Study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effect of JTE-451 administered for 4 weeks in subjects with active plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
47
Unnamed facility
Surrey, British Columbia, Canada
Unnamed facility
Markham, Ontario, Canada
Unnamed facility
Peterborough, Ontario, Canada
Unnamed facility
Richmond Hill, Ontario, Canada
Unnamed facility
Waterloo, Ontario, Canada
Number of adverse events
Time frame: 4 weeks
Percent change from baseline in the clinical target PLSS
Time frame: Weeks 1, 2, 3 and 4
Percent change from baseline in the clinical target lesion erythema
Time frame: Weeks 1, 2, 3 and 4
Percent change from baseline in the clinical target lesion induration
Time frame: Weeks 1, 2, 3 and 4
Percent change from baseline in the clinical target lesion scaling
Time frame: Weeks 1, 2, 3 and 4
Change from baseline in the clinical target lesion sPGA score
Time frame: Weeks 1, 2, 3 and 4
Number of subjects with clinical target lesion sPGA scores of 0 or 1
Time frame: Week 1
Number of subjects with clinical target lesion sPGA scores of 0 or 1
Time frame: Week 2
Number of subjects with clinical target lesion sPGA scores of 0 or 1
Time frame: Week 3
Number of subjects with clinical target lesion sPGA scores of 0 or 1
Time frame: Week 4
Number of subjects with at least a 2-point improvement in sPGA score
Time frame: Baseline to Week 4
Trough concentration during multiple dosing prior to next dose (Ctrough)
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Time frame: Weeks 1, 2, 3 and 4