Efficacy and Safety of Prurisol Administered Orally for Active Moderate to Severe Chronic Plaque … (NCT02949388) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of Prurisol Administered Orally for Active Moderate to Severe Chronic Plaque Psoriasis
United States199 participantsStarted 2016-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
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
What they're measuring
1
Proportion of participants achieving at least a 75% reduction from baseline in PASI score (PASI75) at Week 12
Timeframe: 12 Weeks
2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
. 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