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

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
apremilast
Sponsored by
Psoriasis Treatment Center of Central New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Psoriasis Treatment Center of Central New Jersey

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Apremilast + apremilast

apremilast + placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36
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

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

Full Information

First Posted
February 23, 2015
Last Updated
December 28, 2018
Sponsor
Psoriasis Treatment Center of Central New Jersey
Collaborators
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT02412644
Brief Title
Apremilast 30mg Bid With Narrowband UVB in the Treatment of Plaque Psoriasis
Official Title
Efficacy and Safety of Combining Apremilast 30mg Bid With Narrowband UVB in the Treatment of Moderate-to-severe Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 28, 2015 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Psoriasis Treatment Center of Central New Jersey
Collaborators
Celgene

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apremilast + apremilast
Arm Type
Active Comparator
Arm Description
apremilast 30mg bid for 12 weeks.followed by apremilast 30 mg bid for 24 weeks
Arm Title
apremilast + placebo
Arm Type
Placebo Comparator
Arm Description
apremilast 30mg bid for 12 weeks followed by placebo bid for 24 weeks
Intervention Type
Drug
Intervention Name(s)
apremilast
Primary Outcome Measure Information:
Title
Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36
Description
Analysis of Psoriasis Area Severity Index Score at week 36 to determine number of subjects who maintained PASI 75 at week 36
Time Frame
36weeks
Secondary Outcome Measure Information:
Title
Number of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12
Description
Psoriasis Area Severity Score of 75 or greater at week 12
Time Frame
12WEEKS
Title
Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36
Description
PASI 90 or greater at week 36
Time Frame
36 weeks
Title
Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36
Description
PGA score 0 or 1
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must meet the following criteria to be enrolled in this study: Male or female adult ≥ 18 years of age; Diagnosis of chronic plaque-type 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, 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: Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and/or guttate psoriasis) or drug induced psoriasis Subjects with previous exposure to apremilast 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry Bagel, MD
Organizational Affiliation
Psoriasis Treatment Center of Central New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psoriasis Treatment Center of Central New Jersey
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States

12. IPD Sharing Statement

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

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