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

Sponsor
Amgen
Study ID
NCT01988103
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apremilast — DRUG
    20 mg tablet BID for 68 weeks
  • Apremilast — DRUG
    20 mg tablet BID for 68 weeks
  • Placebo — DRUG
    Placebo tablet BID for 16 weeks

Study Details

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.

Key Dates

First listed
Nov 20, 2013
Start date
Jul 9, 2013
Status verified
Apr 2020
Primary completion
Nov 20, 2014
Completion
Dec 15, 2015

Study Design

Enrollment
254 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apremilast 20mg
    Apremilast 20 mg tablets orally twice a day (BID)
  • Experimental: Apremilast 30mg
    Apremilast 30 mg tablets orally BID
  • Placebo Comparator: Placebo
    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

Primary Outcome Measure

Percentage of Participants Who Achieved a 75% Improvement (Response) From Baseline in the Psoriasis Area and Severity Index (PASI-75) at Week 16 [ Time Frame: Baseline to Week 16 ]

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