Study of Telitacicept in Generalized Myasthenia Gravis

NCT ID: NCT05737160

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-28
• Study Completion Date: 2024-12-12

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.

Conditions

Myasthenia Gravis, Generalized

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Telitacicept

Participants will receive subcutaneous Telitacicept 240 mg once a week for a total of 48 doses in addition to MG SoC.

Group Type: EXPERIMENTAL

Telitacicept

Intervention Type: BIOLOGICAL

Administered as an SC infusion

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered as an SC infusion

Interventions

Telitacicept

Administered as an SC infusion

Intervention Type: BIOLOGICAL

Placebo

Administered as an SC infusion

Intervention Type: DRUG

Other Intervention Names

RC18

Eligibility Criteria

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);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RemeGen Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Anhui Provincial Hospital

Hefei, Anhui, China

Beijing Hospital

Beijing, Beijing Municipality, China

Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 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

Nanyang First People's Hospital

Nanyang, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

Inner Mongolia Autonomous Region People's Hospital

Hohhot, Inner Mongolia, China

Nanjing First Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

China-Japan Union Hospital of Jilin University

Changchun, Jilin, China

The First Hospital of Jilin University

Changchun, Jilin, China

Dalian Municipal Central Hospital

Dalian, Liaoning, China

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, China

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

The People's Hospital of Liaoning Province

Shenyang, Liaoning, China

The Second Affiliated Hospital of PLA Air Force Military Medical University

Xi'an, Shaanxi, China

Xi'an Hi-tech Hospital

Xi'an, Shaanxi, China

Xianyang Hospital of Yan'an University

Xianyang, Shaanxi, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Jining No.1 People's Hospital

Jining, Shandong, China

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, China

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Sir Run Run Shaw Hospital, affiliated with to Zhejiang University College of Medicine

Hangzhou, Zhejiang, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Countries

China

Other Identifiers

18C029

Identifier Type: -

Identifier Source: org_study_id