A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (RemeMG)

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06456580
• Other study ID #: RC18G006
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: July 2027

Study information

• Verified date: June 2024
• Source: RemeGen Co., Ltd.
• Contact: RemeGen
• Phone: 800-910-6542
• Email: RC18_MGstudy[@]remegenbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: July 2027
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Generalized Myasthenia Gravis
• Muscle Weakness
• Myasthenia Gravis

Intervention

Biological:
• Telitacicept
Subcutaneous injection

Drug:
• Placebo
Subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RemeGen Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in MG-ADL score at Week 24	Change from baseline in MG-ADL score at Week 24	Week 24
Secondary	Change from baseline in QMG score at Week 24	Change from baseline in QMG score at Week 24	Week 24
Secondary	Change from baseline in MG Quality of Life scale (MG-QOL15r) at Week 24	Change from baseline in MG Quality of Life scale (MG-QOL15r) at Week 24	Week 24
Secondary	Proportion of patients with a decrease of =2 points from baseline in MG-ADL score at Week 24	Proportion of patients with a decrease of =2 points from baseline in MG-ADL score at Week 24	Week 24
Secondary	Proportion of patients with a decrease of =3 points from baseline in QMG score at Week 24	Proportion of patients with a decrease of =3 points from baseline in QMG score at Week 24	Week 24
Secondary	Proportion of patients who achieved minimal symptomatic expression (MSE, defined as having MG-ADL score of 0 or 1) at Week 24	Proportion of patients who achieved minimal symptomatic expression (MSE, defined as having MG-ADL score of 0 or 1) at Week 24	Week 24