Study of Telitacicept in Generalized Myasthenia Gravis

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

The purpose of this study is to evaluate the efficacy and safety of Telitacicept in the treatment of patients with generalized myasthenia gravis.

Study Overview

• Status: Recruiting
• Conditions: Myasthenia Gravis, Generalized
• Intervention / Treatment: Biological: Telitacicept; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Binghua Xiao; Phone Number: 86-101-58076833; Email: binghua.xiao@remegen.com

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China
      • Recruiting
      • The First Affiliated Hospital of Bengbu Medical College
    • Hefei, Anhui, China
      • Recruiting
      • Anhui Provincial Hospital
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Hospital
    • Beijing, Beijing, China
      • Recruiting
      • Xuanwu Hospital of Capital Medical University
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Fujian Medical University Union Hospital
  • Gansu
    • Lanzhou, Gansu, China
      • Recruiting
      • Lanzhou University Second Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Sun Yat-sen University
  • Guizhou
    • Zunyi, Guizhou, China
      • Recruiting
      • Affiliated Hospital of Zunyi Medical University
  • Hebei
    • Shijiazhuang, Hebei, China
      • Recruiting
      • The Second Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Recruiting
      • The second Affiliated Hospital of Harbin Medical University
  • Henan
    • Nanyang, Henan, China
      • Recruiting
      • Nanyang First People's Hospital
    • Zhengzhou, Henan, China
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Provincial People's Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Wuhan, Hubei, China
      • Recruiting
      • Zhongnan Hospital of Wuhan University
    • Wuhan, Hubei, China
      • Recruiting
      • Renmin Hospital of Wuhan University
    • Wuhan, Hubei, China
      • Recruiting
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Wuhan, Hubei, China
      • Recruiting
      • Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital of Central South University
    • Changsha, Hunan, China
      • Recruiting
      • Third Xiangya Hospital of Central South University
  • Inner Mongolia
    • Huhhot, Inner Mongolia, China
      • Recruiting
      • Inner Mongolia Autonomous Region People's Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Nanjing First Hospital
    • Suzhou, Jiangsu, China
      • Recruiting
      • The First Affiliated Hospital of Soochow University
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Recruiting
      • Jiangxi Provincial People's Hospital
  • Jilin
    • Changchun, Jilin, China
      • Recruiting
      • The First Hospital of Jilin University
    • Changchun, Jilin, China
      • Recruiting
      • China-Japan Union Hospital of Jilin University
  • Liaoning
    • Dalian, Liaoning, China
      • Recruiting
      • The First Affiliated Hospital of Dalian Medical University
    • Dalian, Liaoning, China
      • Recruiting
      • The Second Affiliated Hospital of Dalian Medical University
    • Dalian, Liaoning, China
      • Recruiting
      • Dalian Municipal Central Hospital
    • Jinzhou, Liaoning, China
      • Recruiting
      • The First Affiliated Hospital of Jinzhou Medical University
    • Shenyang, Liaoning, China
      • Recruiting
      • The First Hospital of China Medical University
    • Shenyang, Liaoning, China
      • Recruiting
      • Shengjing Hospital affiliated to China Medical University
    • Shenyang, Liaoning, China
      • Recruiting
      • The People's Hospital of Liaoning Province
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Recruiting
      • The Second Affiliated Hospital of PLA Air Force Military Medical University
    • Xi'an, Shaanxi, China
      • Recruiting
      • Xi'an Hi-tech Hospital
    • Xianyang, Shaanxi, China
      • Recruiting
      • XianYang Hospital OF Yan'an University
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Qilu Hospital of Shandong University
    • Jining, Shandong, China
      • Recruiting
      • Jining No.1 People's Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Huashan Hospital affiliated to Fudan University
  • Shanxi
    • Taiyuan, Shanxi, China
      • Recruiting
      • Shanxi Bethune Hospital
    • Taiyuan, Shanxi, China
      • Recruiting
      • Shanxi Provincial People's Hospital
    • Taiyuan, Shanxi, China
      • Recruiting
      • The First Hospital of Shanxi Medical University
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital, Sichuan University
    • Nanchong, Sichuan, China
      • Recruiting
      • Affiliated Hospital of North Sichuan Medical College
  • Xinjiang
    • Urumqi, Xinjiang, China
      • Recruiting
      • First Affiliated Hospital of Xinjiang Medical University
  • Yunnan
    • Kunming, Yunnan, China
      • Recruiting
      • The First People's Hospital of Yunnan Province
    • Kunming, Yunnan, China
      • Recruiting
      • The Second Affiliated hospital of Kunming Medical University
    • Kunming, Yunnan, China
      • Recruiting
      • The First Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Zhejiang Provincial People's Hospital
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Sir Run Run Shaw Hospital, affiliated with to Zhejiang University College of Medicine
    • Wenzhou, Zhejiang, China
      • Recruiting
      • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telitacicept; Participants will receive subcutaneous Telitacicept 240 mg once a week for a total of 48 doses in addition to MG SoC.	Biological: Telitacicept; Administered as an SC infusion; Other Names: RC18
Placebo Comparator: 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.	Drug: Placebo; Administered as an SC infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: RemeGen Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 12, 2023
• First Submitted That Met QC Criteria: February 12, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Myasthenia Gravis; Autoimmune Diseases; Muscle Weakness
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Neoplasms; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Neoplasms by Site; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Neuromuscular Manifestations; Nervous System Neoplasms; Paraneoplastic Syndromes, Nervous System; Paraneoplastic Syndromes; Neuromuscular Junction Diseases; Muscle Weakness; Myasthenia Gravis
• Other Study ID Numbers: 18C029

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No