Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis

This study will test the clinical effectiveness and safety of apremilast compared with placebo as well as etanercept compared with placebo in the same group of patients with moderate to severe plaque psoriasis.

Apremilast (CC-10004) is a new oral agent that is under clinical development for the treatment of inflammatory autoimmune disorders, such as psoriatic arthritis, psoriasis, rheumatoid arthritis, and Behçet disease.

Etanercept is approved for the treatment of psoriasis; it is the most widely prescribed anti-tumor necrosis factor (TNF) for psoriasis.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3b, Multicenter, Randomized, Placebo-Controlled, Double Blind, Double-Dummy, Study of the Efficacy and Safety of Apremilast (CC-10004), Etanercept, and Placebo, in Subjects With Moderate to Severe Plaque Psoriasis
Enrollment: 250
Study Start Date: October 2012
Estimated Study Completion Date: April 2016
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Apremilast 30 mg plus placebo injection
- Experimental: Etanercept 50 mg plus placebo tablet
- Placebo Comparator: Placebo