Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA)

This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Avacopan, ChemoCentryx, Skin Disease, Inflammatory nodule, Abscess, Sinus formation, Fistula formation Read More

Inclusion Criteria:

• At least 18 years of age
• Clinical diagnosis of HS (Hurley Stage II or III), confirmed by a dermatologist, for at least 6 months prior to Screening
• HS lesions are present in at least 2 distinct anatomic areas
• Inadequate or loss of response to a systemic course of antibiotics typically of at least 90 days
• Must have at least 5 inflammatory nodules or abscesses at screening
• Use adequate birth control for subject and partners of child bearing potential
• Willing and able to give written Informed Consent

Exclusion Criteria:

• Pregnant or breast-feeding
• Any other skin disease that may interfere with the assessment of HS
• Rapidly progressive, expanding HS within 30 days prior to screening
• More than 20 draining fistulae at screening
• Any anti-TNF-α treatment for HS or for other conditions prior to Day 1 visit will be prohibited. Exception: Subjects who were previously treated with an anti-TNF-α drug and discontinued treatment >12 weeks prior to Day 1 visit are allowed for enrollment
• Systemic antibiotics are generally excluded
• Topical antibiotics use within 14 days prior to Day 1 is excluded
• Have started a topical prescription medicine for HS within 14 days prior to screening
• A systemic medicine for HS, including biologics and other systemic therapies
• Have received within 14 days prior to Day 1 visit or is expected to require oral or transdermal opioid analgesics (except for tramadol) for any reason