Clinical trial NCT02494479: Efficacy and Safety of Prurisol Administered Orally for Active Mild to Moderate Chronic Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Keywords: Psoriasis
Topical Psoriasis
Mild Psoriasis
Moderate Psoriasis
Active Psoriasis
Plaque Psoriasis
Skin Diseases
Lead sponsor: Cellceutix Corporation
Sponsor class: INDUSTRY
First posted: 2015-07-10
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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)

Eligibility criteria: 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®.

Primary outcomes:
measure: 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
timeFrame: 84 days
Secondary outcomes:
measure: The Secondary efficacy endpoints are the percentage of subjects in each treatment group with:≥ 2 point improvement in IGA at 28 days
timeFrame: 28 days
measure: The Secondary efficacy endpoints are the percentage of subjects in each treatment group with: ≥ 2 point improvement in IGA at 56 days
timeFrame: 56 Days
measure: 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
timeFrame: 28 Days
measure: 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
timeFrame: 56 Days
measure: 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
timeFrame: 84 Days
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Cellceutix Study Center
state: Alabama
city: Encino
country: United States
facility: Cellceutix Study Center
state: California
city: Coral Gables
country: United States
facility: Cellceutix Study Center
state: Florida
city: Hialeah
country: United States
facility: Cellceutix Study Center
state: Florida
city: Kissimmee
country: United States
facility: Cellceutix Study Center
state: Florida
city: Miami
country: United States
facility: Cellceutix Study Center
state: Florida
city: Miami
country: United States
facility: Cellceutix Study Center
state: Florida
city: Pembroke Pines
country: United States
facility: Cellceutix Study Center
state: Florida
city: Las Vegas
country: United States
facility: Cellceutix Study Center
state: Nevada
Study officials:
References: