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

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Prurisol
Placebo
Sponsored by
Cellceutix Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring Psoriasis, Topical Psoriasis, Mild Psoriasis, Moderate Psoriasis, Active Psoriasis, Plaque Psoriasis, Skin Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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®.

Sites / Locations

  • Cellceutix Study Center
  • Cellceutix Study Center
  • Cellceutix Study Center
  • Cellceutix Study Center
  • Cellceutix Study Center
  • Cellceutix Study Center
  • Cellceutix Study Center
  • Cellceutix Study Center
  • Cellceutix Study Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

50mg of Purisol daily

100mg of Purisol daily

200mg of Purisol daily

Placebo daily

Arm 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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The Secondary efficacy endpoints are the percentage of subjects in each treatment group with:≥ 2 point improvement in IGA at 28 days
The Secondary efficacy endpoints are the percentage of subjects in each treatment group with: ≥ 2 point improvement in IGA at 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
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
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

Full Information

First Posted
June 26, 2015
Last Updated
July 18, 2017
Sponsor
Cellceutix Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02494479
Brief Title
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cellceutix Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
Psoriasis, Topical Psoriasis, Mild Psoriasis, Moderate Psoriasis, Active Psoriasis, Plaque Psoriasis, Skin Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
50mg of Purisol daily
Arm Type
Active Comparator
Arm 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
Arm Title
100mg of Purisol daily
Arm Type
Active Comparator
Arm Description
One (1) 50 mg tablets of Prurisol and one (1) matching placebo tablet given twice daily (AM and PM) for 84 (± 3) days
Arm Title
200mg of Purisol daily
Arm Type
Active Comparator
Arm Description
Two (2) 50 mg tablets of Prurisol given twice daily (AM and PM) for 84 (± 3) days
Arm Title
Placebo daily
Arm Type
Placebo Comparator
Arm Description
Two (2) placebo tablets given twice daily (AM and PM) for 84 (± 3) days
Intervention Type
Drug
Intervention Name(s)
Prurisol
Other Intervention Name(s)
Purisol, 50mg tablet
Intervention Description
50mg tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matching Placebo to Purisol tablet
Intervention Description
Sugar pill designed to match Purisol tablet
Primary Outcome Measure Information:
Title
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
Time Frame
84 days
Secondary Outcome Measure Information:
Title
The Secondary efficacy endpoints are the percentage of subjects in each treatment group with:≥ 2 point improvement in IGA at 28 days
Time Frame
28 days
Title
The Secondary efficacy endpoints are the percentage of subjects in each treatment group with: ≥ 2 point improvement in IGA at 56 days
Time Frame
56 Days
Title
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
Time Frame
28 Days
Title
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
Time Frame
56 Days
Title
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
Time Frame
84 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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®.
Facility Information:
Facility Name
Cellceutix Study Center
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Cellceutix Study Center
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Cellceutix Study Center
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Cellceutix Study Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Cellceutix Study Center
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Cellceutix Study Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Cellceutix Study Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Cellceutix Study Center
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Cellceutix Study Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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