Plaque PsoriasisPhase 2NCT02494479
Efficacy and Safety of Prurisol Administered Orally for Active Mild to Moderate Chronic Plaque Psoriasis
A Phase 2 study testing Prurisol in people with Plaque Psoriasis, run by Cellceutix Corporation at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Prurisol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2015to May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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 locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Cellceutix Study Center
Coral Gables, Florida, 33134
Cellceutix Study Center
Encino, California, 91436
Cellceutix Study Center
Hialeah, Florida, 33016
Cellceutix Study Center
Huntsville, Alabama, 35801
Cellceutix Study Center
Kissimmee, Florida, 34741
Cellceutix Study Center
Las Vegas, Nevada, 89119
Cellceutix Study Center
Miami, Florida, 33126
Cellceutix Study Center
Miami, Florida, 33144
Cellceutix Study Center
Pembroke Pines, Florida, 33026
About this study
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
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.
Read the 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)
- Conditions
- Plaque Psoriasis
- Being tested
- Prurisol, Placebo
- Keywords
- Psoriasis, Topical Psoriasis, Mild Psoriasis, Moderate Psoriasis, Active Psoriasis, Plaque Psoriasis, Skin Diseases
- Medical subject headings
- Psoriasis, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrurisolDrug
Also called Purisol, 50mg tablet
50mg tablet
PlaceboDrug
Also called Matching Placebo to Purisol tablet
Sugar pill designed to match Purisol tablet
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: Prurisol |
| Placebo daily | Placebo comparator | Two (2) placebo tablets given twice daily (AM and PM) for 84 (± 3) days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 28 days
The Secondary efficacy endpoints are the percentage of subjects in each treatment group with: ≥ 2 point improvement in IGA at 56 days
Measured: 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
Measured: 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
Measured: 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
Measured: 84 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellceutix Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494479
- Sponsor's protocol ID
- CTIX-PRU-004
- Status last verified
- May 2016
- First submitted
- 26 Jun 2015
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02494479
- Acronym / sponsor ID
- CTIX-PRU-004
- Conditions
- Plaque Psoriasis
- Keywords
- Psoriasis, Topical Psoriasis, Mild Psoriasis, Moderate Psoriasis, Active Psoriasis, Plaque Psoriasis, Skin Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Cellceutix CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 50mg of Purisol daily | Active comparator | Drug: PrurisolOne (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 | Drug: PrurisolOne (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 | Drug: PrurisolTwo (2) 50 mg tablets of Prurisol given twice daily (AM and PM) for 84 (± 3) days |
| Placebo daily | Placebo comparator | Drug: PlaceboTwo (2) placebo tablets given twice daily (AM and PM) for 84 (± 3) days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrurisolAlso: Purisol, 50mg tablet50mg tablet | Drug | 100mg of Purisol daily, 200mg of Purisol daily, 50mg of Purisol daily |
| PlaceboAlso: Matching Placebo to Purisol tabletSugar pill designed to match Purisol tablet | Drug | Placebo daily |
Primary outcome
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
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prurisol in people with Plaque Psoriasis, run by Cellceutix Corporation at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.