This randomized, double-blind, placebo-controlled trial will carry out to assess the efficacy of GB-0998 in the treatment of the steroid-resistant polymyositis and dermatomyositis based on the changes in manual muscle strength (MMT) scores as primary endpoint, and in addition, to assess the safety of GB-0998.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
26
8 mL (400 mg of GB-0998)/kg per day is intravenously administered for five successive days
8 mL/kg per day is intravenously administered for five successive days
Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, Japan
Changes in manual muscle strength (MMT) scores
Time frame: 8 weeks
Changes in the serum levels of creatine kinase (CK) and total scores of activities of daily living (ADL)
Time frame: 8 weeks
Adverse events and laboratory tests
Time frame: 8 weeks
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