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Study of Telitacicept in Generalized Myasthenia Gravis

Primary Purpose

Myasthenia Gravis, Generalized

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Telitacicept
Placebo
Sponsored by
RemeGen Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myasthenia Gravis, Generalized focused on measuring Myasthenia Gravis, Autoimmune Diseases, Muscle Weakness

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written informed consent provided; Male or female patients aged 18-80 years; Diagnosis with generalized myasthenia gravis; MGFA Class II, III, or IVa; AChR-Ab or MuSK-Ab positive; A total MG-ADL score of ≥ 6 with less than 50% of the total score due to ocular symptoms; QMG ≥ 8, with ≥ 4 items score at least 2; Have been on a stable MG SoC regimen. Exclusion Criteria: Patients with autoimmune diseases other than MG; Abnormal laboratory results； 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; Acute or chronic infection requiring treatment; Current active hepatitis; HIV antibody positive; Current thymoma-associated immunodeficiency syndrome (Good's syndrome) or thymic surgery within 6 months prior to screening; Received or plan to receive any live vaccine within 3 months prior to randomization; Patients with malignant tumors; Allergy to biological products of human origin; Participation in any clinical trial 28 days prior to randomization or within 5 times the half-life of an investigational drug (whichever is longer); Pregnant or lactating women, and those intending to become pregnant during the trial; 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.

Sites / Locations

  • The First Affiliated Hospital of Bengbu Medical CollegeRecruiting
  • Anhui Provincial HospitalRecruiting
  • Beijing HospitalRecruiting
  • Xuanwu Hospital of Capital Medical UniversityRecruiting
  • Fujian Medical University Union HospitalRecruiting
  • Lanzhou University Second HospitalRecruiting
  • The First Affiliated Hospital of Sun Yat-sen UniversityRecruiting
  • Affiliated Hospital of Zunyi Medical UniversityRecruiting
  • The Second Hospital of Hebei Medical UniversityRecruiting
  • The Second Affiliated Hospital of Harbin Medical UniversityRecruiting
  • Nanyang First People's HospitalRecruiting
  • Henan Provincial People's HospitalRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • Renmin Hospital of Wuhan UniversityRecruiting
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
  • Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
  • Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)Recruiting
  • Zhongnan Hospital of Wuhan UniversityRecruiting
  • Third Xiangya Hospital of Central South UniversityRecruiting
  • Xiangya Hospital of Central South UniversityRecruiting
  • Inner Mongolia Autonomous Region People's HospitalRecruiting
  • Nanjing First HospitalRecruiting
  • The First Affiliated Hospital of Soochow UniversityRecruiting
  • Jiangxi Provincial People's HospitalRecruiting
  • China-Japan Union Hospital of Jilin UniversityRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • Dalian Municipal Central HospitalRecruiting
  • The First Affiliated Hospital of Dalian Medical UniversityRecruiting
  • The Second Affiliated Hospital of Dalian Medical UniversityRecruiting
  • The First Affiliated Hospital of Jinzhou Medical UniversityRecruiting
  • Shengjing Hospital Affiliated to China Medical UniversityRecruiting
  • The First Hospital of China Medical UniversityRecruiting
  • The People's Hospital of Liaoning ProvinceRecruiting
  • The Second Affiliated Hospital of PLA Air Force Military Medical UniversityRecruiting
  • Xi'an Hi-tech HospitalRecruiting
  • Xianyang Hospital of Yan'an UniversityRecruiting
  • Qilu Hospital of Shandong UniversityRecruiting
  • Jining No.1 People's HospitalRecruiting
  • Huashan Hospital Affiliated to Fudan UniversityRecruiting
  • Shanxi Bethune HospitalRecruiting
  • Shanxi Provincial People's HospitalRecruiting
  • The First Hospital of Shanxi Medical UniversityRecruiting
  • West China Hospital, Sichuan UniversityRecruiting
  • Affiliated Hospital of North Sichuan Medical CollegeRecruiting
  • First Affiliated Hospital of Xinjiang Medical UniversityRecruiting
  • The First Affiliated Hospital of Kunming Medical UniversityRecruiting
  • The First People's Hospital of Yunnan ProvinceRecruiting
  • The Second Affiliated Hospital of Kunming Medical UniversityRecruiting
  • Sir Run Run Shaw Hospital, affiliated with to Zhejiang University College of MedicineRecruiting
  • Zhejiang Provincial People's HospitalRecruiting
  • The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Telitacicept

Placebo

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.
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).

