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Clinical Trials/NCT02412644
NCT02412644CompletedPhase 4

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

Psoriasis Treatment Center of Central New Jersey1 site in 1 country29 target enrollmentStarted: May 28, 2015Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
29
Locations
1
Primary Endpoint
Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Apremilast + apremilast

Active Comparator

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

Intervention: apremilast (Drug)

apremilast + placebo

Placebo Comparator

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

Intervention: apremilast (Drug)

Outcomes

Primary Outcomes

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

Time Frame: 36weeks

Analysis of Psoriasis Area Severity Index Score at week 36 to determine number of subjects who maintained PASI 75 at week 36

Secondary Outcomes

  • Number of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12(12WEEKS)
  • Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36(36 weeks)
  • Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36(36 weeks)

Investigators

Sponsor
Psoriasis Treatment Center of Central New Jersey
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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Apremilast 30mg Bid With Narrowband UVB in... | Clinical Trial