Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Risankizumab: Dose A
Participants randomized to receive risankizumab dose A in treatment period A and placebo followed by risankizumab dose B in treatment period B
  • Drug: Risankizumab
    Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
    Other names:
    • ABBV-066
  • Drug: Placebo for risankizumab
    Placebo for risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
Experimental
Risankizumab: Dose B
Participants randomized to receive risankizumab dose B in treatment period A and placebo followed by risankizumab dose B in treatment period B
  • Drug: Risankizumab
    Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
    Other names:
    • ABBV-066
  • Drug: Placebo for risankizumab
    Placebo for risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
Placebo Comparator
Placebo
Participants randomized to receive Placebo in treatment period A and risankizumab dose B in treatment period B
  • Drug: Risankizumab
    Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
    Other names:
    • ABBV-066
  • Drug: Placebo for risankizumab
    Placebo for risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)

Recruiting Locations

Montefiore Medical Center /ID# 211800
Bronx, New York 10461

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
847.283.8955
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.