Clinical trial NCT05737160: Study of Telitacicept in Generalized Myasthenia Gravis
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Study of Telitacicept in Patients With Generalized Myasthenia Gravis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myasthenia Gravis, Generalized
Keywords: Myasthenia Gravis
Autoimmune Diseases
Muscle Weakness
Lead sponsor: RemeGen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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);

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

Primary outcomes:
measure: Change from baseline in MG-ADL
timeFrame: Week 24
Secondary outcomes:
measure: Change from baseline in MG-ADL
timeFrame: Weeks12, 36, 48
measure: Change from baseline in QMG
timeFrame: Weeks 12, 24, 36, 48
measure: Proportion of subjects with ≥ 3 points reduction from baseline in MG-ADL
timeFrame: Weeks 24, 48
measure: Proportion of subjects with a decrease of ≥ 5 points from baseline in QMG
timeFrame: Weeks 24, 48
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital of Capital Medical University
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Nanyang
country: China
facility: Nanyang First People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: Third Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Huhhot
country: China
facility: Inner Mongolia Autonomous Region People's Hospital
state: Inner Mongolia
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: Dalian Municipal Central Hospital
state: Liaoning
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Dalian
country: China
facility: The Second Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Jinzhou
country: China
facility: The First Affiliated Hospital of Jinzhou Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital Affiliated to China Medical University
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: The People's Hospital of Liaoning Province
state: Liaoning
city: Xi'an
country: China
facility: The Second Affiliated Hospital of PLA Air Force Military Medical University
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an Hi-tech Hospital
state: Shaanxi
city: Xianyang
country: China
facility: Xianyang Hospital of Yan'an University
state: Shaanxi
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jining
country: China
facility: Jining No.1 People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Taiyuan
country: China
facility: The First Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Nanchong
country: China
facility: Affiliated Hospital of North Sichuan Medical College
state: Sichuan
city: Urumqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
state: Yunnan
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, affiliated with to Zhejiang University College of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: