Conditions: Psoriasis Psoriatic Arthritis Psoriasis Arthropatica
Keywords: Psoriasis; Psoriatic Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 254
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Apremilast 20 mg tablets orally twice a day (BID) arm 2: Apremilast 30 mg tablets orally BID arm 3: Identically-appearing placebo tablets BID for 16 weeks followed by participants being re-randomized in a blinded fasion to apremilast 20 mg or 30mg tablets BID for 52 weeks

Interventions: intervention 1: Apremilast intervention 2: Apremilast intervention 3: Placebo
Intervention descriptions: intervention 1: 20 mg tablet BID for 68 weeks intervention 2: 20 mg tablet BID for 68 weeks intervention 3: Placebo tablet BID for 16 weeks

Protocol document: