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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02412644
Other study ID # AP-CL-PSOR-PI-004893
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 28, 2015
Est. completion date July 2016

Study information

Verified date December 2018
Source Psoriasis Treatment Center of Central New Jersey
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
apremilast


Locations

Country Name City State
United States Psoriasis Treatment Center of Central New Jersey East Windsor New Jersey

Sponsors (2)

Lead Sponsor Collaborator
Psoriasis Treatment Center of Central New Jersey Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 36weeks
Secondary 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 12WEEKS
Secondary Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36 PASI 90 or greater at week 36 36 weeks
Secondary Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36 PGA score 0 or 1 36 weeks
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