A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy

Sponsor
AbbVie
Study ID
NCT03255382
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Fumaderm — DRUG
    Fumaderm tablet administered orally
  • risankizumab — DRUG
    Risankizumab administered by subcutaneous (SC) injection

Study Details

The purpose of this study is to compare the efficacy and safety of subcutaneous (SC) risankizumab and oral FUMADERM provided as study medication in participants with moderate to severe plaque psoriasis who are naïve to and candidates for systemic therapy.

Key Dates

Start date
Aug 22, 2017
Status verified
Aug 2019
Primary completion
Jul 6, 2018
Completion
Jul 6, 2018

Study Design

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

Arms

  • Experimental: Risankizumab
    Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
  • Active Comparator: Fumaderm
    Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2 and then up to 240 mg, 3 times daily from Week 3 to Week 24 if 90% Improvement in Psoriasis Area and Severity Index (PASI90) is not achieved and if tolerability allows.

Primary Outcome Measure

Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24 [ Time Frame: Week 24 ]

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