Generalized Myasthenia Gravis Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study With an Open-label Extension Period to Evaluate the Efficacy and Safety of Telitacicept in Patients With Generalized Myasthenia Gravis
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.
Myasthenia gravis (MG) is an autoimmune disease that affects the neuromuscular junction on the postsynaptic membrane. The predominant manifestation is muscle weakness, which typically worsens with repeated muscle exertion, such that function is usually the best in the morning with more pronounced weakness at the end of the day. A major challenge in MG is the lack of therapies that cure the disease. Telitacicept is a fully human TACI-Fc fusion protein that targets B-lymphocyte stimulator (BLyS) and A proliferating-inducing ligand (APRIL), neutralizing their interactions with receptors on B cells. The blockage of BLyS and APRIL interaction with their respective cell membrane receptors (transmembrane activator and CAML interactor [TACI], B-cell maturation antigen, and BLyS receptors) by telitacicept would inhibit B-cell proliferation and maturation. This suppression at the proximal portion of the immune response could alleviate autoimmune symptoms. This study is a randomized, double-blind, placebo-controlled Phase 3 study with an open-label extension to evaluate the efficacy and safety of telitacicept in a global patient population with gMG. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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
|
Phase 3 | |
Completed |
NCT04124965 -
A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
|
Phase 3 | |
Recruiting |
NCT04833894 -
Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT04963270 -
A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis
|
Phase 3 | |
Active, not recruiting |
NCT02950155 -
A Study Evaluating the Safety and Efficacy of Rituximab in Patients With Myasthenia Gravis
|
Phase 3 | |
Completed |
NCT03315130 -
Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis
|
Phase 2 | |
Recruiting |
NCT05556096 -
Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis
|
Phase 3 | |
Not yet recruiting |
NCT06392386 -
A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis
|
Phase 3 | |
Not yet recruiting |
NCT06149559 -
A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT06193889 -
A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Subjects With Refractory Generalized Myasthenia Gravis
|
Phase 2 | |
Completed |
NCT03920293 -
Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
|
Phase 3 | |
Completed |
NCT03770403 -
A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.
|
Phase 3 | |
Not yet recruiting |
NCT06447597 -
A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.
|
Phase 2/Phase 3 | |
Completed |
NCT03971422 -
A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
|
Phase 3 | |
Recruiting |
NCT05403541 -
Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis
|
Phase 3 | |
Recruiting |
NCT05644561 -
Evaluation of Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, and Immunogenicity of Ravulizumab Administered Intravenously in Pediatric Participants With Generalized Myasthenia Gravis (gMG)
|
Phase 3 | |
Not yet recruiting |
NCT06463587 -
Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)
|
Phase 3 | |
Recruiting |
NCT06055959 -
A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
|
Phase 2/Phase 3 | |
Completed |
NCT00515450 -
Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
|
Phase 3 | |
Recruiting |
NCT06064695 -
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Myasthenia Gravis
|
N/A |