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 |
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
(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.
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
East Windsor, New Jersey 08520
609-443-4500
Principal Investigator: Jerry Bagel, MD
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