NCT01988103

Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Patients With Moderate-To-Severe Plaque-Type Psoriasis

A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Subjects With Moderate-To-Severe Plaque-Type Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study will test the clinical effectiveness and safety of two orally administered doses of apremilast compared to placebo in Japanese patients with moderate-to-severe plaque-type psoriasis.

Detailed description

This is a phase 2b, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of apremilast 20 mg twice a day (BID), apremilast 30 mg BID, and placebo in Japanese participants with moderate to severe plaque psoriasis.

Conditions

• Psoriasis
• Psoriatic Arthritis
• Psoriasis Arthropatica

Interventions

Type	Name	Description
DRUG	Apremilast	20 mg tablet BID for 68 weeks
DRUG	Apremilast	20 mg tablet BID for 68 weeks
DRUG	Placebo	Placebo tablet BID for 16 weeks

Timeline

• Start date: 2013-07-09
• Primary completion: 2014-11-20
• Completion: 2015-12-15
• First posted: 2013-11-20
• Last updated: 2020-05-07
• Results posted: 2020-03-20

Locations

56 sites across 1 country: Japan