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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-28

Study Completion Date

2016-07-31

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

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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.

Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Apremilast + apremilast

apremilast 30mg bid for 12 weeks.followed by apremilast 30 mg bid for 24 weeks

Group Type ACTIVE_COMPARATOR

apremilast

Intervention Type DRUG

apremilast + placebo

apremilast 30mg bid for 12 weeks followed by placebo bid for 24 weeks

Group Type PLACEBO_COMPARATOR

apremilast

Intervention Type DRUG

Interventions

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apremilast

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female adult ≥ 18 years of age;
2. Diagnosis of chronic plaque-type
3. 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,
4. 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:

1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and/or guttate psoriasis) or drug induced psoriasis
2. Subjects with previous exposure to apremilast
3. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No