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OpenTrials
Completed

NCT Number: NCT02412644

Apremilast 30mg Bid With Narrowband UVB in the Treatment of 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

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Key information

Conditions

Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apremilast

Drug

Primary outcomes

  1. 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

  1. Number of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12

    Time frame: 12WEEKS

    Psoriasis Area Severity Score of 75 or greater at week 12

  2. Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36

    Time frame: 36 weeks

    PASI 90 or greater at week 36

  3. Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36

    Time frame: 36 weeks

    PGA score 0 or 1

Sponsors and collaborators

Lead sponsor

Psoriasis Treatment Center of Central New Jersey

Other

Collaborators

  • Celgene

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 9, 2015
Registry last updated
Jan 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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