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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02494479
Recruitment Status : Completed
First Posted : July 10, 2015
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Cellceutix Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Prurisol Drug: Placebo Phase 2

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)

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 50mg of Purisol daily
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
 Drug: Prurisol
50mg tablet
Other Name: Purisol, 50mg tablet
Active Comparator: 100mg of Purisol daily
One (1) 50 mg tablets of Prurisol and one (1) matching placebo tablet given twice daily (AM and PM) for 84 (± 3) days
 Drug: Prurisol
50mg tablet
Other Name: Purisol, 50mg tablet
Active Comparator: 200mg of Purisol daily
Two (2) 50 mg tablets of Prurisol given twice daily (AM and PM) for 84 (± 3) days
 Drug: Prurisol
50mg tablet
Other Name: Purisol, 50mg tablet
Placebo Comparator: Placebo daily
Two (2) placebo tablets given twice daily (AM and PM) for 84 (± 3) days
 Drug: Placebo
Sugar pill designed to match Purisol tablet
Other Name: Matching Placebo to Purisol tablet


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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®.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494479


Locations
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United States, Alabama
Cellceutix Study Center
Huntsville, Alabama, United States, 35801
United States, California
Cellceutix Study Center
Encino, California, United States, 91436
United States, Florida
Cellceutix Study Center
Coral Gables, Florida, United States, 33134
Cellceutix Study Center
Hialeah, Florida, United States, 33016
Cellceutix Study Center
Kissimmee, Florida, United States, 34741
Cellceutix Study Center
Miami, Florida, United States, 33126
Cellceutix Study Center
Miami, Florida, United States, 33144
Cellceutix Study Center
Pembroke Pines, Florida, United States, 33026
United States, Nevada
Cellceutix Study Center
Las Vegas, Nevada, United States, 89119
Sponsors and Collaborators
Cellceutix Corporation
More Information
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Responsible Party: Cellceutix Corporation
ClinicalTrials.gov Identifier: NCT02494479    
Other Study ID Numbers: CTIX-PRU-004
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cellceutix Corporation:
Psoriasis
Topical Psoriasis
Mild Psoriasis
Moderate Psoriasis
 Active Psoriasis
Plaque Psoriasis
Skin Diseases
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases