Status:
COMPLETED
Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA)
Lead Sponsor:
Amgen
Conditions:
Hidradenitis Suppurativa
Acne Inversa
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Phase 2 study of Avacopan in Subjects with Moderate to Severe Hidradenitis Suppurativa
Detailed Description
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 study in subjects with moderate to severe Hidradenitis Suppurativa. The study is multicenter and will consist of three subject ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2021
Estimated Enrollment :
435 Patients enrolled
Trial Details
Trial ID
NCT03852472
Start Date
December 21 2018
End Date
March 9 2021
Last Update
March 17 2025
Active Locations (91)
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1
Clinical Site
Birmingham, Alabama, United States, 35233
2
Clinical Site
Birmingham, Alabama, United States, 35244
3
Clinical Site
Mobile, Alabama, United States, 36608
4
Clinical Site
Phoenix, Arizona, United States, 85006