This study is designed as a randomized, double blind, parallel group, placebo-controlled trial to study the efficacy and safety of two oral doses of Prurisol administered twice daily for twelve weeks to subjects with moderate to severe chronic plaque psoriasis.
This study is designed as a randomized, double blind, parallel group, placebo-controlled trial to study the efficacy and safety of two oral doses of Prurisol administered twice daily for twelve weeks to subjects with moderate to severe chronic plaque psoriasis. Approximately 189 study participants will be enrolled. Subjects will be randomly assigned to one of three treatment groups in a 3:3:1 randomization ratio, respectively. * Group A (n=81): Prurisol 150 mg bid * Group B (n=81): Placebo * Group C (n=27): Prurisol 200 mg bid Outpatient subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy will be recruited to the study. Study participants are required to have a Psoriasis Area and Severity Index (PASI) score ≥ 12, body surface area involvement ≥ 10%, and a static Physician's Global Assessment (sPGA) of moderate or severe (score of 3 or 4). A subject studied under this clinical protocol will commence with a screening period of up to 4 weeks, a treatment period of 12 weeks, and a follow-up period of 4 weeks ending with an End of Study evaluation. During treatment, subjects will return to the study center every 2 weeks. Efficacy assessments, including physician and patient rated endpoints, will be measured throughout the study. Safety and tolerability will be assessed by ascertainment of AEs and results of clinical laboratory testing, vital signs assessments, and need for concomitant medications. At a subset of sites, blood samples for determination of plasma concentrations of Prurisol (abacavir glycolate) and abacavir, it's metabolite, will be obtained from subjects who consent to provide these samples. At selected sites, for those subjects consenting to photography, standardized digital photographs will be obtained for illustrative purposes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
199
Two capsules (both containing Placebo enclosed) taken twice a day and approximately 12 hours apart
Two capsules (both containing two 50mg tablets enclosed) taken twice a day and approximately 12 hours apart
Two capsules (one containing 50mg tablet and one containing two 50 mg tablets) taken twice a day and approximately 12 hours apart
Proportion of participants achieving at least a 75% reduction from baseline in PASI score (PASI75) at Week 12
The Psoriasis Area and Severity Index (PASI) quantifies the severity of psoriasis based on lesion severity and the percent of body surface area affected. It is a composite assessment, across body regions, reflected in a single score: 0 (no disease) to 72 (maximal disease).
Time frame: 12 Weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Reporting of Adverse Events measurements, and reporting of adverse events.
Time frame: 16 Weeks
Proportion of subjects achieving a static Physician Global Assessment (sPGA) score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline
The static Physician Global Assessment reflects an overall severity of the erythema, induration and scaling across all psoriatic lesions on a 5-point scale, where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.
Time frame: 16 Weeks
PASI75 response at time points through Week 16
The Psoriasis Area and Severity Index (PASI) quantifies the severity of psoriasis based on lesion severity and the percent of body surface area affected. It is a composite assessment, across body regions, reflected in a single score: 0 (no disease) to 72 (maximal disease).
Time frame: 16 Weeks
The actual and change from baseline in patient-reported itch severity score
The severity of itching due to psoriasis will be assessed on a horizontal numeric rating scale, anchored by the terms "No itching" (0) and "Worst possible itching" (10).
Time frame: 16 weeks
Assessment of patient-reported quality of life by the Dermatology Life Quality Index (DLQI)
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Study Site
Glendale, Arizona, United States
Study Center
Hot Springs, Arkansas, United States
Clinical Study Site
Rogers, Arkansas, United States
Study Center
Los Angeles, California, United States
Study Site
Los Angeles, California, United States
Clinical Study Site
Murrieta, California, United States
Clinical Study Site
Oceanside, California, United States
Study Site
Sherman Oaks, California, United States
Study Site
Denver, Colorado, United States
Clinical Study Site
Denver, Colorado, United States
...and 24 more locations
The Dermatology Life Quality Index (DLQI) is a 10-item general dermatology questionnaire that assesses patient health-related quality of life in adult subjects with skin diseases such as psoriasis
Time frame: 16 Weeks
Assessment of patient-reported quality of life by the Short Form-36 Health Survey (version 2, acute form)
The SF-36 is a widely used general health status questionnaire that assesses 8 domains of functional health and well-being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions
Time frame: 12 Weeks
Assessment of patient-reported quality of life by the Euro-Qol 5 Dimensions Health State Profile
The EQ-5D is a generic instrument designed to assess a subject's general health status. The instrument consists of a questionnaire and a visual analog scale (VAS)
Time frame: 12 Weeks
Assessment of Patient Satisfaction with Study Treatment (PSST)
Overall patient satisfaction with study treatment will be assessed on a 7-point rating scale, with response options range from "very dissatisfied" to "very satisfied"
Time frame: 12 Weeks
Plasma concentrations of Prurisol
Measurement of Prurisol (abacavir glycolate) from a subset of subjects in the trial
Time frame: 4 Weeks
Plasma concentrations of abacavir
Measurement of abacavir, a metabolite of Prurisol, from a subset of subjects in the trial
Time frame: Timeframe: 4 weeks