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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
29
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
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
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
Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36
PASI 90 or greater at week 36
Time frame: 36 weeks
Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36
PGA score 0 or 1
Time frame: 36 weeks
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