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Trial Title:
A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (RemeMG)
NCT ID:
NCT06456580
Condition:
Generalized Myasthenia Gravis
Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Conditions: Keywords:
Myasthenia Gravis
gMG
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Biological
Intervention name:
Telitacicept
Description:
Subcutaneous injection
Arm group label:
Telitacicept
Other name:
RC18
Other name:
RC18-L
Intervention type:
Drug
Intervention name:
Placebo
Description:
Subcutaneous injection
Arm group label:
Placebo
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.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. Male or female patient aged ≥18 years at screening.
2. Patients have prior confirmed diagnosis of gMG with generalized muscle weakness
(typical pattern of weakness meeting the clinical criteria for diagnosis of MG as
defined by the Myasthenia Gravis Foundation of America (MGFA) clinical
classification II-IV.
3. Patients have positive antibodies against AChR or MuSK at screening.
4. MG-ADL score ≥6 points at screening and baseline with ocular-related score <50% of
the total score.
5. QMG score ≥11 points at screening and baseline.
Key Exclusion Criteria:
1. Patients have been diagnosed with any other autoimmune disease.
2. Patients having acute or chronic infection.
3. Patients having thymoma within 5 years or received thymectomy ≤6 months prior to
screening.
4. Patients having current or history of primary immunodeficiency.
5. Patients having history of malignancy within the last 5 years.
6. Patient having prior or continuing diagnosis of serious cardiovascular disease.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Boca Raton, Florida Site
Address:
City:
Boca Raton
Zip:
33487
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Miami, Florida Site
Address:
City:
Miami
Zip:
33155
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Port Charlotte, Florida Site
Address:
City:
Port Charlotte
Zip:
33952
Country:
United States
Status:
Recruiting
Start date:
July 17, 2024
Completion date:
October 2027
Lead sponsor:
Agency:
RemeGen Co., Ltd.
Agency class:
Industry
Source:
RemeGen Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06456580
