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

Psoriasis Treatment Center of Central New Jersey

Status and phase: Completed; Phase 4

Conditions: Plaque Psoriasis

Treatments: Drug: apremilast

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02412644

AP-CL-PSOR-PI-004893

Details and patient eligibility

About

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

Full description

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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29 participants in 2 patient groups, including a placebo group

Apremilast + apremilast

Active Comparator group

Description:

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

Treatment:

Drug: apremilast

apremilast + placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: apremilast