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New treatment option for Myasthenia Gravis, Ocular
Official title A Study of Telitacicept in Patients With Ocular Myasthenia Gravis (OMG)
ClinicalTrials.gov ID: NCT07249632
What this study is testing
What is Telitacicept?
Telitacicept is an investigational medicine, given as an once-daily, being studied as a potential treatment for myasthenia gravis, ocular.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Telitacicept for the treatment of Ocular Myasthenia Gravis (OMG).Approximately 120 eligible subjects aged 12 to 80 years with a diagnosis of OMG (Myasthenia Gravis Foundation of America [MGFA] Clinical Classification Type I) will be randomized in a 1:1 ratio to receive either Telitacicept or a matching placebo. Subjects must be on a stable standard-of-care therapy and have an MG Impairment Index (PRO) ocular score of ≥6 at screening and baseline.The dose is age and weight based.The primary objective is to evaluate the efficacy of Telitacicept compared to placebo in treating OMG.The primary efficacy endpoint is the change from baseline in the MGII (PRO) ocular score at Week 24.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 80
You may be able to join if
- Voluntarily signed the informed consent form.
- Age 12 to 80 years, inclusive, male or female.
- Body weight ≥30 kg.
- Diagnosis of Myasthenia Gravis (MG) with documented clinical features consistent with the disease.
- Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Type I.
You likely can't join if
- Concomitant autoimmune diseases requiring systemic corticosteroid therapy.
- Clinically significant laboratory abnormalities.
- Use of other immunosuppressants (not part of the stable SOC) within 1 month prior to randomization.
- Presence of an acute or chronic infection requiring treatment.
- Current active hepatitis or history of severe liver disease.
- Positive for HIV antibodies.
See the full eligibility criteria
- Voluntarily signed the informed consent form.
- Age 12 to 80 years, inclusive, male or female.
- Body weight ≥30 kg.
- Diagnosis of Myasthenia Gravis (MG) with documented clinical features consistent with the disease.
- Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Type I.
- On a stable standard-of-care (SOC) treatment regimen.
- Concomitant autoimmune diseases requiring systemic corticosteroid therapy.
- Clinically significant laboratory abnormalities.
- Use of other immunosuppressants (not part of the stable SOC) within 1 month prior to randomization.
- Presence of an acute or chronic infection requiring treatment.
- Current active hepatitis or history of severe liver disease.
- Positive for HIV antibodies.
- Positive for syphilis antibodies (non-specific or specific).
- Poorly controlled diabetes mellitus, defined as HbA1c \>9.0% or fasting blood glucose ≥11.1 mmol/L.
- people with thymoma (classified as ≤ Stage II for benign and ≥ Stage III for malignant according to the Masaoka staging system) .
- Presence of uncontrolled chronic degenerative diseases, psychiatric disorders, or neurological diseases other than MG that could interfere with study assessments.
- Other diseases causing ptosis, peripheral muscle weakness, or diplopia (e.g., Graves' ophthalmopathy, blepharospasm, progressive external ophthalmoplegia, muscular dystrophy, brainstem or cranial nerve lesions, etc.).
- Known allergy to human-derived biological products.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
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, 12 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.