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UltIMMa-1

BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis 

    Status Active, not recruiting
    Related Conditions
    Psoriasis

Enrollment Details

500 Worldwide Enrollment Goal

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type III phase trial.

Protocol ID
M16-008 (BI study 1311.3)

Brief summary

Top

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 BI 655066/ABBV-066 (risankizumab) to support registration for the treatment of moderate to severe chronic plaque psoriasis in adult patients. 

Participant Attributes :
  • Male and Female
  • Ages 18 Years and older
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Study Design

  • The method used to assign participants to an arm of a clinical trial, for example Randomized (assigned by chance) versus Non-randomized.
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    Allocation

    Randomized

  • A target outcome that the study’s protocol aims to evaluate - things like: the occurrence of a disease, a symptom, sign, or lab abnormality, among others.
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    Endpoint Classification

    Safety/Efficacy Study

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
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    Intervention Model

    Parallel Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
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    Masking

    Double Blind (Subject, Investigator, Outcomes Assessor)

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
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    Purpose

    Treatment

    • Male or female patients with age >= 18 years at screening.
    • Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug.
    • Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomisation):
    • 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.
    • Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator.
    • Must be a candidate for treatment with Stelara® (ustekinumab) according to local label.
    • Patients with:

      a.non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)

      b.current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)

      c.active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to investigator's judgment

    • Previous exposure to BI 655066.
    • Previous exposure to ustekinumab (Stelara®).