Study of an Investigational Drug to Reduce HS Inflammation

Study PI: Sarah Whitley, MD, PhD
Sponsors: AbbVie

A Phase 3, randomized, placebo-controlled, double-blind study to evaluate efficacy and safety of upadacitinib in adult and adolescent subjects with moderate to severe hidradenitis suppurativa who have failed anti-TNF therapy’.

Overview

Participants in this study will either get injected with the investigational drug or a placebo (looks like the drug but contains no medicine) approximately every 2 weeks over 12 weeks. Over the 1 year study period there will be up to 12 clinic visits.

Eligibility

Inclusion Criteria

• ≥ 12 years old
• Moderate-severe active HS
• Previous use of ≥ 1 TNF inhibitor for HS for at least 12 weeks and/or 1 approved non-anti-TNF biologic therapy for HS for at least 16 weeks characterized by inadequate response or intolerance.

Exclusion Criteria

• Pregnant or breastfeeding
• Treatment with immunomodulatory biologic therapy for any indication within the prior 8-16 weeks
• Active infection.