Study of Telitacicept in Generalized Myasthenia Gravis

Myasthenia Gravis, Generalized Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Study of Telitacicept in Patients With Generalized Myasthenia Gravis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05737160
• Other study ID #: 18C029
• Status: Recruiting
• Phase: Phase 3
• Start date: March 28, 2023
• Est. completion date: May 2027

Study information

• Verified date: October 2023
• Source: RemeGen Co., Ltd.
• Contact: Binghua Xiao
• Phone: 86-101-58076833
• Email: binghua.xiao[@]remegen.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 patients with generalized myasthenia gravis.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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. 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;

4. Acute or chronic infection requiring treatment;

5. Current active hepatitis;

6. HIV antibody positive;

7. Current thymoma-associated immunodeficiency syndrome (Good's syndrome) or thymic surgery within 6 months prior to screening;

8. Received or plan to receive any live vaccine within 3 months prior to randomization;

9. Patients with malignant tumors;

10. Allergy to biological products of human origin;

11. Participation in any clinical trial 28 days prior to randomization or within 5 times the half-life of an investigational drug (whichever is longer);

12. Pregnant or lactating women, and those intending to become pregnant during the trial;

13. 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.

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis
• Myasthenia Gravis, Generalized

Intervention

Biological:
• Telitacicept
Administered as an SC infusion

Drug:
• Placebo
Administered as an SC infusion

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing
China	Xuanwu Hospital of Capital Medical University	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	China-Japan Union Hospital of Jilin University	Changchun	Jilin
China	The First Hospital of Jilin University	Changchun	Jilin
China	Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
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	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
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 Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	Inner Mongolia Autonomous Region People's Hospital	Huhhot	Inner Mongolia
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Jining No.1 People's Hospital	Jining	Shandong
China	The First Affiliated Hospital of Jinzhou Medical University	Jinzhou	Liaoning
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	Lanzhou University Second Hospital	Lanzhou	Gansu
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	Affiliated Hospital of North Sichuan Medical College	Nanchong	Sichuan
China	Nanjing First Hospital	Nanjing	Jiangsu
China	Nanyang First People's Hospital	Nanyang	Henan
China	Huashan Hospital Affiliated to Fudan University	Shanghai	Shanghai
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 Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
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	First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
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	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	Henan Provincial People's Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
RemeGen Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in MG-ADL	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.	Week 24
Secondary	Change from baseline in MG-ADL	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.	Weeks12, 36, 48
Secondary	Change from baseline in QMG	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).	Weeks 12, 24, 36, 48
Secondary	Proportion of subjects with = 3 points reduction from baseline in MG-ADL	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.	Weeks 24, 48
Secondary	Proportion of subjects with a decrease of = 5 points from baseline in QMG	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).	Weeks 24, 48