Efficacy and Safety of Prurisol Administered Orally for Active Moderate to Severe Chronic Plaque Psoriasis

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Stable Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT02949388

Run by

Innovation Pharmaceuticals, Inc.

People needed

199

Starts

2016-11-01

Expected to finish

2017-12-01

Last updated by the study team

2018-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Use of corticosteroids in the eye or the ear are allowable
• Other systemic treatments for psoriasis within 4 weeks prior to start of study treatment, e.g., retinoids, fumarates
• Any such treatment used to treat a symptom of psoriasis but not the condition itself (e.g., anti-histamines for pruritus) is not restricted
• Photochemotherapy, e.g., Psoralens + UVA phototherapy (PUVA), within 4 weeks prior to start of study treatment
• Phototherapy, e.g., UVA, UVB, within 2 weeks prior to start of study treatment
• Topical treatments that could affect signs and symptoms of psoriasis within 2 weeks prior to start of study treatment, e.g., corticosteroids, vitamin D analogs, retinoids, pimecrolimus, tacrolimus, tars, keratolytics
• Allowable exceptions are: low or least potent (Class 6 or 7) topical corticosteroids for use on face, palms, soles, and intertriginous areas only; tar and salicylic acid preparations/shampoos for use on scalp only; bland emollient for use on any body region
• Past vaccination with live vaccine within 6 weeks prior to start of study treatment, or plans for administration during the study
• Any investigational or experimental therapy or procedure or participation in any interventional trial within 4 weeks or 5 half-lives (whichever is longer) prior to start of study treatment
• Women of child-bearing potential who are not using reliable means of contraception, e.g., abstinence, surgical sterilization (hysterectomy and/or bilateral oophorectomy or partner vasectomy) or tubal ligation, double barrier method, oral/ injected/ implanted/ transdermal hormonal contraception, intrauterine device or intrauterine system, throughout study participation, and for 4 weeks after the end of treatment
• Women of child-bearing potential who are pregnant or nursing (lactating), or planning a pregnancy while participating in the study
• History of any ongoing, chronic or recurrent infectious disease (with the exception of episodic herpes labialis and herpes genitalis, and vaginal yeast infections)
• Evidence of tuberculosis infection as defined by a positive QuantiFERON®-TB Gold In-Tube test (QFT-G) at Screening, or subjects with an indeterminate QFT-G test result with any retest result as indeterminate or positive
• History of either untreated or incompletely treated latent or active tuberculosis infection
• Ongoing or recent history of any non-psoriatic uncontrolled (in the Investigator's medical opinion) systemic disease, including, but not limited to renal, hepatic, hematologic, gastrointestinal, endocrine, metabolic, pulmonary, cardiac, neurologic, or psychiatric disease. (e.g., A past or current history of hypertension that is controlled with diet and/or medications is not exclusionary.)

Where it is running

• 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
• Study Site — Port Orange, Florida, United States
• Clinical Study Site — Tampa, Florida, United States
• Study Site — Savannah, Georgia, United States
• Study Center — Arlington Heights, Illinois, United States
• Clinical Study Site — South Bend, Indiana, United States
• Study Center — Overland Park, Kansas, United States
• Study Site — Louisville, Kentucky, United States
• Clinical Study Site — Clarkston, Michigan, United States
• Clinical Study Site — Clinton Township, Michigan, United States
• Clinical Study Site — St Louis, Missouri, United States
• Study Site — Las Vegas, Nevada, United States
• Clinical Study Site — Portsmouth, New Hampshire, United States
• Clinical Study Site — Berlin, New Jersey, United States
• Clinical Study Site — New York, New York, United States
• Clinical Study Site — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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