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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50mg of Purisol daily | Active Comparator | 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 |
|
| 100mg of Purisol daily | Active Comparator | One (1) 50 mg tablets of Prurisol and one (1) matching placebo tablet given twice daily (AM and PM) for 84 (± 3) days |
|
| 200mg of Purisol daily | Active Comparator | Two (2) 50 mg tablets of Prurisol given twice daily (AM and PM) for 84 (± 3) days |
|
| Placebo daily | Placebo Comparator | Two (2) placebo tablets given twice daily (AM and PM) for 84 (± 3) days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prurisol | Drug | 50mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Secondary efficacy endpoints are the percentage of subjects in each treatment group with:≥ 2 point improvement in IGA at 28 days | 28 days | |
| The Secondary efficacy endpoints are the percentage of subjects in each treatment group with: ≥ 2 point improvement in IGA at 56 days |
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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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cellceutix Study Center | Huntsville | Alabama | 35801 | United States | ||
| Cellceutix Study Center |
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| Placebo | Drug | Sugar pill designed to match Purisol tablet |
|
|
| 56 Days |
| 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 |
| 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 |
| 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 |
| Encino |
| California |
| 91436 |
| United States |
| Cellceutix Study Center | Coral Gables | Florida | 33134 | United States |
| Cellceutix Study Center | Hialeah | Florida | 33016 | United States |
| Cellceutix Study Center | Kissimmee | Florida | 34741 | United States |
| Cellceutix Study Center | Miami | Florida | 33126 | United States |
| Cellceutix Study Center | Miami | Florida | 33144 | United States |
| Cellceutix Study Center | Pembroke Pines | Florida | 33026 | United States |
| Cellceutix Study Center | Las Vegas | Nevada | 89119 | United States |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000723098 | abacavir hydroxyacetate |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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