At a glance
ClinicalIndex Comparison Record- ✓Severe hidradenitis suppurativa (Stage II or III) clinically confirmed, defined as recurrent abscesses with ≥4 lesions with sinus tracks and scar formation, unresponsive to prior standard therapies (topical/oral antibiotics, intralesional steroids)
- ✓Age 18 or older
- ✓Able to give informed consent
- ✕Any previous use of TNF-α inhibitors
- ✕Active infection within 30 days of day 0 that is moderate or severe or requires antibiotic treatment
- ✕History of tuberculosis, other mycobacterial disease, or positive PPD (≥5 mm)
- ✕Known history of immunosuppressing disease such as HIV
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Open Label Clinical Trial of Etanercept for the Treatment of Hidradenitis Suppurativa
In Brief
A Phase 2 clinical trial evaluating etanercept for Hidradenitis Suppurativa. Completed, enrolled 15 participants.
Detailed Summary
This study is being done to test a drug called etanercept (Enbrel®). Etanercept has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic moderate to severe plaque psoriasis (PsO), for use in reducing the signs and symptoms of moderately to severely active rheumatoid arthritis (RA) in adults and children, and psoriatic arthritis (PsA) and ankylosing spondylitis (AS) in adults. It is available by prescription for the treatment of PsO, RA, PsA, and AS. Etanercept is approved for injection under the skin at a dose of 50 mg per week in patients with psoriasis. The purpose of this study is to determine whether etanercept is safe and effective for the treatment of hidradenitis. Another purpose of this study is to determine the impact of etanercept treatment of hidradenitis on skin related to quality of life. The skin lesions typically associated with hidradenitis are thought to be partly due to a blockage that occurs in sweat glands, called apocrine ducts, which become inflamed and eventually destroyed. A protein found in the body called tumor necrosis factor alpha, or TNF- α, is a hormone that causes this inflammation or swelling. The study drug, etanercept, blocks the action of TNF- α. By blocking the action of TNF-α, etanercept may provide a reduction in the signs and symptoms of hidradenitis. This study will take place at the University of Pennsylvania and will involve up to 21 participants ages 18 and up. Approximately 21 subjects will participate at the University of Pennsylvania. Each patient will participate in this study for a maximum of 6 months. The study consists of a screening visit, baseline assessment visit (Day 1), a treatment period (Week 2 - Week 14), and a one month follow-up visit (Week 18 visit). The total duration of the study will be approximately 2 years.
Study Details
Timeline
Interventions
etanercept 50 mg/week subcutaneous injection