-
zilucoplan (RA101495)
Subcutaneous injection
Sponsors & Collaborators
-
UCB Biopharma SRL
lead INDUSTRY
Principal Investigators
-
UCB Cares · 001 844 599 2273
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-31
- Primary Completion
- 2024-03-13
- Completion
- 2024-10-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis
NCT06149559 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis
NCT04225871 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Effectiveness and Safety of Zilucoplan Treatment for French Patients With Myasthenia Gravis Over 3 Months
NCT06815133 ·Status: RECRUITING
-
Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia Gravis
NCT05132569 ·Status: TERMINATED ·Phase: PHASE3
-
A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
NCT04124965 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)
NCT05681715 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy
NCT04025632 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
NCT04951622 ·Status: RECRUITING ·Phase: PHASE3
-
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
NCT06540144 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE3
-
A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
NCT02965573 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
NCT04650854 ·Status: COMPLETED ·Phase: PHASE3
-
Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis
NCT01828294 ·Status: TERMINATED ·Phase: PHASE1
-
Safety,Tolerability,Pharmacokinetics and Efficacy of CFZ533 in Moderate to Severe Myasthenia Gravis
NCT02565576 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG)
NCT07215650 ·Status: RECRUITING ·Phase: PHASE1
-
Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
NCT03920293 ·Status: COMPLETED ·Phase: PHASE3
-
A Pilot Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Generalized Myasthenia Gravis
NCT01555580 ·Status: UNKNOWN ·Phase: EARLY_PHASE1
-
A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
NCT03971422 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of CNP-106 in Subjects With Myasthenia Gravis
NCT06106672 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
The Evaluation of Belimumab in Myasthenia Gravis (MG)
NCT01480596 ·Status: COMPLETED ·Phase: PHASE2
-
Rituximab EfFicacy IN MyasthEnia Gravis (REFINE)
NCT05868837 ·Status: RECRUITING ·Phase: PHASE3
-
Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis
NCT03052751 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia Gravis
NCT02473952 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis
NCT05403541 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
NCT06455449 ·Status: RECRUITING ·Phase: PHASE3
-
Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis
NCT00727194 ·Status: TERMINATED ·Phase: PHASE2