A Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

Sponsor
AbbVie
Study ID
NCT03022045
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • risankizumab — DRUG
    risankizumab administered by subcutaneous injection

Study Details

The purpose of this study is to investigate the safety and efficacy of two different dose regimens of risankizumab for Japanese subjects with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).

Key Dates

Start date
Jan 26, 2017
Status verified
Nov 2021
Primary completion
Sep 17, 2017
Completion
Nov 19, 2020

Study Design

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

Arms

  • Experimental: Risankizumab 75 mg
    Participants randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
  • Experimental: Risankizumab 150 mg
    Participants randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.

Primary Outcome Measure

Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16 [ Time Frame: Week 16 ]

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