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ClinicalTrial.gov Identifier : NCT03926169

A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

    Status Recruiting
    Related Conditions
    Hidradenitis Suppurativa

Enrollment Details

190 Worldwide Enrollment Goal

Phases: 

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

This is a type II phase trial.

Protocol ID
M16-833

Brief summary

Top

This study is to evaluate the safety and efficacy of 2 dose levels of risankizumab in adult participants with moderate to severe Hidradenitis Suppurativa (HS). This study includes two treatment periods. In Period A, participants are randomized to receive either risankizumab dose A, dose B, or placebo. In Period B, participants who received risankizumab dose A or placebo during Period A, will receive risankizumab dose B. Participants who received risankizumab dose B in Period A will remain on that dose in Period B.

Participant Attributes :
  • Male and Female
  • Ages 18 years and older (Adult, Older Adult)

Canada: 5

0
Winnipeg, MB
1
Fredericton, NB
2
Hamilton, ON
3
Waterloo, ON
4
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

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

    Quadruple (Participant, Care Provider, 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

    • Participant with moderate to severe Hidradenitis Suppurativa (HS) for at least one year prior to Baseline visit.
    • HS lesions present in at least two distinct anatomical areas.
    • Draining fistula count of <=20 at Baseline visit.
    • Total abscesses and nodule count (AN count) of >= 5 at Baseline visit.
    • Participants are required to use a daily antiseptic wash on their HS lesions.
    • Participant must have a history of inadequate response or intolerance to an adequate trial of oral antibiotics for treatment of HS.
    • Participant has a history of active skin disease other than HS that could interfere with the assessment of HS.
    • Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immuno deficiency virus (HIV) infection.
    • Participant has prior exposure to anti-interleukin-1 (anti-IL-1) treatment within 3 months or 5 half-lives, whichever is longer, prior to baseline.
    • Participant has received prescription topical therapies (including topical antibiotics) within 14 days prior to the Baseline visit.
    • Participant has received systemic non-biologic therapies that can also be used to treat HS within 4 weeks prior to the Baseline visit.
    • Participant has received any systemic (including oral) antibiotic treatment within 4 weeks prior to the Baseline visit.

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