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Clinical Trials in China / NCT05067348
Recruiting Phase 2

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

NCT05067348 · tracked via the Priya Life Science China tracker
Sponsor
Tang-Du Hospital
Phase
Phase 2
Started
2022-07-21
Last updated
2025-05-01

Condition(s) studied

Myasthenia Gravis, Generalized

Investigational drug(s) / intervention(s)

Tocilizumab Injectable Product

Tocilizumab Injectable Product: Participants will receive IV tocilizumab

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
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: 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.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Beijing Tiantan Hospital, Capital Medical University Beijing Beijing Municipality Not Yet Recruiting
Xiangya Hospital Central South University Changsha Hunan Not Yet Recruiting
Tangdu Hospital, The Fourth Military Medical University Xi'an Shaanxi Recruiting
Huashan Hospital Shanghai Shanghai Municipality Not Yet Recruiting
West China Hospital of Sichuan University Chengdu Sichuan Not Yet Recruiting
Tianjin medical university general hospital Tianjin Tianjin Municipality Not Yet Recruiting

More Tang-Du Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05067348 on ClinicalTrials.gov ↗ ← All trials in China