NCT01232283

Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis.

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 413 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the effects of an experimental (being tested) study drug called apremilast. Apremilast works by lowering some of the chemicals that affect psoriasis and therefore improves the symptoms of psoriasis. The purpose of this study is to test apremilast and compare its effects to placebo (an inactive substance which contains no medicine but is in the same form as the drug). This study will test efficacy (improvement of signs and symptoms) and safety of apremilast in patients with moderate to severe psoriasis.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Apremilast	Apremilast 30mg by mouth (PO) twice a day (BID) for 32 weeks
DRUG	Placebo	Identically matching placebo by mouth BID for first 16 weeks. Placebo participants will be switched to receive apremilast 30 mg BID at Week 16-32.
OTHER	Topical or Phototherapy Therapy	Topical therapies such as low-potency or weak corticosteroids or phototherapies such as light therapy are added for non-responders at Week 32, (\< PASI-50) and added to their treatment regimen. The decision to add these treatments during this phase can only be made at the Week 32 visit.

Timeline

• Start date: 2010-11-22
• Primary completion: 2012-03-15
• Completion: 2016-11-30
• First posted: 2010-11-02
• Last updated: 2022-03-15
• Results posted: 2014-11-05

Locations

46 sites across 9 countries: United States, Austria, Canada, Denmark, France, Germany, Italy, Spain, Switzerland