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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa, Acne Inversa

In brief

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

Key facts

Study ID

NCT03852472

Run by

Amgen

People needed

435

Starts

2018-12-21

Expected to finish

2021-03-09

Last updated by the study team

2025-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Site — Birmingham, Alabama, United States
• Clinical Site — Mobile, Alabama, United States
• Clinical Site — Phoenix, Arizona, United States
• Clinical Site — Scottsdale, Arizona, United States
• Clinical Site — Fort Smith, Arkansas, United States
• Clinical Site — Rogers, Arkansas, United States
• Clinical Site — Fountain Valley, California, United States
• Clinical Site — Fremont, California, United States
• Clinical Site — Fullerton, California, United States
• Clinical Site — Huntington Beach, California, United States
• Clinical Site — Inglewood, California, United States
• Clinical Site — Los Angeles, California, United States
• Clinical Site — Los Angeles, California, United States
• Clinical Site — Los Angeles, California, United States
• Clinical Site — Manhattan Beach, California, United States
• Clinical Site — Newport Beach, California, United States
• Clinical Site — Northridge, California, United States
• Clinical Site — Redwood City, California, United States
• Clinical Site — Thousand Oaks, California, United States
• Clinical Site — Walnut Creek, California, United States
• Clinical Site — Boca Raton, Florida, United States
• Clinical Site — Clearwater, Florida, United States
• Clinical Site — Hialeah, Florida, United States
• Clinical Site — Hollywood, Florida, United States
• Clinical Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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