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RecruitingNCT05067348tMGUpdated May 1, 2025

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

A Phase 2 interventional study of Tocilizumab Injectable Product in Myasthenia Gravis, Generalized, sponsored by Tang-Du Hospital. Recruiting at 6 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-01.

Sponsored by Tang-Du Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Myasthenia Gravis, Generalized

Keywords

  • Generalized Myasthenia Gravis
  • Tocilizumab
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 this score attributed to non-ocular items.
  4. QMG score of 11 or greater.

  5. Subjects must be on:

    1. Cholinesterase inhibitor, with no dose increase within 4 weeks prior to randomization;
    2. 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 to randomization and no dose increase within 4 months prior to randomization.

Exclusion criteria

Exclusion Criteria:

  1. Participants had clinically relevant active infections (such as sepsis, pneumonia, or abscess) or severe infections (resulting in hospitalization or requiring antibiotic treatment) in the 4 weeks before randomization;
  2. Those with a history of high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis;
  3. Human immunodeficiency virus (HIV) infection;
  4. Thymomas that have received thymectomy or planned thymectomy during RCP within 6 months before randomization, or require chemotherapy and/or radiotherapy at any time;
  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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    Tocilizumab

    Participants will receive tocilizumab administered intravenously (IV) on weeks 1,5,9 and 13 of the randomized controlled period.

    Drug: Tocilizumab Injectable Product

  • Placebo comparator
    Placebo

    Participants will receive placebo administered intravenously (IV) on weeks 1,5,9 and 13 of the randomized controlled period.

    Drug: Tocilizumab Injectable Product

Interventions

  • DrugTocilizumab Injectable Product

    Participants will receive IV tocilizumab

05

What researchers measure

Primary outcomes

  1. Change in Quantitative Myasthenia Gravis (QMG) scores.

    Time frame: 16 weeks

Secondary outcomes

  1. Proportion of subjects with both (1) ≥ 3-point improvement in QMG and (2) lasts ≥4 weeks

    Time frame: 16 weeks

  2. Proportion of subjects with both (1) ≥ 2-point improvement in MG-ADL and (2) lasts ≥4 weeks

    Time frame: 16 weeks

  3. Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score.

    Time frame: 16 weeks

  4. Change in Myasthenia Gravis Composite (MGC) score

    Time frame: 16 weeks

  5. Change in Myasthenia Gravis Quality of Life-15, revised (MGQOL-15r) score.

    Time frame: 16 weeks

  6. Change in Myasthenia Gravis Impairment Index (MGII) score.

    Time frame: 16 weeks

  7. Number of participants with treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and treatment-emergent serious adverse events (TESAEs) during the randomized controlled period and open-label period.

    Time frame: 16 weeks

06

Study locations

1 of 6 sites recruiting
  • Beijing Tiantan Hospital, Capital Medical University
    Beijing, Beijing 100050, China
    Not yet recruiting
  • Xiangya Hospital Central South University
    Changsha, Hunan 410008, China
    Not yet recruiting
  • Tangdu Hospital, The Fourth Military Medical University
    Xi'an, Shaanxi 710038, China
    Recruiting
  • Huashan Hospital
    Shanghai, Shanghai 200040, China
    Not yet recruiting
  • West China Hospital of Sichuan University
    Chengdu, Sichuan 610041, China
    Not yet recruiting
  • Tianjin medical university general hospital
    Tianjin, Tianjin 300052, China
    • Chao Zhang, MD,PHD · Contact · +86-22-60362255
    Not yet recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05067348
Lead sponsor
Tang-Du Hospital
Responsible party
Sponsor
First posted
Oct 5, 2021
Start date
Jul 21, 2022
Primary completion
Dec 31, 2025 (estimated)
Completion
Mar 30, 2026 (estimated)
Last update
May 1, 2025

Study contacts

Ting Chang, MD,PHD
Contact
changting1981@163.com
+86-29-84778845
Zhe Ruan
Contact
ruanzhe573291596@126.com
+86-29-84778845
Ting Chang, MD,PHD
study director · The Second Affiliated Hospital of Air Force Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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