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Treatment of generalized myasthenia gravis with telitacicept

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study With an Open-label Extension Period to Evaluate the Efficacy and Safety of Telitacicept in Patients With Generalized Myasthenia Gravis

PHASE3 · Vor Biopharma · NCT06456580

This study is testing if a new treatment called telitacicept can help people with generalized myasthenia gravis feel stronger and manage their symptoms better.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years and up
SexAll
SponsorVor Biopharma (industry)
Locations105 sites (Los Angeles, California and 104 other locations)
Trial IDNCT06456580 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of telitacicept, a fully human TACI-Fc fusion protein, in treating generalized myasthenia gravis (gMG). Myasthenia gravis is an autoimmune disease characterized by muscle weakness that worsens with exertion. The study is a randomized, double-blind, placebo-controlled Phase 3 trial with an open-label extension, aiming to assess how telitacicept can inhibit B-cell proliferation and alleviate autoimmune symptoms in a global patient population. Participants will be monitored for improvements in muscle strength and overall disease management.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of generalized myasthenia gravis and specific antibody positivity.

Not a fit: Patients with other autoimmune diseases, acute infections, or recent thymectomy may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve muscle strength and quality of life for patients with generalized myasthenia gravis.

How similar studies have performed: Other studies targeting B-cell modulation in autoimmune diseases have shown promise, suggesting potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Male or female patient aged ≥18 years at screening.
2. Patients have prior confirmed diagnosis of gMG with generalized muscle weakness (typical pattern of weakness meeting the clinical criteria for diagnosis of MG as defined by the Myasthenia Gravis Foundation of America (MGFA) clinical classification II-IV.
3. Patients have positive antibodies against AChR or MuSK at screening.
4. MG-ADL score ≥6 points at screening and baseline with ocular-related score \<50% of the total score.
5. QMG score ≥8 points, and ≥ 4 items score at least 2 points at screening and baseline.

Key Exclusion Criteria:

1. Patients have been diagnosed with any other autoimmune disease which can potentially pose a safety or efficacy confounding risk.
2. Patients having acute or chronic infection.
3. Patients having thymoma within 5 years or received thymectomy ≤6 months prior to screening. Patients with thymoma diagnosed 3-5 years prior to screening may be eligible if thymoma was at a localized stage and definitively treated with complete surgical resection.
4. Patients having current or history of primary immunodeficiency.
5. Patients having history of malignancy within the last 5 years.
6. Patient having prior or continuing diagnosis of serious cardiovascular, liver, kidney, respiratory system, endocrine or hematologic disease.

Where this trial is running

Los Angeles, California and 104 other locations

+55 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Generalized Myasthenia Gravis, Myasthenia Gravis, gMG

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.