CompletedPhase 3

BI 655066 Versus Placebo & Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis

577 participantsStarted 2016-03

Plain-language summary

This is a randomized double blind, double dummy, placebo and active comparator controlled, parallel design study that is being performed to assess the safety and efficacy of risankizumab (BI 655066) to support registration for the treatment of moderate to severe chronic plaque psoriasis in adult patients.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Have an involved body surface area (BSA) ≥ 10% and
✓. Have a Psoriasis Area and Severity Index (PASI) score ≥ 12 and
✓. Have a static Physician Global Assessment (sPGA) score of ≥ 3.

Exclusion criteria

✕. non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular),
✕. current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium),
✕. active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to investigator's judgment,

What they're measuring

Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)

Timeframe: Week 16

Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)

Timeframe: Week 16

Trial details

NCT IDNCT02684357

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12

Results submitted2019-05-03

View on ClinicalTrials.gov More Psoriasis trials