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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05067348
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Tang-Du Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ting Chang, MD,PHD
Principal Investigator Affiliation	The Second Affiliated Hospital of Air Force Medical University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Myasthenia Gravis, Generalized

Additional Details

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.

Arms & Interventions

Arms

Experimental: Tocilizumab

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

Placebo Comparator: Placebo

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

Interventions

Drug: - Tocilizumab Injectable Product

Participants will receive IV tocilizumab

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing, Beijing, China

Status

Not yet recruiting

Address

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing, 100050

Site Contact

Fudong Shi, MD,PHD

[email protected]

+86-22-60817429

Changsha, Hunan, China

Status

Not yet recruiting

Address

Xiangya Hospital Central South University

Changsha, Hunan, 410008

Site Contact

Huan Yang, MD,PHD

[email protected]

+86-29-84778845

Xi'an, Shaanxi, China

Status

Recruiting

Address

Tangdu Hospital, The Fourth Military Medical University

Xi'an, Shaanxi, 710038

Site Contact

Ting Chang

[email protected]

02984778845

Huashan Hospital, Shanghai, Shanghai, China

Status

Not yet recruiting

Address

Huashan Hospital

Shanghai, Shanghai, 200040

Site Contact

Chongbo Zhao, MD,PHD

[email protected]

86-21-52889999

Chengdu, Sichuan, China

Status

Not yet recruiting

Address

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041

Site Contact

Hongyu Zhou, MD,PHD

[email protected]

+86-29-84778845

Tianjin, Tianjin, China

Status

Not yet recruiting

Address

Tianjin medical university general hospital

Tianjin, Tianjin, 300052

Site Contact

Chao Zhang, MD,PHD

[email protected]

+86-22-60362255

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