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

Phase 2

Completed

• Conditions: Hidradenitis Suppurativa

• Registration Number: JPRN-jRCT2080224861
• Lead Sponsor: AbbVie G.K.

Brief Summary

Risankizumab, administered as 180 mg SC or 360 mg SC, failed to meet the primary endpoint of the proportion of subjects achieving HiSCR at Week 16. The observed safety profile for risankizumab in this study was consistent with the safety profile observed in other studies of risankizumab.No new safety signals were identified.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-09
• Study Completion: 2021-08-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 243

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

• Study Type: Interventional
• Study Design: Not specified