Plaque Psoriasis
Conditions
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.
Interventions
DRUGapremilast
Sponsors
Celgene
Psoriasis Treatment Center of Central New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36 | 36weeks | Analysis of Psoriasis Area Severity Index Score at week 36 to determine number of subjects who maintained PASI 75 at week 36 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12 | 12WEEKS | Psoriasis Area Severity Score of 75 or greater at week 12 |
| Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36 | 36 weeks | PASI 90 or greater at week 36 |
| Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36 | 36 weeks | PGA score 0 or 1 |
Countries
United States
Participant flow
Recruitment details
Recruitment May 28 2015-November 2015 through practice database
Participants by arm
| Arm | Count |
|---|---|
| Apremilast + Apremilast apremilast + apremilast 30mg bid after week 12 | 21 |
| Apremilast + Placebo apremilast + Placebo bid after week 12 | 8 |
| Total | 29 |
Baseline characteristics
| Characteristic | Apremilast + Apremilast | Total | Apremilast + Placebo |
|---|---|---|---|
| Age, Continuous | 44 years STANDARD_DEVIATION 22 | 47 years STANDARD_DEVIATION 50 | 55 years STANDARD_DEVIATION 38 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) White | 15 Participants | 21 Participants | 6 Participants |
| Region of Enrollment United States | 21 participants | 29 participants | 8 participants |
| Sex: Female, Male Female | 9 Participants | 12 Participants | 3 Participants |
| Sex: Female, Male Male | 12 Participants | 17 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 13 / 29 | 3 / 8 | 5 / 8 |
| serious Total, serious adverse events | 1 / 29 | 0 / 8 | 1 / 8 |
Outcome results
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
Time frame: 36weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Apremilast + Apremilast | Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36 | 4 participants |
| Apremilast + Placebo | Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36 | 2 participants |
Secondary
Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36
PGA score 0 or 1
Time frame: 36 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Apremilast + Apremilast | Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36 | 1 participants |
| Apremilast + Placebo | Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36 | 0 participants |
Secondary
Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36
PASI 90 or greater at week 36
Time frame: 36 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Apremilast + Apremilast | Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36 | 1 participants |
| Apremilast + Placebo | Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36 | 0 participants |
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
Time frame: 12WEEKS
Population: 22 subjects completed week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Apremilast + Apremilast | Number of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12 | 16 participants |