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



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:1/30/2019
Start Date:May 28, 2015
End Date:July 2016

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

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

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.

Inclusion Criteria: Subjects must meet the following criteria to be enrolled in this study:

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.
We found this trial at
1
site
59 One Mile Road
East Windsor, New Jersey 08520
609-443-4500
Principal Investigator: Jerry Bagel, MD
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mi
from
East Windsor, NJ
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