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ClinicalTrial.gov Identifier : NCT03706040

A Study to Evaluate Risankizumab in Adult and Adolescent Subjects With Moderate to Severe Atopic Dermatitis

    Status Recruiting
    Related Conditions
    Atopic Dermatitis

Enrollment Details

155 Worldwide Enrollment Goal

Phases: 

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

This is a type II phase trial.

Protocol ID
M16-813

Brief summary

Top

The purpose of this study is to assess the safety and efficacy of risankizumab for the treatment of moderate to severe atopic dermatitis (AD) in adult and adolescent subjects.

Participant Attributes :
  • Male and Female
  • Ages 12 years and more

Canada: 7

0
Calgary, AB
1
London, ON
2
Markham, ON
3
Ottawa, ON
4
Sudbury, ON
5
Toronto, ON
6
St-Jerome, QC
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Study Design

  • 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 (Participant/Investigator)

  • 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

    • Adults who are ≥ 18 years old and, where locally permissible and approved, adolescent subjects who are at least 12 years old.
    • A diagnosis of atopic dermatitis (AD) with onset of symptoms at least 2 years prior to Baseline and subject meets Hanifin and Rajka criteria.
    • Moderate to severe AD at the Baseline Visit.
    • History of inadequate response to previous topical corticosteroid and/or topical calcineurin inhibitor treatments or a medical inability to receive these treatments.
    • Prior exposure to any biologic immunomodulatory agent or Janus kinase (JAK) inhibitor
    • Concurrent treatment with systemic therapy for AD (biologic or non-biologic) or topical and/or phototherapy treatments

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