The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of 12 weeks of treatment with Apo805K1 in subjects with moderate to severe chronic plaque psoriasis.
A) To evaluate the safety and tolerability of 12 weeks of treatment with Apo805K1 B) To evaluate the pharmacokinetics of Apo805K1 following daily administration for 14 days C) To evaluate the efficacy and pharmacodynamics of Apo805K1
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Sequential parallel dose escalation.
Axis Clinical Trials
Los Angeles, California, United States
Axis Clinical Trials
Los Angeles, California, United States
Menter Dermatology Research Institute
Dallas, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Number of Patients With Adverse Events
The number of patients in each treatment group who reported at least 1 adverse event, including clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations and laboratory tests, from the time of the first dose until the last study visit.
Time frame: 12 Weeks
Cmax of Apo805K1 Following Multiple Doses, Assessed at Day 14
Cmax for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose. .
Time frame: 12 hours
Tmax of Apo805K1 Following Multiple Doses, Assessed at Day 14
Tmax for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.
Time frame: 12 hours
AUC 0-infinity of Apo805K1 Following Multiple Doses, Assessed at Day 14
AUC 0-infinity for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.
Time frame: 12 hours
T 1/2 of Apo805K1 Following Multiple Doses, Assessed at Day 14
T 1/2 for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.
Time frame: 12 hours
Efficacy of Apo805K1 as Assessed by Change From Baseline in Psoriasis Area Severity Index (PASI) Scores
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Center for Clinical Studies
Houston, Texas, United States
The University of Utah
Salt Lake City, Utah, United States
Innovaderm Research Inc.
Montreal, Quebec, Canada
PASI is a quantitative measure of psoriasis that combines an assessment of the severity of lesions and a measurement of how much of the body surface area is affected into a single score ranging from 0 (no disease) to 72 (maximal disease). Thus, a decrease in PASI score indicates improvement. This outcome measure compared the difference in change in PASI score from baseline to Week 12 between the active treatment groups and the placebo group.
Time frame: Baseline to 12 Weeks
Efficacy of APO805K1 as Assessed by Achievement of PASI-75
The proportion of patients in each treatment group who achieved at least a 75% improvement in PASI score from baseline at Week 12
Time frame: 12 weeks
Efficacy of Apo805K1 as Assessed by Change From Baseline at Week 12 in Lattice System-Physician Global Assessment (LS-PGA) Scores
The LS-PGA is a standardized method for determining categories of psoriasis severity. The percentage of body surface area involved is assessed on a scale ranging from 1 (0%) to 7 (51-100%); measures of plaque severity (thickness, erythema, and scaling) are assessed using a 4-point scale ranging from "none" to "marked"; and an algorithm is used to combine the above scores to determine a final score on a scale ranging from 0 (clear) to 7 (very severe). Thus, a decrease in LS-PGA score indicates improvement. This outcome measure compared the difference in change in LS-PGA score from baseline to Week 12 between the active treatment groups and the placebo group.
Time frame: Baseline to 12 weeks
Efficacy of Apo805K1 as Assessed by Change From Baseline to Week 12 in Physician Global Assessment (PGA) Score
In the PGA, the physician assigns a single estimate of a patient's overall severity of the disease using a scale ranging from 0 (Clear) to 7 (Severe). (Unlike the LS-PGA, the individual elements of psoriasis plaque morphology or degree of body surface area involvement are not quantified.) Thus, a decrease in PGA score indicates improvement. This outcome measure compared the difference in change in PGA score from baseline to Week 12 between the active treatment groups and the placebo group.
Time frame: Baseline to 12 weeks