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

Phase 4

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: apremilast

• Registration Number: NCT02412644
• Lead Sponsor: Psoriasis Treatment Center of Central New Jersey

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-02-23
• Study First Submitted QC: 2015-04-08
• Study First Posted: 2015-04-09
• Study Start: 2015-05-28
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Results First Submitted: 2017-03-02
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-28
• Last Update Submitted: 2018-12-28
• Results First Posted: 2019-01-28
• Last Update Posted: 2019-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apremilast + apremilast	apremilast	apremilast 30mg bid for 12 weeks.followed by apremilast 30 mg bid for 24 weeks
apremilast + placebo	apremilast	apremilast 30mg bid for 12 weeks followed by placebo bid for 24 weeks

Primary Outcome Measures

Name	Time	Method
Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36	36weeks	Analysis of Psoriasis Area Severity Index Score at week 36 to determine number of subjects who maintained PASI 75 at week 36

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Psoriasis Treatment Center of Central New Jersey; 🇺🇸 East Windsor, New Jersey, United States