Authorised Therapeutic confirmatory (Phase III) Generalized Myasthenia Gravis

A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis

EU CTIS ID: 2024-512126-29-00

What this study is testing

To evaluate the efficacy of telitacicept versus placebo in patients with generalized myasthenia gravis (gMG)

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Patients must provide signed informed consent to participate in the study and agreed to compliant with the study procedure.
2. Male or female patient aged ≥18 years at screening.
3. Patients have prior confirmed diagnosis of gMG with generalized muscle weakness (typical pattern of weakness, eg, predominantly proximal, fatigable, fluctuating in severity, more severe in the evening, and improved with rest) meeting the clinical criteria for diagnosis of MG as defined by the Myasthenia Gravis Foundation of America (MGFA) clinical classification II-IV. Patient’s diagnosis should meet at least 1 of the following tests: a. History of abnormal neuromuscular transmission demonstrated by single fiber electromyography or repetitive nerve stimulation, OR b. History of positive edrophonium chloride test, OR c. Improvement in MG signs on oral acetylcholine esterase (AChE) inhibitors as assessed by the treating physician.
4. Patients have positive antibodies against AChR or MuSK at screening.
5. MG‐ADL score ≥6 points at screening and baseline with ocular-related score <50% of the total score.
6. QMG score ≥ 8 points, and ≥ 4 items score at least 2 points at screening and baseline

You likely can't join if

1. Patients have been diagnosed with any other autoimmune disease(s), eg, rheumatoid arthritis, Sjogren’s syndrome, which can potentially pose a safety or efficacy confounding risk. Note: Patients with abnormal thyroid function at screening will be excluded from the study. However, patients with a documented history of hypothyroidism or hyperthyroidism who have been adequately treated and whose laboratory results are within the normal range at screening can be included.
10. Patients have current or history of primary immunodeficiency.
11. Patients have history of malignancy within the last 5 years, except for adequately treated nonmelanoma skin cancer (eg, basal or squamous cell carcinoma) or carcinoma in situ of the cervix.
12. Patient have prior or continuing diagnosis of serious cardiovascular disease(s) (including severe arrhythmias), liver, kidney, respiratory system, endocrine (eg, poorly controlled type I or type IIdiabetes mellitus, defined as glycosylated hemoglobin A1c [HbA1c] >8%), or hematologic disease(s), or other medical conditions that, in the opinion of the investigator, Medical Monitor, and/or Study Sponsor, could reasonably prevent the patient from safely participating in the study or from compliance to study procedures.
13. Patients have a known allergy to human biological products or any of the listed excipients.
14. Patients are currently dependent on alcohol/drugs (including marijuana) or have a history of alcohol/drug (including marijuana) dependence or addiction that, in the opinion of the investigator, may adversely affect patient safety or prevent patient compliance with study procedures.

See the full eligibility criteria

Who can join

1. Patients must provide signed informed consent to participate in the study and agreed to compliant with the study procedure.
2. Male or female patient aged ≥18 years at screening.
3. Patients have prior confirmed diagnosis of gMG with generalized muscle weakness (typical pattern of weakness, eg, predominantly proximal, fatigable, fluctuating in severity, more severe in the evening, and improved with rest) meeting the clinical criteria for diagnosis of MG as defined by the Myasthenia Gravis Foundation of America (MGFA) clinical classification II-IV. Patient’s diagnosis should meet at least 1 of the following tests: a. History of abnormal neuromuscular transmission demonstrated by single fiber electromyography or repetitive nerve stimulation, OR b. History of positive edrophonium chloride test, OR c. Improvement in MG signs on oral acetylcholine esterase (AChE) inhibitors as assessed by the treating physician.
4. Patients have positive antibodies against AChR or MuSK at screening.
5. MG‐ADL score ≥6 points at screening and baseline with ocular-related score <50% of the total score.
6. QMG score ≥ 8 points, and ≥ 4 items score at least 2 points at screening and baseline
7. Up to 2 concomitant medications (with the exception of cholinesterase inhibitors) for the treatment of MG are permitted if they meet the stability criteria prior to baseline
8. Patients agree to use highly effective contraception
9. Patients are appropriately vaccinated (e.g., vaccinations for pneumococcus, influenza, and COVID-19) per investigator's clinical judgement considering the patient's risk factors and according to country and local guidelines. Meningococcal vaccination is not required prior to initiating treatment with telitacicept

What rules you out

1. Patients have been diagnosed with any other autoimmune disease(s), eg, rheumatoid arthritis, Sjogren’s syndrome, which can potentially pose a safety or efficacy confounding risk. Note: Patients with abnormal thyroid function at screening will be excluded from the study. However, patients with a documented history of hypothyroidism or hyperthyroidism who have been adequately treated and whose laboratory results are within the normal range at screening can be included.
10. Patients have current or history of primary immunodeficiency.
11. Patients have history of malignancy within the last 5 years, except for adequately treated nonmelanoma skin cancer (eg, basal or squamous cell carcinoma) or carcinoma in situ of the cervix.
12. Patient have prior or continuing diagnosis of serious cardiovascular disease(s) (including severe arrhythmias), liver, kidney, respiratory system, endocrine (eg, poorly controlled type I or type IIdiabetes mellitus, defined as glycosylated hemoglobin A1c [HbA1c] >8%), or hematologic disease(s), or other medical conditions that, in the opinion of the investigator, Medical Monitor, and/or Study Sponsor, could reasonably prevent the patient from safely participating in the study or from compliance to study procedures.
13. Patients have a known allergy to human biological products or any of the listed excipients.
14. Patients are currently dependent on alcohol/drugs (including marijuana) or have a history of alcohol/drug (including marijuana) dependence or addiction that, in the opinion of the investigator, may adversely affect patient safety or prevent patient compliance with study procedures.
15. History of a suicidal attempt within the past 12 months, or current suicidal, intent or behavior during the screening period according to the Columbia suicide severity rating scales (C-SSRS).
16. Women who are currently breastfeeding or intend to breastfeed during the study period.
2. Patients have abnormal laboratory parameters at screening
3. Patients have received prohibited immunosuppressants other than protocol permitted stable concomitant medication (per Inclusion Criterion 7, see protocol Table 7), biologics or other agents with protocol defined time period prior to randomization.
4. Patients have received intravenous immunoglobulin or plasma exchange therapy ≤4 weeks before randomization.
5. Patients have received live or attenuated vaccine ≤4 weeks prior to screening or during the study.
6. Patients have participated in any interventional clinical trial or received an investigational treatment ≤3 months or within a period of 5 times of study drug’s half-life (whichever is longer).
7. Patients have acute or chronic infection prior to randomization.
8. Patients receiving treatment for any chronic infection (eg, tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, atypical mycobacterium, etc).
9. Patients have thymoma within 5 years or have received thymectomy ≤6 months prior to screening.

The study team makes the final eligibility decision.

Where it's taking place

Georgia
United States
Brazil
Canada
Australia
Argentina
China
Japan

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Georgia; United States; Brazil; Canada; Australia; Argentina and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.