A Study of Ustekinumab (STELARA®) in Adult Japanese Participants With Severe Atopic Dermatitis

Sponsor
Janssen Pharmaceutical K.K.
Study ID
NCT01945086
Phase
PHASE2
Status
Completed

Conditions

  • Dermatitis, Atopic

Eligibility Criteria

Sex
ALL
Age
20 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    Participants will receive subcutaneous (SC) injections of either ustekinumab 45 mg or ustekinumab 90 mg at Week 0 and Week 4.
  • Placebo — DRUG
    Participants will receive SC injections of placebo at Week 0 and Week 4.
  • Concomitant topical medications for atopic dermatitis — OTHER
    Concomitant topical medications (as defined in the protocol) can be used from 4 weeks prior to randomization and throughout the study. However, the dosage cannot be increased and new medications cannot be added until after Week 12.

Study Details

The purpose of this study is to assess the safety and effectiveness of 2 doses of ustekinumab compared with placebo (inactive medication) in adult Japanese participants with severe atopic dermatitis.

Key Dates

First listed
Sep 18, 2013
Start date
Sep 30, 2013
Status verified
Feb 2016
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

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

Arms

  • Experimental: Ustekinumab 45 mg
  • Experimental: Ustekinumab 90 mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

Percent Change in Eczema Area Severity Index (EASI) Total Score From Baseline at Week 12 [ Time Frame: Baseline and Week 12 ]

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