NCT02555826

Trial name or title	Study of the efficacy and safety Of apremilast (CC‐10004), in subjects with moderate plaque psoriasis
Methods	RCT, placebo‐controlled, double‐blind study Date of study: April 2015 ‐ Location: USA Phase 4
Participants	Randomised: 221 participants Inclusion criteria Men or women, ≥ 18 years of age Able to adhere to the study visit schedule and other protocol requirements Diagnosis of chronic plaque psoriasis for ≥ 6 months prior to signing the informed consent Have moderate plaque psoriasis at screening and baseline as defined by: BSA (Body Surface Area) 5% to 10%, and sPGA (Physician's Global Assessment) 3 (moderate) based on a 0 to 5 point scale Must be in general good health (except for psoriasis) as judged by the investigator No prior systemic treatments or biologics for the treatment of psoriatic arthritis, psoriasis Women must have a negative pregnancy test at screening and baseline. Participants must agree to use contraception during the course of the study Exclusion criteria Other than psoriasis, any clinically significant (as determined by the Investigator) major disease that is currently uncontrolled Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study Pregnant or breastfeeding Active substance abuse or a history of substance abuse within 6 months prior to signing the informed consent Malignancy or history of malignancy Topical therapy within 2 weeks of starting trial Use of phototherapy within 4 weeks prior to starting trial Use of any investigational drug within 4 weeks prior to starting trial Prolonged sun exposure or use of tanning booths, which may confound the ability to interpret data from the study Prior treatment with apremilast
Interventions	Intervention Apremilast (30 mg tablets orally twice daily weeks 0‐52) Control intervention Placebo
Outcomes	At week 16, Primary composite outcome Change from baseline in the product of BSA (%) and the sPGA which is considered as the Total Psoriasis Severity Index Secondary outcomes Mean change from baseline in the DLQI PGA 0/1 Treatment Satisfaction Questionnaire for Medication PASI 75
Starting date	Study starting date: 18 September 2015 Study completion date: November 2016
Contact information	Joana Goncalves, MD Celgene Corporation
Notes	Ongoing study