Full Information

First Posted
February 12, 2023
Last Updated
October 10, 2023
Sponsor
RemeGen Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05737160
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RemeGen Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myasthenia Gravis, Generalized
Keywords
Myasthenia Gravis, Autoimmune Diseases, Muscle Weakness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telitacicept
Arm Type
Experimental
Arm Description
Participants will receive subcutaneous Telitacicept 240 mg once a week for a total of 48 doses in addition to MG SoC.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Telitacicept
Other Intervention Name(s)
RC18
Intervention Description
Administered as an SC infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered as an SC infusion
Primary Outcome Measure Information:
Title
Change from baseline in MG-ADL
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Change from baseline in MG-ADL
Description
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.
Time Frame
Weeks12, 36, 48
Title
Change from baseline in QMG
Description
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).
Time Frame
Weeks 12, 24, 36, 48
Title
Proportion of subjects with ≥ 3 points reduction from baseline in MG-ADL
Description
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.
Time Frame
Weeks 24, 48
Title
Proportion of subjects with a decrease of ≥ 5 points from baseline in QMG
Description
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).
Time Frame
Weeks 24, 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent provided; Male or female patients aged 18-80 years; Diagnosis with generalized myasthenia gravis; MGFA Class II, III, or IVa; AChR-Ab or MuSK-Ab positive; A total MG-ADL score of ≥ 6 with less than 50% of the total score due to ocular symptoms; QMG ≥ 8, with ≥ 4 items score at least 2; Have been on a stable MG SoC regimen. Exclusion Criteria: Patients with autoimmune diseases other than MG; Abnormal laboratory results； 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; Acute or chronic infection requiring treatment; Current active hepatitis; HIV antibody positive; Current thymoma-associated immunodeficiency syndrome (Good's syndrome) or thymic surgery within 6 months prior to screening; Received or plan to receive any live vaccine within 3 months prior to randomization; Patients with malignant tumors; Allergy to biological products of human origin; Participation in any clinical trial 28 days prior to randomization or within 5 times the half-life of an investigational drug (whichever is longer); Pregnant or lactating women, and those intending to become pregnant during the trial; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Binghua Xiao
Phone
86-101-58076833
Email
binghua.xiao@remegen.com
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Xuanwu Hospital of Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
State/Province
Gansu
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Zunyi Medical University
City
Zunyi
State/Province
Guizhou
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Recruiting
Facility Name
Nanyang First People's Hospital
City
Nanyang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Name
Inner Mongolia Autonomous Region People's Hospital
City
Huhhot
State/Province
Inner Mongolia
Country
China
Individual Site Status
Recruiting
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangxi Provincial People's Hospital
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Name
China-Japan Union Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Name
Dalian Municipal Central Hospital
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Jinzhou Medical University
City
Jinzhou
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Name
Shengjing Hospital Affiliated to China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Name
The People's Hospital of Liaoning Province
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of PLA Air Force Military Medical University
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Name
Xi'an Hi-tech Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Name
Xianyang Hospital of Yan'an University
City
Xianyang
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Jining No.1 People's Hospital
City
Jining
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Huashan Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Shanxi Bethune Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Name
Shanxi Provincial People's Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of North Sichuan Medical College
City
Nanchong
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Name
First Affiliated Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Name
The First People's Hospital of Yunnan Province
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Name
Sir Run Run Shaw Hospital, affiliated with to Zhejiang University College of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting

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Study of Telitacicept in Generalized Myasthenia Gravis

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