Study of Telitacicept in Generalized Myasthenia Gravis

Phase 3

Completed

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

• Registration Number: NCT05737160
• 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 patients with generalized myasthenia gravis.

Detailed Description

This study consists of a screening period, a double-blind treatment period (part A) and an open-label treatment period (part B). After screening, eligible subjects will be randomized in a 1: 1 ratio to receive either subcutaneous Telitacicept 240 mg or placebo once a week for 24 doses (part A). Completing part A, subjects will automatically enter part B. In part B, all subjects will receive weekly subcutaneous Telitacicept 240 mg for 24 weeks.

Study Timeline

• Study First Submitted: 2023-02-12
• Study First Submitted QC: 2023-02-12
• Study First Posted: 2023-02-21
• Study Start: 2023-03-28
• Status Verified: 2024-10
• Primary Completion: 2024-11-26
• Study Completion: 2024-12-12
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

1. Written informed consent provided;
2. Male or female patients aged 18-80 years;
3. Diagnosis with generalized myasthenia gravis;
4. MGFA Class II, III, or IVa;
5. AChR-Ab or MuSK-Ab positive;
6. A total MG-ADL score of ≥ 6 with less than 50% of the total score due to ocular symptoms;
7. QMG ≥ 8, with ≥ 4 items score at least 2;
8. Have been on a stable MG SoC regimen.

Exclusion Criteria

1. Patients with autoimmune diseases other than MG;
2. Abnormal laboratory results；
3. Use of immunosuppressants other than standard therapy within 1 month before randomization;
4. Use of biologic agents targeting therapy, such as Rituximab or complement C5 inhibitors, within 6 months before randomization;
5. Use of neonatal Fc receptor (FcRn) antagonists, intravenous immunoglobulin (IVIg), or plasmapheresis within 2 months before randomization;
6. Significant cardiovascular disease, liver, kidney, respiratory, endocrine or hematologic disease, or other medical conditions that, in the opinion of the investigator, would preclude the subject's participation in the study or require hospitalization during the study;
7. Acute or chronic infection requiring treatment;
8. Current active hepatitis;
9. HIV antibody positive;
10. Patients currently suffering from thymoma-associated immunodeficiency syndrome (Good's syndrome) or who underwent thymectomy within 6 months before screening;
11. Received or plan to receive any live vaccine within 3 months prior to randomization;
12. Patients with malignant tumors;
13. Allergy to biological products of human origin;
14. Participation in any clinical trial 28 days prior to randomization or within 5 times the half-life of an investigational drug (whichever is longer);
15. Pregnant or lactating women, and those intending to become pregnant during the trial;
16. Patients considered unsuitable by the investigator to participate in the trial (e.g., patients with severe mental disorders);

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive subcutaneous placebo once a week for a total of 24 doses (part A) and then weekly subcutaneous Telitacicept 240 mg for 24 doses (part B) in addition to MG SoC.
Telitacicept	Telitacicept	Participants will receive subcutaneous Telitacicept 240 mg once a week for a total of 48 doses in addition to MG SoC.

Primary Outcome Measures

Name	Time	Method
Change from baseline in MG-ADL	Week 24	The MG-ADL is an 8-item patient-reported scale that measures MG symptoms and functional status. Each item ranges from 0 to 3 for a total score range of 0 to 24.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in QMG	Weeks 12, 24, 36, 48	The quantitative myasthenia gravis (QMG) score is a 13-item scale used to quantify disease severity in myasthenia gravis (MG). Total QMG score ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits).
Change from baseline in MG-ADL	Weeks12, 36, 48	The MG-ADL is an 8-item patient-reported scale that measures MG symptoms and functional status. Each item ranges from 0 to 3 for a total score range of 0 to 24.
Proportion of subjects with ≥ 3 points reduction from baseline in MG-ADL	Weeks 24, 48	The MG-ADL is an 8-item patient-reported scale that measures MG symptoms and functional status. Each item ranges from 0 to 3 for a total score range of 0 to 24.
Proportion of subjects with a decrease of ≥ 5 points from baseline in QMG	Weeks 24, 48	The quantitative myasthenia gravis (QMG) score is a 13-item scale used to quantify disease severity in myasthenia gravis (MG). Total QMG score ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits).

Trial Locations

Locations (51)

The First Affiliated Hospital of Bengbu Medical College; 🇨🇳 Bengbu, Anhui, China

Anhui Provincial Hospital; 🇨🇳 Hefei, Anhui, China

Beijing Hospital; 🇨🇳 Beijing, Beijing, China

Xuanwu Hospital of Capital Medical University; 🇨🇳 Beijing, Beijing, China

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China

Lanzhou University Second Hospital; 🇨🇳 Lanzhou, Gansu, China

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Affiliated Hospital of Zunyi Medical University; 🇨🇳 Zunyi, Guizhou, China

The Second Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

The Second Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

Scroll for more (41 remaining)