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

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ClinicalTrials.gov Identifier: NCT02412644
Recruitment Status : Completed
First Posted : April 9, 2015
Results First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: apremilast Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Combining Apremilast 30mg Bid With Narrowband UVB in the Treatment of Moderate-to-severe Plaque Psoriasis
Actual Study Start Date : May 28, 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Apremilast

Arm Intervention/treatment
Active Comparator: Apremilast + apremilast
apremilast 30mg bid for 12 weeks.followed by apremilast 30 mg bid for 24 weeks
Drug: apremilast
Placebo Comparator: apremilast + placebo
apremilast 30mg bid for 12 weeks followed by placebo bid for 24 weeks
Drug: apremilast



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02412644


Locations
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United States, New Jersey
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States, 08520
Sponsors and Collaborators
Psoriasis Treatment Center of Central New Jersey
Celgene
Investigators
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Principal Investigator: Jerry Bagel, MD Psoriasis Treatment Center of Central New Jersey

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Responsible Party: Psoriasis Treatment Center of Central New Jersey
ClinicalTrials.gov Identifier: NCT02412644     History of Changes
Other Study ID Numbers: AP-CL-PSOR-PI-004893
First Posted: April 9, 2015    Key Record Dates
Results First Posted: January 28, 2019
Last Update Posted: January 28, 2019
Last Verified: December 2018
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Thalidomide
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents