The purpose of this study is to explore the safety and tolerability of multiple doses of ASKP1240 compared to placebo and determine Pharmacokinetics and Pharmacodynamics in subjects with moderate to severe psoriasis.
Treatment with ASKP1240 or placebo will be over 4 weeks (Baseline/Day 1, Days 15 and Day 29) with 12 weeks of follow-up for a total of 16 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Specialist Connect
Brisbane, Queensland, Australia
CMAX
Adelaide, Victoria, Australia
Epworth Hospital
Richmond, Victoria, Australia
Pharmacokinetics of ASKP1240: Area under the curve 0-336 (AUC336 )
Time frame: Day 1 to Day 113 (12 visits)
Pharmacokinetics of ASKP1240: Maximum Concentration (Cmax)
Time frame: Day 1 to Day 113 (12 visits)
Pharmacodynamic variable: CD40 receptor occupancy on peripheral blood B cells
Time frame: Day 1 to Day 113 (12 visits)
Characterize safety profile of ASKP1240 through adverse event reporting, vital signs, clinical laboratory evaluations, physical examinations and 12-lead electrocardiograms (ECGs)
Time frame: 113 Days
Mean change from baseline to 8 weeks in Psoriasis Area Severity Index (PASI) score
Time frame: Baseline and 8 weeks
Mean change from baseline to 8 weeks in Physicians Static Global Assessment (PSGA) score
Time frame: Baseline and 8 weeks
Proportion of Subjects Achieving Treatment Success
Success of the treatment of psoriasis is defined as a score of 1 (almost clear) or 0 (clear) as measured by the PSGA
Time frame: 8 weeks
Mean change from baseline to 8 weeks in % Body Surface Area (BSA)
Time frame: Baseline and 8 weeks
Cytokine Concentration
Time frame: Day 1 to Day 113 (9 visits)
Anti-ASKP1240 antibodies
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Linear Research
Nedlands, Western Australia, Australia
Durondel C.P. Inc, The Dermatology Clinic
Moncton, New Brunswick, Canada
New Lab Clinical Research
St. John's, Newfoundland and Labrador, Canada
Ultranova Skincare
Barrie, Ontario, Canada
K. Papp Clinical Research
Waterloo, Ontario, Canada
Innovaderm Research, Inc.
Montreal, Quebec, Canada
Auckland Clinical Studies
Auckland, New Zealand
...and 3 more locations
Time frame: Day 1 to Day 113 (8 visits )
Lymphocyte subset quantitation
Time frame: Day 1 to Day 113 (9 visits)