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
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Chronic Stable Plaque Psoriasis
- Sponsor
- Innovation Pharmaceuticals, Inc.
- Enrollment
- 199
- Locations
- 3
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Evidence of a personally signed and dated written informed consent to participate in the clinical study
- •Male or non-pregnant female adults at least 18 years of age at time of informed consent
- •Chronic plaque-type psoriasis diagnosed for at least 6 months prior to baseline (at time of first study dose)
- •Moderate to severe plaque psoriasis as defined at baseline by:
- •PASI score of 12 or greater, and
- •Static PGA score of moderate (3) or severe (4), and
- •Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater
- •Candidate for systemic therapy or phototherapy
- •Willing to limit ultraviolet light exposure from sunbathing, use of tanning booths, prolonged outdoor exposure, or from other UV light sources during the study.
- •Willing and able to comply with scheduled visits, study assessments and l laboratory tests, and other study procedures
Exclusion Criteria
- •Positive blood test for HLA-B\*5701 allele
- •Currently have forms of psoriasis other than chronic plaque-type, (e.g., guttate, erythrodermic, exfoliative, palmoplantar, pustular), with the exception of nail psoriasis
- •Evidence of drug-induced psoriasis, e.g., a new onset or current exacerbation of psoriasis from beta-blockers, calcium channel inhibitors, antimalarial drugs or lithium
- •Psoriasis flare or rebound within 4 weeks prior to Screening
- •Active inflammatory diseases other than psoriasis that might confound the evaluation of study treatment on signs and symptoms of psoriasis.
- •. Any of the following prohibited treatments that do not meet the specified minimum washout period:
- •Biologic immunomodulating treatments of brodalumab or ustekinumab within 24 weeks prior to start of study treatment
- •Biologic immunomodulating treatments such as adalimumab, etanercept, infliximab, ixekizumab, secukinumab or certolizumab pegol within 12 weeks prior to start of study treatment
- •Systemic immunomodulating treatments other than biologics within 4 weeks prior to start of study treatment, e.g., oral corticosteroids, injectable corticosteroids (intraarticular, intramuscular, cutaneous/subcutaneous or intravenous), methotrexate, cyclosporine, cyclophosphamide, apremilast
- •Inhaled or intranasal corticosteroids with predominantly local effect (e.g., to treat asthma) are allowable
Arms & Interventions
Placebo
Placebo Comparator: Placebo daily Two (2) placebo capsules given twice daily (AM and PM) for 84 (± 2 days
Intervention: Placebo
300 mg (150 mg BID)
Active Comparator: 300 mg of Prurisol daily One (1) capsule containing 100 mg Prurisol and one (1) capsule containing 50 mg of Prurisol given twice (AM and PM) for 84 (± 2) days
Intervention: 300 mg (150 mg BID)
400 mg (200 mg BID)
Active Comparator: 400 mg of Prurisol daily Two (2) capsule each containing 100 mg Prurisol given twice daily (AM and PM) for 84 (± 2) days
Intervention: 400 mg (200 mg BID)
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 16 Weeks
Reporting of Adverse Events measurements, and reporting of adverse events.
Proportion of participants achieving at least a 75% reduction from baseline in PASI score (PASI75) at Week 12
Time Frame: 12 Weeks
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).
Secondary Outcomes
- Assessment of patient-reported quality of life by the Dermatology Life Quality Index (DLQI)(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(16 Weeks)
- PASI75 response at time points through Week 16(16 Weeks)
- The actual and change from baseline in patient-reported itch severity score(16 weeks)
- Assessment of patient-reported quality of life by the Euro-Qol 5 Dimensions Health State Profile(12 Weeks)
- Assessment of patient-reported quality of life by the Short Form-36 Health Survey (version 2, acute form)(12 Weeks)
- Assessment of Patient Satisfaction with Study Treatment (PSST)(12 Weeks)
- Plasma concentrations of Prurisol(4 Weeks)
- Plasma concentrations of abacavir(Timeframe: 4 weeks)