Apremilast 30mg Bid With Narrowband UVB in the Treatment of Plaque Psoriasis

Study Overview
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Brief Summary
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12 weeks open label with Otezla® and NUVB, followed by 6 month double blind Otezla® (apremilast) or placebo to subjects who obtain PASI 75 at week 12 of phototherapy

Detailed Description
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Primary Objective: To evaluate the effectiveness of Otezla (apremilast®) in promoting maintenance of response in those subjects who obtained PASI-75 at week 12 of phototherapy.

Official Title
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Efficacy and Safety of Combining Apremilast 30mg Bid With Narrowband UVB in the Treatment of Moderate-to-severe Plaque Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: apremilast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet the following criteria to be enrolled in this study: Male or female adult ≥ 18 years of age; Diagnosis of chronic plaque-type Moderate to severe plaque type psoriasis as defined at baseline by: PASI score of 12 or greater, PGA score of 3 or greater BSA affected by plaque-type psoriasis of 10% or greater, Able and willing to give written informed consent prior to performance of any study-related procedures Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in this study: Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and/or guttate psoriasis) or drug induced psoriasis Subjects with previous exposure to apremilast Malignancy or history of malignancy, except for: treated [ie, cured] basal cell or squamous cell in situ skin carcinomas; treated [ie, cured] malignancy with no evidence of recurrence within the previous 5 years.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Apremilast + apremilast<br>apremilast 30mg bid for 12 weeks.followed by apremilast 30 mg bid for 24 weeks | Drug: apremilast<br> <br> |
| Placebo Comparator: apremilast + placebo<br>apremilast 30mg bid for 12 weeks followed by placebo bid for 24 weeks | Drug: apremilast<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36 | Analysis of Psoriasis Area Severity Index Score at week 36 to determine number of subjects who maintained PASI 75 at week 36 | 36weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12 | Psoriasis Area Severity Score of 75 or greater at week 12 | 12WEEKS | 
| Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36 | PASI 90 or greater at week 36 | 36 weeks | 
| Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36 | PGA score 0 or 1 | 36 weeks |