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

Phase 3

Recruiting

• Conditions: Generalized Myasthenia Gravis
• Interventions: Biological: Telitacicept; Drug: Placebo

• Registration Number: NCT06456580
• Lead Sponsor: RemeGen Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2024-06-07
• Study First Submitted QC: 2024-06-07
• Study First Posted: 2024-06-13
• Study Start: 2024-07-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2026-07
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telitacicept	Telitacicept	Telitacicept
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score at Week 24	Week 24	The MG-ADL is an 8-item patient-reported outcome measure assessing MG symptoms and their effects on daily activities. Each item in the scale scored 0 to 3 (0=normal, 3=severe disease) point scale. The total score was the sum of all individual item scores and ranged from 0 to 24. Higher scores indicated more severe disability due to MG. A decrease from Baseline score indicated improvement.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with a decrease of ≥2 points from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score at Week 24	Week 24	Proportion of patients with a decrease of ≥2 points from baseline in MG-ADL score at Week 24. The MG-ADL is an 8-item patient-reported outcome measure assessing MG symptoms and their effects on daily activities. Each item in the scale scored on a 0 to 3 (0=normal, 3=severe disease) point scale. The total score was the sum of all individual item scores and ranged from 0 to 24. Higher scores indicated more severe disability due to MG.
Proportion of patients with a decrease of ≥3 points from baseline in Quantitative Myasthenia Gravis (QMG) score at Week 24	Week 24	Proportion of patients with a decrease of ≥3 points from baseline in QMG score at Week 24. The QMG is a standardized and validated quantitative strength scoring system that was developed specifically for MG. The scale consisted of 13 items. Each item in the scale scored on a 0 to 3-point scale, ranging from 0 (no weakness) to 3 (severe weakness), summing up to the overall score range from 0 to 39. Higher scores indicated more severe impairment. A decrease from Baseline score indicated improvement.
Proportion of patients who achieved minimal symptomatic expression (MSE, defined as having MG-ADL score of 0 or 1) at Week 24	Week 24	Proportion of patients who achieved minimal symptomatic expression (MSE, defined as having MG-ADL score of 0 or 1) at Week 24
Change from baseline in MG Quality of Life scale (MG-QOL15r) at Week 24	Week 24	The MG-QoL15r is a 15-item patient-reported outcome measure designed to assess quality of life in patients with MG. Each item in the scale scored on a 0 to 2-point scale (0=Not at all, 1=Somewhat, 2=Very much). The total score was the sum of the 15 individual item scores, ranging from 0 to 30. Higher scores indicated more severe impact of the disease on aspects of the patient's life. A decrease from Baseline score indicated improvement.
Change from baseline in Quantitative Myasthenia Gravis (QMG) score at Week 24	Week 24	The QMG is a standardized and validated quantitative strength scoring system that was developed specifically for MG. The scale consisted of 13 items. Each item in the scale scored on a 0 to 3-point scale, ranging from 0 (no weakness) to 3 (severe weakness), summing up to the overall score range from 0 to 39. Higher scores indicated more severe impairment. A decrease from Baseline score indicated improvement.

Trial Locations

Locations (13)

Orange Site; 🇺🇸 Orange, California, United States

Lexington Site; 🇺🇸 Lexington, Kentucky, United States

Foxboro Site; 🇺🇸 Foxboro, Massachusetts, United States

Greenfield Site; 🇺🇸 Greenfield, Wisconsin, United States

Bydgoszcz Site; 🇵🇱 Bydgoszcz, Kujawsko-Pomorskie, Poland

Lublin Site; 🇵🇱 Lublin, Lubelskie, Poland

Lublin; 🇵🇱 Lublin, Lubuskie, Poland

Kraków Site; 🇵🇱 Kraków, Malopolskie, Poland

Katowice Site; 🇵🇱 Katowice, Slaskie, Poland

Poznań Site; 🇵🇱 Poznań, Wielkopolskie, Poland

Boca Raton, Florida Site; 🇺🇸 Boca Raton, Florida, United States

Miami, Florida Site; 🇺🇸 Miami, Florida, United States

Port Charlotte, Florida Site; 🇺🇸 Port Charlotte, Florida, United States