Study of Telitacicept in Generalized Myasthenia Gravis

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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. 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05737160
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	RemeGen Co., Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Myasthenia Gravis, Generalized

Additional Details

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.

Arms & Interventions

Arms

Experimental: Telitacicept

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

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.

Interventions

Biological: - Telitacicept

Administered as an SC infusion

Drug: - Placebo

Administered as an SC infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Bengbu, Anhui, China

Status

Recruiting

Address

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui,

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