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

NCT03852472 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CL016_168
• Study Type: interventional
• Target: 435
• Locations: 1 country
• Sites: 91

Brief Summary

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

Conditions

Hidradenitis Suppurativa; Acne Inversa

Keywords

Avacopan; ChemoCentryx; Skin Disease; Inflammatory nodule; Abscess; Sinus formation; Fistula formation

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12.

  The percentage of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 in the ITT1 population using the NRI-CMH Test. A response was defined as a reduction of at least 50 in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count compared with baseline. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1. NRI- non-responder imputation; CMH- Cochran-Mantel-Haenszel. Percentage values have been reported as opposed to proportion values to allow for statistical analyses.

  Baseline to Week 12

Secondary Outcomes (9)

• Change From Baseline in Total AN Count at Week 12

  Baseline to Week 12

• Number of Responders Achieving at Least 30% Reduction and at Least 1 Unit Reduction From Baseline in the Subject's Global Assessment of Skin Pain (NRS30) in Subjects With a Baseline NRS of at Least 3, Evaluated at Week 12

  Baseline to Week 12

• Area Under the Curve From Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 Plasma Concentration on Day 1

  Day 1

• Number of Responders With Baseline Hurley Stage II Who Achieved an AN Count of 0, 1, or 2 at Week 12

  Baseline and Week 12

• Change of IHS4 Score Relative to Baseline at Week 12.

  Baseline and Week 12

Study Arms (5)

Group A

PLACEBO COMPARATOR

Placebo twice daily (BID) for Period 1 of the study

Other: Placebo

Group B

EXPERIMENTAL

Avacopan 10 mg twice daily (BID) for Period 1+2 of the study

Drug: Avacopan

Group C

EXPERIMENTAL

Avacopan 30 mg twice daily (BID) for Period 1+2 of the study

Drug: Avacopan

Placebo to Avacopan 10 mg

EXPERIMENTAL

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.

Drug: Avacopan

Placebo to Avacopan 30 mg

EXPERIMENTAL

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.

Drug: Avacopan

Interventions

Avacopan DRUG

Active treatment

Also known as: CCX168

Group B; Group C; Placebo to Avacopan 10 mg; Placebo to Avacopan 30 mg

Placebo OTHER

Placebo

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Amgen: lead

Study Sites (91)

Clinical Site

Birmingham, Alabama, 35233, United States

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Birmingham, Alabama, 35244, United States

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Mobile, Alabama, 36608, United States

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Phoenix, Arizona, 85006, United States

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Scottsdale, Arizona, 85255, United States

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Fort Smith, Arkansas, 72916, United States

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Rogers, Arkansas, 72758, United States

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Fountain Valley, California, 92708, United States

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Fremont, California, 94538, United States

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Fullerton, California, 92821, United States

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Huntington Beach, California, 92647, United States

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Inglewood, California, 90301, United States

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Los Angeles, California, 90025, United States

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Los Angeles, California, 90045, United States

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Los Angeles, California, 90057, United States

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Manhattan Beach, California, 90266, United States

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Newport Beach, California, 92660, United States

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Northridge, California, 91324, United States

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Redwood City, California, 94063, United States

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Thousand Oaks, California, 91320, United States

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Walnut Creek, California, 94598, United States

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Boca Raton, Florida, 33486, United States

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Clearwater, Florida, 33765, United States

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Hialeah, Florida, 33016, United States

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Hollywood, Florida, 33021, United States

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Homestead, Florida, 33030, United States

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Miami, Florida, 33125, United States

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Miami, Florida, 33144, United States

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Miami, Florida, 33173, United States

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Ocala, Florida, 34470, United States

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Orlando, Florida, 32819, United States

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Pembroke Pines, Florida, 33028, United States

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Tampa, Florida, 33603, United States

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Tampa, Florida, 33614, United States

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Tampa, Florida, 33624, United States

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Weston, Florida, 33327, United States

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Atlanta, Georgia, 30322, United States

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Marietta, Georgia, 30060, United States

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Newnan, Georgia, 30263, United States

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Sandy Springs, Georgia, 30328, United States

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Boise, Idaho, 83713, United States

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Skokie, Illinois, 60077, United States

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Skokie, Illinois, 60640, United States

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Crown Point, Indiana, 46307, United States

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Evansville, Indiana, 47715, United States

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Indianapolis, Indiana, 46250, United States

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Louisville, Kentucky, 40217, United States

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Metairie, Louisiana, 70006, United States

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New Orleans, Louisiana, 70124, United States

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Largo, Maryland, 20774, United States

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Beverly, Massachusetts, 01915, United States

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Boston, Massachusetts, 02101, United States

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Quincy, Massachusetts, 94598, United States

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Clarkston, Michigan, 48346, United States

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Fort Gratiot, Michigan, 48059, United States

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Saint Joseph, Michigan, 49085, United States

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Troy, Michigan, 48084, United States

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Minneapolis, Minnesota, 55455, United States

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St Louis, Missouri, 63110, United States

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Omaha, Nebraska, 68144, United States

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Verona, New Jersey, 07044, United States

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New York, New York, 10012, United States

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Rochester, New York, 14623, United States

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Chapel Hill, North Carolina, 27516, United States

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Charlotte, North Carolina, 028277, United States

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Charlotte, North Carolina, 28209, United States

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Charlotte, North Carolina, 28277, United States

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Wilmington, North Carolina, 28401, United States

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Athens, Ohio, 45701, United States

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Bexley, Ohio, 43209, United States

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Cleveland, Ohio, 44106, United States

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Marion, Ohio, 43302, United States

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Mason, Ohio, 45040, United States

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Norman, Oklahoma, 73071, United States

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Portland, Oregon, 97210, United States

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Drexel Hill, Pennsylvania, 19026, United States

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Hershey, Pennsylvania, 17033, United States

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Philadelphia, Pennsylvania, 19104, United States

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Warwick, Rhode Island, 02886, United States

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Charleston, South Carolina, 29407, United States

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Nashville, Tennessee, 37215, United States

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Austin, Texas, 78660, United States

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Austin, Texas, 78745, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77054, United States

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Houston, Texas, 77056, United States

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Houston, Texas, 77084, United States

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San Antonio, Texas, 78218, United States

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Sugar Land, Texas, 77027, United States

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Spokane, Washington, 99202, United States

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Morgantown, West Virginia, 26505, United States

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MeSH Terms

Conditions

Hidradenitis Suppurativa; Skin Diseases; Abscess

Interventions

avacopan

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Chemocentryx

medinfo@amgen.com

650-210-2900

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: February 25, 2019
• Study Start: December 21, 2018
• Primary Completion: January 14, 2021
• Study Completion: March 9, 2021
• Last Updated: March 17, 2025
• Results First Posted: March 15, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2 ) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (91)