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

• Status: Active, not recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Phase 2 study of Avacopan in Subjects with Moderate to Severe Hidradenitis Suppurativa

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

Details

• Lead Sponsor: ChemoCentryx

Criteria

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