A Study of Telitacicept in Patients With Ocular Myasthenia Gravis (OMG)

A Phase III Trial of Telitacicept in Patients With Ocular Myasthenia Gravis

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.

Study Overview

• Status: Recruiting
• Conditions: Myasthenia Gravis, Ocular
• Intervention / Treatment: Drug: Placebo; Drug: Telitacicept

Detailed Description

This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of Telitacicept in subjects with Ocular Myasthenia Gravis (OMG). The study will be conducted at multiple centers.

Eligible subjects will be randomized in a 1:1 ratio to one of two treatment arms:

Arm 1: Telitacicept Arm 2: Placebo Randomization will be stratified by two factors: Acetylcholine Receptor (AChR) antibody status (positive vs. negative) and age (<18 years vs. ≥18 years).

Primary Objective:

To evaluate the efficacy of Telitacicept compared to placebo in the treatment of subjects with Ocular Myasthenia Gravis.

Primary Endpoint:

Change from baseline in the Myasthenia Gravis Impairment Index (Patient-Reported Outcomes) [MGII (PRO)] ocular score at Week 24.

Study Population:

A total of approximately 120 subjects will be enrolled.

Intervention:

Subjects will receive either Telitacicept or a matching placebo. The dose will be determined based on the subject's age and body weight at baseline.

The placebo will be identical in appearance to Telitacicept to maintain the blind.

Safety Assessments:

Safety and tolerability will be assessed through the monitoring and recording of adverse events (AEs), serious adverse events (SAEs), vital signs, physical examinations, and regular laboratory tests (hematology, serum chemistry, urinalysis). An independent Data Monitoring Committee (DMC) will be established to monitor the safety of the trial.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Recruiting
      • Beijing Hospital
      • Contact: Jian Yin; Phone Number: +86-10-85138105; Email: m13611177824@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Voluntarily signed the informed consent form.
2. Age 12 to 80 years, inclusive, male or female.
3. Body weight ≥30 kg.
4. Diagnosis of Myasthenia Gravis (MG) with documented clinical features consistent with the disease.
5. Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Type I.
6. On a stable standard-of-care (SOC) treatment regimen.

Exclusion Criteria:

1. Concomitant autoimmune diseases requiring systemic corticosteroid therapy.
2. Clinically significant laboratory abnormalities.
3. Use of other immunosuppressants (not part of the stable SOC) within 1 month prior to randomization.
4. Presence of an acute or chronic infection requiring treatment.
5. Current active hepatitis or history of severe liver disease.
6. Positive for HIV antibodies.
7. Positive for syphilis antibodies (non-specific or specific).
8. Poorly controlled diabetes mellitus, defined as HbA1c >9.0% or fasting blood glucose ≥11.1 mmol/L.
9. Subjects with thymoma (classified as ≤ Stage II for benign and ≥ Stage III for malignant according to the Masaoka staging system) .
10. Presence of uncontrolled chronic degenerative diseases, psychiatric disorders, or neurological diseases other than MG that could interfere with study assessments.
11. 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.).
12. Known allergy to human-derived biological products.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; The placebo contains no active ingredients. To maintain the blind, the placebo matches the active drug in all physical aspects.
Experimental: Telitacicept	Drug: Telitacicept; The dosage is administered based on the subject's age and baseline body weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the MGII (PRO) ocular score	at Week 24	From enrollment to the end of treatment at 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the MGII (PRO + PE) ocular score	at Week 24	From enrollment to the end of treatment at 24 weeks
Change from baseline in the MG-ADL ocular score	at Week 24	From enrollment to the end of treatment at 24 weeks
Change from baseline in the MG Clinical Absolute Score ocular score	at Week 24	From enrollment to the end of treatment at 24 weeks
Change from baseline in the total MGII score	at Week 24	From enrollment to the end of treatment at 24 weeks
Change from baseline in the total MG-ADL score	at Week 24	From enrollment to the end of treatment at 24 weeks
Change from baseline in the MG-QOL15r total score	at Week 24	From enrollment to the end of treatment at 24 weeks
Incidence and severity of adverse events	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	From signing of informed consent until 4 weeks after the last dose.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and proportion of subjects who achieve MSE, defined as an MG-ADL total score of 0 or 1	at Week 24	From enrollment to the end of treatment at 24 weeks
Number and proportion of subjects in each MGFA-PIS category	at Week 24	From enrollment to the end of treatment at 24 weeks
Number and proportion of subjects in each PGI-S and PGI-C category	at Week 24	From enrollment to the end of treatment at 24 weeks

Collaborators and Investigators

• Sponsor: RemeGen Co., Ltd.
• Collaborators: Huashan Hospital; Beijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Neurodegenerative Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Neuromuscular Junction Diseases; Myasthenia Gravis; telitacicept
• Other Study ID Numbers: RC18-C307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No