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

NCT07249632 | Recruiting Phase 3

• 1 other identifier: RC18-C307
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myasthenia Gravis, Ocular

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the MGII (PRO) ocular score

  at Week 24

  From enrollment to the end of treatment at 24 weeks

Secondary Outcomes (7)

• Change from baseline in the MGII (PRO + PE) ocular score

  From enrollment to the end of treatment at 24 weeks

• Change from baseline in the MG-ADL ocular score

  From enrollment to the end of treatment at 24 weeks

• Change from baseline in the MG Clinical Absolute Score ocular score

  From enrollment to the end of treatment at 24 weeks

• Change from baseline in the total MGII score

  From enrollment to the end of treatment at 24 weeks

• Change from baseline in the total MG-ADL score

  From enrollment to the end of treatment at 24 weeks

Other Outcomes (3)

• Number and proportion of subjects who achieve MSE, defined as an MG-ADL total score of 0 or 1

  From enrollment to the end of treatment at 24 weeks

• Number and proportion of subjects in each MGFA-PIS category

  From enrollment to the end of treatment at 24 weeks

• Number and proportion of subjects in each PGI-S and PGI-C category

  From enrollment to the end of treatment at 24 weeks

Study Arms (2)

Telitacicept

EXPERIMENTAL

Drug: Telitacicept

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Telitacicept DRUG

The dosage is administered based on the subject's age and baseline body weight.

Telitacicept

Placebo DRUG

The placebo contains no active ingredients. To maintain the blind, the placebo matches the active drug in all physical aspects.

Placebo

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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.
• On a stable standard-of-care (SOC) treatment regimen.

You may not qualify 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.
• 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.
• 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.

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead
• Huashan Hospital: collaborator
• Beijing Hospital: collaborator

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Myasthenia Gravis

Interventions

telitacicept

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: January 13, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

CN (1)