Clinical trial
A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis
Name
V4.0, 20220410
Description
Randomized, double-blind, placebo-controlled, parallel-group study with optional open-label extension.
Trial arms
Trial start
2022-07-21
Estimated PCD
2024-03-31
Trial end
2024-09-30
Status
Recruiting
Phase
Early phase I
Treatment
Tocilizumab Injectable Product
Participants will receive IV tocilizumab
Arms:
Placebo, Tocilizumab
Size
64
Primary endpoint
Change in Quantitative Myasthenia Gravis (QMG) scores.
16 weeks
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 64, 'type': 'ESTIMATED'}}
Updated at
2024-01-23
1 organization
1 product
2 indications
Organization
Tang-Du HospitalProduct
TocilizumabIndication
Myasthenia GravisIndication
Generalized