Efficacy and Safety of Prurisol Administered Orally for Active Moderate to Severe Chronic Plaque Psoriasis
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|ClinicalTrials.gov Identifier: NCT02949388|
Recruitment Status : Completed
First Posted : October 31, 2016
Last Update Posted : February 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Stable Plaque Psoriasis||Drug: Placebo Drug: 400 mg (200 mg BID) Drug: 300 mg (150 mg BID)||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||199 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||November 2016|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||December 2017|
Placebo Comparator: Placebo
Placebo Comparator: Placebo daily Two (2) placebo capsules given twice daily (AM and PM) for 84 (± 2 days
Two capsules (both containing Placebo enclosed) taken twice a day and approximately 12 hours apart
Active Comparator: 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
Drug: 300 mg (150 mg BID)
Two capsules (one containing 50mg tablet and one containing two 50 mg tablets) taken twice a day and approximately 12 hours apart
Other Name: Prurisol
Active Comparator: 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
Drug: 400 mg (200 mg BID)
Two capsules (both containing two 50mg tablets enclosed) taken twice a day and approximately 12 hours apart
Other Name: Prurisol
- 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).
- 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 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 [ Time Frame: 16 Weeks ]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.
- PASI75 response at time points through Week 16 [ Time Frame: 16 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).
- The actual and change from baseline in patient-reported itch severity score [ Time Frame: 16 weeks ]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).
- Assessment of patient-reported quality of life by the Dermatology Life Quality Index (DLQI) [ Time Frame: 16 Weeks ]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
- Assessment of patient-reported quality of life by the Short Form-36 Health Survey (version 2, acute form) [ Time Frame: 12 Weeks ]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
- Assessment of patient-reported quality of life by the Euro-Qol 5 Dimensions Health State Profile [ Time Frame: 12 Weeks ]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)
- Assessment of Patient Satisfaction with Study Treatment (PSST) [ Time Frame: 12 Weeks ]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"
- Plasma concentrations of Prurisol [ Time Frame: 4 Weeks ]Measurement of Prurisol (abacavir glycolate) from a subset of subjects in the trial
- Plasma concentrations of abacavir [ Time Frame: Timeframe: 4 weeks ]Measurement of abacavir, a metabolite of Prurisol, from a subset of subjects in the trial
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02949388