This study will evaluate the efficacy, safety, tolerability and pharmacokinetics of JTE-162 administered once daily for 2 weeks in subjects with cryopyrin-associated periodic syndrome (CAPS)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Tablets containing JTE-162
Gordon Sussman Clinical Research Inc.
North York, Ontario, Canada
RECRUITINGChange and percent change from baseline to end of treatment (EOT) in high-sensitivity C-reactive protein (hs-CRP)
Time frame: 2 Weeks
Change and percent change from baseline to EOT in Serum amyloid A (SAA)
Time frame: 2 Weeks
Change and percent change from baseline to EOT in Interleukin (IL)-6
Time frame: 2 Weeks
Change and percent change from baseline to EOT in Key symptom score (KSS)
Time frame: 2 Weeks
Change and percent change from baseline to EOT in Individual symptom score on Daily Health Assessment Form, Second Generation (DHAF2)
Time frame: 2 Weeks
Change and percent change from baseline to EOT in Global assessments of disease activity on DHAF2
Time frame: 2 Weeks
Change and percent change from baseline to EOT in Global CAPS symptom assessment by the Investigator
Time frame: 2 Weeks
Change and percent change from baseline to EOT in Individual CAPS symptom assessment by the Investigator
Time frame: 2 Weeks
Number of adverse events
Time frame: 4 Weeks
JTE-162 post-dose plasma concentrations on Day 1
Time frame: 1 Day
JTE-162 trough plasma concentrations on Days 2, 3 and 4, and at the Week 2 Visit (Day 15±2)
Time frame: Day 2, Day 3, Day 4 and Day 15±2
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