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

NCT02494479 | Completed Phase 2

• 1 other identifier: CTIX-PRU-004
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 9

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.

Conditions

Plaque Psoriasis

Keywords

Psoriasis; Topical Psoriasis; Mild Psoriasis; Moderate Psoriasis; Active Psoriasis; Plaque Psoriasis; Skin Diseases

Outcome Measures

Primary Outcomes (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

  84 days

Secondary Outcomes (5)

• 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

  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

Study Arms (4)

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

Drug: Prurisol

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

Drug: Prurisol

200mg of Purisol daily

ACTIVE COMPARATOR

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

Drug: Prurisol

Placebo daily

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Prurisol DRUG

50mg tablet

Also known as: Purisol, 50mg tablet

100mg of Purisol daily; 200mg of Purisol daily; 50mg of Purisol daily

Placebo DRUG

Sugar pill designed to match Purisol tablet

Also known as: Matching Placebo to Purisol tablet

Placebo daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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®.

Sponsors & Collaborators

• Cellceutix Corporation: lead

Study Sites (9)

Cellceutix Study Center

Huntsville, Alabama, 35801, United States

Location

Cellceutix Study Center

Encino, California, 91436, United States

Location

Cellceutix Study Center

Coral Gables, Florida, 33134, United States

Location

Cellceutix Study Center

Hialeah, Florida, 33016, United States

Location

Cellceutix Study Center

Kissimmee, Florida, 34741, United States

Location

Cellceutix Study Center

Miami, Florida, 33126, United States

Location

Cellceutix Study Center

Miami, Florida, 33144, United States

Location

Cellceutix Study Center

Pembroke Pines, Florida, 33026, United States

Location

Cellceutix Study Center

Las Vegas, Nevada, 89119, United States

Location

MeSH Terms

Conditions

Psoriasis; Skin Diseases

Interventions

abacavir hydroxyacetate; Tablets

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: July 10, 2015
• Study Start: August 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 19, 2017

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)