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

Launched by CELLCEUTIX CORPORATION · Jul 9, 2015

Keywords

ClinConnect Summary

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 (±...

Gender

ALL

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®.