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

Cellceutix

Status and phase: Completed; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: Placebo; Drug: Prurisol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02494479

CTIX-PRU-004

Details and patient eligibility

About

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.

Full 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)

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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®.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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115 participants in 4 patient groups, including a placebo group

50mg of Purisol daily

Active Comparator group

Description:

One (1) 50 mg tablet of Prurisol and one (1) matching placebo tablet given AM and two (2) matching placebo tablets given PM for 84 (± 3) days

Treatment:

Drug: Prurisol

100mg of Purisol daily

Active Comparator group

Description:

One (1) 50 mg tablets of Prurisol and one (1) matching placebo tablet given twice daily (AM and PM) for 84 (± 3) days

Treatment:

Drug: Prurisol

200mg of Purisol daily

Active Comparator group

Description:

Two (2) 50 mg tablets of Prurisol given twice daily (AM and PM) for 84 (± 3) days

Treatment:

Drug: Prurisol

Placebo daily

Placebo Comparator group

Description:

Two (2) placebo tablets given twice daily (AM and PM) for 84 (± 3) days

Treatment:

Drug: Placebo