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

Plaque Psoriasis Clinical Trial

Official title:

A Randomized, Double Blind, Parallel Group, Placebo Controlled Clinical Study of the Efficacy and Safety of Three Different Daily Dosages of Prurisol Administered Orally to Subjects With Active Mild to Moderate Chronic Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02494479
• Other study ID #: CTIX-PRU-004
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2015
• Last updated: July 18, 2017
• Start date: August 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Cellceutix Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the efficacy and safety of Prurisol using three different oral daily dose regimens administered to subjects with active mild to moderate chronic plaque psoriasis.

Description:

The total duration of study participation for an individual subject is approximately 112 days (16 weeks) consisting of a Screening visit, followed within 21 days by Randomization and a Treatment Period of 84 days, and a Follow-up Period of 28 days after the last day of study drug treatment. A window of ± 3 days will be considered acceptable for conduct of each scheduled visit following the first visit.

This study will require eight (8) scheduled subject visits:

x Visit 1: Screening (Up to Day 21) x Visit 2: Baseline (Day 0) x Visit 3: Day 14 Interim (± 3 days) x Visit 4: Day 28 Interim (± 3 days) x Visit 5: Day 42 Interim (± 3 days) x Visit 6: Day 56 Interim (± 3 days) x Visit 7: Day 84 End of Treatment/Unscheduled/ET (± 3 days) x Visit 8: Day 112 Follow-up (± 3 days)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or non-pregnant female adults aged 18 years with a clinical diagnosis of stable (at least 6 months) plaque psoriasis, not including scalp or intertriginous areas.

• The extent of psoriasis must meet all of the following three (3) criteria:

• Total Body Surface Area (BSA) affected by plaque psoriasis of 10% to 20% inclusive

• Investigator's Global Assessment (IGA) score of the severity of psoriasis of 2 or 3 (5- point ordinal scale)

• Identification of a target psoriatic lesion with a score of 3 on the Target Lesion Assessment scale (5-point ordinal scale) for Scaling. (Other psoriatic lesions may have lower scaling scores.)

• Females of reproductive potential must not be pregnant

• Female subjects with reproductive potential, if sexually active, must agree to use reliable means of contraception

• The subject must agree to avoid prolonged exposure to the sun and avoid the use of tanning booths or other ultraviolet light sources during the study.

• The subject must provide signed and dated written informed consent to participate in the clinical study.

Exclusion Criteria:

• 1. Females of reproductive potential who are not using reliable contraception.

• Presence of any non-psoriatic uncontrolled (in the Investigator's medical opinion) systemic disease. i

• Unstable forms of psoriasis, e.g. guttate, erythrodermic, exfoliative, palmoplantar, nail, or pustular.

• Use within 6 months of biologic treatment for psoriasis

• Use within 24 months of chemotherapy or radiation therapy.

• Use within 2 months of any systemic immunosuppressive therapy.

• Use within 1 month of (1) systemic corticosteroids, (2) systemic antibiotics, (3) systemic antipsoriasis treatments (e.g. methotrexate, corticosporin, hydroxyurea), (4) PUVA therapy, (5) UVB, (6) systemic anti-inflammatory treatment.

• Use within 2 weeks of topical antipsoriasis drugs or topical corticosteroids or topical retinoids.

• Presence of a condition (e.g., history of frequent consumption of substantial quantities of alcohol, or an untreated psychiatric condition) that makes it unlikely that the requirements of the protocol will be completed.

• History of any previous use of a Tumor Necrosis Factor (TNF) blocker or other immunomodulating drug as therapy for psoriasis within the 6 months prior to screening.

• History of any allergic reaction to any formulation of abacavir.

• Previous treatment with any abacavir-containing product, e.g., Ziagen®, Epzicom®, or Trizivir®.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Prurisol
50mg tablet
• Placebo
Sugar pill designed to match Purisol tablet

Locations

Country	Name	City	State
United States	Cellceutix Study Center	Coral Gables	Florida
United States	Cellceutix Study Center	Encino	California
United States	Cellceutix Study Center	Hialeah	Florida
United States	Cellceutix Study Center	Huntsville	Alabama
United States	Cellceutix Study Center	Kissimmee	Florida
United States	Cellceutix Study Center	Las Vegas	Nevada
United States	Cellceutix Study Center	Miami	Florida
United States	Cellceutix Study Center	Miami	Florida
United States	Cellceutix Study Center	Pembroke Pines	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cellceutix Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint will be the percentage of subjects with = 2 point improvement in IGA rating as defined by visual inspections of patient lesions		84 days
Secondary	The Secondary efficacy endpoints are the percentage of subjects in each treatment group with:= 2 point improvement in IGA at 28 days		28 days
Secondary	The Secondary efficacy endpoints are the percentage of subjects in each treatment group with: = 2 point improvement in IGA at 56 days		56 Days
Secondary	The Secondary efficacy endpoints are the percentage of subjects in each treatment group with: =1 point improvement in Scaling Score of Target Lesion at 28 days		28 Days
Secondary	The Secondary efficacy endpoints are the percentage of subjects in each treatment group with: =1 point improvement in Scaling Score of Target Lesion at 56 days		56 Days
Secondary	The Secondary efficacy endpoints are the percentage of subjects in each treatment group with: =1 point improvement in Scaling Score of Target Lesion at 84 days		84 Days