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Myasthenia Gravis, GeneralizedPhase 3NCT05737160

Study of Telitacicept in Generalized Myasthenia Gravis

A Phase 3 study testing Telitacicept in people with Myasthenia Gravis, Generalized, run by RemeGen Co., Ltd. at 51 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Myasthenia Gravis, Generalized
What is being tested?
Telitacicept
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
114 participants
Where
51 sitesChina
Study dates
28 Mar 2023to 12 Dec 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Patients with autoimmune diseases other than MG;
  • Abnormal laboratory results；
  • Use of immunosuppressants other than standard therapy within 1 month before randomization;
  • Use of biologic agents targeting therapy, such as Rituximab or complement C5 inhibitors, within 6 months before randomization;
  • Use of neonatal Fc receptor (FcRn) antagonists, intravenous immunoglobulin (IVIg), or plasmapheresis within 2 months before randomization;
  • 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;
Show all 17Show fewer
  • Acute or chronic infection requiring treatment;
  • Current active hepatitis;
  • HIV antibody positive;
  • Patients currently suffering from thymoma-associated immunodeficiency syndrome (Good's syndrome) or who underwent thymectomy within 6 months before 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.

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

China51 sites

  • Beijing Hospital

    Beijing, Beijing Municipality

  • Xuanwu Hospital of Capital Medical University

    Beijing, Beijing Municipality

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin

  • The First Hospital of Jilin University

    Changchun, Jilin

  • Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • Xiangya Hospital of Central South University

    Changsha, Hunan

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

  • Dalian Municipal Central Hospital

    Dalian, Liaoning

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong

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

    Hangzhou, Zhejiang

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • Anhui Provincial Hospital

    Hefei, Anhui

  • Inner Mongolia Autonomous Region People's Hospital

    Hohhot, Inner Mongolia

  • Qilu Hospital of Shandong University

    Jinan, Shandong

  • Jining No.1 People's Hospital

    Jining, Shandong

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

  • Lanzhou University Second Hospital

    Lanzhou, Gansu

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan

  • Nanjing First Hospital

    Nanjing, Jiangsu

  • Nanyang First People's Hospital

    Nanyang, Henan

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality

  • Shengjing Hospital Affiliated to China Medical University

    Shenyang, Liaoning

  • The First Hospital of China Medical University

    Shenyang, Liaoning

  • The People's Hospital of Liaoning Province

    Shenyang, Liaoning

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei

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

    Wuhan, Hubei

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

    Wuhan, Hubei

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

    Wuhan, Hubei

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

  • The Second Affiliated Hospital of PLA Air Force Military Medical University

    Xi'an, Shaanxi

  • Xi'an Hi-tech Hospital

    Xi'an, Shaanxi

  • Xianyang Hospital of Yan'an University

    Xianyang, Shaanxi

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Telitacicept, Placebo
Keywords
Myasthenia Gravis, Autoimmune Diseases, Muscle Weakness
Medical subject headings
Myasthenia Gravis, Autoimmune Diseases, Muscle Weakness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelitaciceptBiological

    Also called RC18

    Administered as an SC infusion

  • PlaceboDrug

    Administered as an SC infusion

Study groups in NCT05737160
Study groupRoleWhat they receive
TelitaciceptExperimentalParticipants will receive subcutaneous Telitacicept 240 mg once a week for a total of 48 doses in addition to MG SoC.
Receives: Biological: Telitacicept
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 24

Secondary outcomes (4)

  1. 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.

    Measured: Weeks12, 36, 48

  2. 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).

    Measured: Weeks 12, 24, 36, 48

  3. 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.

    Measured: Weeks 24, 48

  4. 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).

    Measured: Weeks 24, 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2023
  2. Study start28 Mar 2023
  3. Primary completion26 Nov 2024
  4. Study completion12 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05737160
Sponsor's protocol ID
18C029
Status last verified
Oct 2024
First submitted
12 Feb 2023
Last updated
23 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telitacicept in people with Myasthenia Gravis, Generalized, run by RemeGen Co., Ltd. at 51 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in MG-ADL (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05737160.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.

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