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

NCT02949388 | Completed Phase 2

• 1 other identifier: CTIX-PRU-005
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 34

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.

Conditions

Chronic Stable Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• 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).

  12 Weeks

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Reporting of Adverse Events measurements, and reporting of adverse events.

  16 Weeks

Secondary Outcomes (9)

• 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 Dermatology Life Quality Index (DLQI)

  16 Weeks

• Assessment of patient-reported quality of life by the Short Form-36 Health Survey (version 2, acute form)

  12 Weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo Comparator: Placebo daily Two (2) placebo capsules given twice daily (AM and PM) for 84 (± 2 days

Drug: Placebo

300 mg (150 mg BID)

ACTIVE COMPARATOR

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)

400 mg (200 mg BID)

ACTIVE COMPARATOR

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)

Interventions

Placebo DRUG

Two capsules (both containing Placebo enclosed) taken twice a day and approximately 12 hours apart

Placebo

400 mg (200 mg BID) DRUG

Two capsules (both containing two 50mg tablets enclosed) taken twice a day and approximately 12 hours apart

Also known as: Prurisol

400 mg (200 mg BID)

300 mg (150 mg BID) DRUG

Two capsules (one containing 50mg tablet and one containing two 50 mg tablets) taken twice a day and approximately 12 hours apart

Also known as: Prurisol

300 mg (150 mg BID)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Innovation Pharmaceuticals, Inc.: lead

Study Sites (34)

Study Site

Glendale, Arizona, 85308, United States

Location

Study Center

Hot Springs, Arkansas, 71913, United States

Location

Clinical Study Site

Rogers, Arkansas, 72758, United States

Location

Study Center

Los Angeles, California, 90017, United States

Location

Study Site

Los Angeles, California, 90036, United States

Location

Clinical Study Site

Murrieta, California, 92562, United States

Location

Clinical Study Site

Oceanside, California, 92056, United States

Location

Study Site

Sherman Oaks, California, 91403, United States

Location

Study Site

Denver, Colorado, 80209, United States

Location

Clinical Study Site

Denver, Colorado, 80210, United States

Location

Study Site

Port Orange, Florida, 32127, United States

Location

Clinical Study Site

Tampa, Florida, 33609, United States

Location

Study Site

Savannah, Georgia, 31406, United States

Location

Study Center

Arlington Heights, Illinois, 60005, United States

Location

Clinical Study Site

South Bend, Indiana, 46617, United States

Location

Study Center

Overland Park, Kansas, 66215, United States

Location

Study Site

Louisville, Kentucky, 40217, United States

Location

Clinical Study Site

Clarkston, Michigan, 48346, United States

Location

Clinical Study Site

Clinton Township, Michigan, 48038, United States

Location

Clinical Study Site

St Louis, Missouri, 63117, United States

Location

Study Site

Las Vegas, Nevada, 89106, United States

Location

Clinical Study Site

Portsmouth, New Hampshire, 03801, United States

Location

Clinical Study Site

Berlin, New Jersey, 08009, United States

Location

Clinical Study Site

New York, New York, 10012, United States

Location

Clinical Study Site

Portland, Oregon, 97210, United States

Location

Study Site

Johnston, Rhode Island, 02919, United States

Location

Study Center

Austin, Texas, 78759, United States

Location

Clinical Study Site

Houston, Texas, 77004, United States

Location

Clinical Study Site

Pflugerville, Texas, 78660, United States

Location

Clinical Study Site

San Antonio, Texas, 78213, United States

Location

Clinical Study Site

San Antonio, Texas, 78229, United States

Location

Study Site

San Antonio, Texas, 78229, United States

Location

Study Site

Webster, Texas, 77598, United States

Location

Study Center

Charlottesville, Virginia, 22911, United States

Location

MeSH Terms

Interventions

BID protein, human; abacavir hydroxyacetate

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: October 31, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 13, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (34)