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

• Status: Completed
• Trial end date: 2021-08-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Antibodies, Monoclonal

Criteria

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.