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

Myasthenia Gravis, Generalized Clinical Trial

— tMG  

Official title:

A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05067348
• Other study ID #: V4.0, 20220410
• Status: Recruiting
• Phase: Phase 2
• Start date: July 21, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: January 2024
• Source: Tang-Du Hospital
• Contact: Ting Chang, MD,PHD
• Phone: +86-29-84778845
• Email: changting1981[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: September 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis
• Myasthenia Gravis, Generalized

Intervention

Drug:
• Tocilizumab Injectable Product
Participants will receive IV tocilizumab

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing
China	Xiangya Hospital Central South University	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Huashan Hospital	Shanghai	Shanghai
China	Tianjin medical university general hospital	Tianjin	Tianjin
China	Tangdu Hospital, The Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quantitative Myasthenia Gravis (QMG) scores.		16 weeks
Secondary	Proportion of subjects with both (1) = 3-point improvement in QMG and (2) lasts =4 weeks		16 weeks
Secondary	Proportion of subjects with both (1) = 2-point improvement in MG-ADL and (2) lasts =4 weeks		16 weeks
Secondary	Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score.		16 weeks
Secondary	Change in Myasthenia Gravis Composite (MGC) score		16 weeks
Secondary	Change in Myasthenia Gravis Quality of Life-15, revised (MGQOL-15r) score.		16 weeks
Secondary	Change in Myasthenia Gravis Impairment Index (MGII) score.		16 weeks
Secondary	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.		16 weeks