Exploratory evaluation of pharmacokinetics and safety of KHK4827 in subjects with systemic sclerosis
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
210 mg every 2 weeks (Q2W), subcutaneous (SC) injection
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, Japan
serum KHK4827 concentration
Time frame: Pre-dose, Week 1, 2, 4, 8, 12, 16, 22, 24, 36, 48, 52 and every 24 weeks through study completion until 2025.
Change in modified Rodnan skin score (mRSS) from baseline
mRSS: scored 0(normal), 1(mild), 2(moderate), or 3(severe) per each site, assessed in 17 different body sites, total score=51
Time frame: Pre-dose, Week 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and every 8 weeks through study completion until 2025.
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