NCT07249632RecruitingPhase 3
A Study of Telitacicept in Patients With Ocular Myasthenia Gravis (OMG)
A Phase III Trial of Telitacicept in Patients With Ocular Myasthenia Gravis
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
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. Secondary endpoints include changes from baseline in other ocular and total scores from MGII, Myasthenia Gravis-Activities of Daily Living (MG-ADL), MG Clinical Absolute Score, and the 15-item Myasthenia Gravis Quality of Life Revised scale (MG-QOL15r). Safety and tolerability will be monitored throughout the study.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 18 Nov 2025
- Start date
- 13 Jan 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- RemeGen Co., Ltd.
- Diseases
- Myasthenia gravis
- NCT number
- NCT07249632
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 120
- From 13 Jan 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant autoimmune diseases requiring systemic corticosteroid therapy.
- Use of other immunosuppressants (not part of the stable SOC) within 1 month prior to randomization.
- Positive for syphilis antibodies (non-specific or specific).
Other illness
- Presence of an acute or chronic infection requiring treatment.
- Current active hepatitis or history of severe liver disease.
- Positive for HIV antibodies.
- Subjects 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.
Lab values
- Clinically significant laboratory abnormalities.
- Poorly controlled diabetes mellitus, defined as HbA1c \>9.0% or fasting blood glucose ≥11.1 mmol/L.
Who the study is looking for
- 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.
Age in the registry: 12 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.