Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis

Last updated: April 28, 2025
Sponsor: Tang-Du Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Polymyositis (Inflammatory Muscle Disease)

Neuropathy

Sarcopenia

Treatment

Tocilizumab Injectable Product

Clinical Study ID

NCT05067348
V4.0, 20220410
  • Ages 18-80
  • All Genders

Study Summary

Randomized, double-blind, placebo-controlled, parallel-group study with optional open-label extension.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of MG with anti-AChRantibody.

  2. MGFA Clinical Classification Class II, III, or IV.

  3. MG-ADL score of 5 or greater at screening and at randomization with > 50% of thisscore attributed to non-ocular items.

  4. QMG score of 11 or greater.

  5. Subjects must be on:

  6. Cholinesterase inhibitor, with no dose increase within 4 weeks prior torandomization;

  7. Corticosteroids, with no dose increase within 4 weeks prior to randomization;or/and c. non-steroidal IST (including azathioprine, mycophenolate mofetil,tacrolimus, cyclosporine A), with continuous use for at least 6 months prior torandomization and no dose increase within 4 months prior to randomization.

Exclusion

Exclusion Criteria:

  1. Participants had clinically relevant active infections (such as sepsis, pneumonia,or abscess) or severe infections (resulting in hospitalization or requiringantibiotic treatment) in the 4 weeks before randomization;

  2. Those with a history of high-risk tuberculosis infection, acquired tuberculosisinfection, and chronic hepatitis;

  3. Human immunodeficiency virus (HIV) infection;

  4. Thymomas that have received thymectomy or planned thymectomy during RCP within 6months before randomization, or require chemotherapy and/or radiotherapy at anytime;

  5. Received rituximab treatment in the past 6 months before randomization;

  6. Received tocilizumab or eculizumab treatment within 3 months before randomization;

  7. Received IVIG or plasma exchange within 4 weeks before randomization;

  8. Unresected thymoma.

  9. History of other tumor diseases.

Study Design

Total Participants: 64
Treatment Group(s): 1
Primary Treatment: Tocilizumab Injectable Product
Phase: 2
Study Start date:
July 21, 2022
Estimated Completion Date:
March 30, 2026

Study Description

This study is a randomized, double-blind, placebo-controlled study, to be conducted at 6 study sites. Approximately 64 subjects will be enrolled. Patients with MG who are positive for anti-AChR antibodies will be enrolled. Patients who do not have anti-AChR or anti-MuSK antibodies will not be enrolled. Patients with MGFA classification II, III, or IV disease, MG-ADL score ≥ 5, QMG score ≥ 11, and use of a corticosteroid and/or non-steroidal immunosuppressant will be included in the study.

All subjects who complete the randomized controlled period will have the option to enroll in a 1-year open-label period.

Connect with a study center

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing 100050
    China

    Site Not Available

  • Xiangya Hospital Central South University

    Changsha, Hunan 410008
    China

    Site Not Available

  • Tangdu Hospital, The Fourth Military Medical University

    Xi'an, Shaanxi 710038
    China

    Active - Recruiting

  • Huashan Hospital

    Shanghai, Shanghai 200040
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Tianjin medical university general hospital

    Tianjin, Tianjin 300052
    China

    Site Not Available

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