Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA)
NCT ID: NCT03852472
Last Updated: 2025-03-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
435 participants
INTERVENTIONAL
2018-12-21
2021-03-09
Brief Summary
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Detailed Description
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The study is multicenter and will consist of three subject groups. Subjects will be randomized 1:1:1 to a treatment of 10mg avacopan twice daily, 30 mg avacopan twice daily or placebo twice daily for 12 weeks.
Following the 12 weeks double-blind treatment period, subjects on placebo will be re-randomized 1:1 to receive 10 mg or 30 mg avacopan twice daily for additional 24 weeks. Subjects treated with avacopan will continue to receive the same dose (either 10 mg or 30 mg twice daily) for additional 24 weeks.
Subjects will be on study treatment for 36 weeks and will be followed for 44 weeks for assessment of safety and efficacy.
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
Primary efficacy analysis will be at 12 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A
Placebo twice daily (BID) for Period 1 of the study
Placebo
Placebo
Group B
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
Avacopan
Active treatment
Group C
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
Avacopan
Active treatment
Placebo to Avacopan 10 mg
Treatment period 2, subjects randomized to placebo during period 1 were rerandomized 1:1 to receive 10 mg or 30 mg avacopan BID in period 2.
Avacopan
Active treatment
Placebo to Avacopan 30 mg
Treatment period 2, subjects randomized to placebo during period 1 were rerandomized 1:1 to receive 10 mg or 30 mg avacopan BID in period 2.
Avacopan
Active treatment
Interventions
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Avacopan
Active treatment
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Clinical Site
Birmingham, Alabama, United States
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
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Fremont, California, United States
Clinical Site
Fullerton, California, United States
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Huntington Beach, California, United States
Clinical Site
Inglewood, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Manhattan Beach, California, United States
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Newport Beach, California, United States
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Northridge, California, United States
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Redwood City, California, United States
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Thousand Oaks, California, United States
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Walnut Creek, California, United States
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Boca Raton, Florida, United States
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Clearwater, Florida, United States
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Hialeah, Florida, United States
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Hollywood, Florida, United States
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Homestead, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Weston, Florida, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Newnan, Georgia, United States
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Sandy Springs, Georgia, United States
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Boise, Idaho, United States
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Skokie, Illinois, United States
Clinical Site
Skokie, Illinois, United States
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Crown Point, Indiana, United States
Clinical Site
Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Louisville, Kentucky, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Largo, Maryland, United States
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Beverly, Massachusetts, United States
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Boston, Massachusetts, United States
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Quincy, Massachusetts, United States
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Clarkston, Michigan, United States
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Fort Gratiot, Michigan, United States
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Saint Joseph, Michigan, United States
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Troy, Michigan, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Verona, New Jersey, United States
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New York, New York, United States
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Rochester, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
Clinical Site
Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
Clinical Site
Wilmington, North Carolina, United States
Clinical Site
Athens, Ohio, United States
Clinical Site
Bexley, Ohio, United States
Clinical Site
Cleveland, Ohio, United States
Clinical Site
Marion, Ohio, United States
Clinical Site
Mason, Ohio, United States
Clinical Site
Norman, Oklahoma, United States
Clinical Site
Portland, Oregon, United States
Clinical Site
Drexel Hill, Pennsylvania, United States
Clinical Site
Hershey, Pennsylvania, United States
Clinical Site
Philadelphia, Pennsylvania, United States
Clinical Site
Warwick, Rhode Island, United States
Clinical Site
Charleston, South Carolina, United States
Clinical Site
Nashville, Tennessee, United States
Clinical Site
Austin, Texas, United States
Clinical Site
Austin, Texas, United States
Clinical Site
Dallas, Texas, United States
Clinical Site
Houston, Texas, United States
Clinical Site
Houston, Texas, United States
Clinical Site
Houston, Texas, United States
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San Antonio, Texas, United States
Clinical Site
Sugar Land, Texas, United States
Clinical Site
Spokane, Washington, United States
Clinical Site
Morgantown, West Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CL016_168
Identifier Type: -
Identifier Source: org_study_id
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