Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456580
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-07
Brief Title:
A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis RemeMG
Sponsor:
RemeGen Co Ltd
Organization:
RemeGen Co Ltd
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None