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Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05067348
Study type Interventional
Source Tang-Du Hospital
Contact Ting Chang, MD,PHD
Phone +86-29-84778845
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date October 8, 2021
Completion date September 30, 2024

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