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

February 14, 2024 updated by: ChemoCentryx

A Randomized , Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Primary efficacy analysis will be at 12 weeks.

Study Type

Interventional

Enrollment (Actual)

435

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Clinical Site
      • Birmingham, Alabama, United States, 35244
        • Clinical Site
      • Mobile, Alabama, United States, 36608
        • Clinical Site
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Clinical Site
      • Scottsdale, Arizona, United States, 85255
        • Clinical Site
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916
        • Clinical Site
      • Rogers, Arkansas, United States, 72758
        • Clinical Site
    • California
      • Fountain Valley, California, United States, 92708
        • Clinical Site
      • Fremont, California, United States, 94538
        • Clinical Site
      • Fullerton, California, United States, 92821
        • Clinical Site
      • Huntington Beach, California, United States, 92647
        • Clinical Site
      • Inglewood, California, United States, 90301
        • Clinical Site
      • Los Angeles, California, United States, 90025
        • Clinical Site
      • Los Angeles, California, United States, 90045
        • Clinical Site
      • Los Angeles, California, United States, 90057
        • Clinical Site
      • Manhattan Beach, California, United States, 90266
        • Clinical Site
      • Newport Beach, California, United States, 92660
        • Clinical Site
      • Northridge, California, United States, 91324
        • Clinical Site
      • Redwood City, California, United States, 94063
        • Clinical Site
      • Thousand Oaks, California, United States, 91320
        • Clinical Site
      • Walnut Creek, California, United States, 94598
        • Clinical Site
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Clinical Site
      • Clearwater, Florida, United States, 33765
        • Clinical Site
      • Hialeah, Florida, United States, 33016
        • Clinical Site
      • Hollywood, Florida, United States, 33021
        • Clinical Site
      • Homestead, Florida, United States, 33030
        • Clinical Site
      • Miami, Florida, United States, 33125
        • Clinical Site
      • Miami, Florida, United States, 33144
        • Clinical Site
      • Miami, Florida, United States, 33173
        • Clinical Site
      • Ocala, Florida, United States, 34470
        • Clinical Site
      • Orlando, Florida, United States, 32819
        • Clinical Site
      • Pembroke Pines, Florida, United States, 33028
        • Clinical Site
      • Tampa, Florida, United States, 33603
        • Clinical Site
      • Tampa, Florida, United States, 33614
        • Clinical Site
      • Tampa, Florida, United States, 33624
        • Clinical Site
      • Weston, Florida, United States, 33327
        • Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Clinical Site
      • Marietta, Georgia, United States, 30060
        • Clinical Site
      • Newnan, Georgia, United States, 30263
        • Clinical Site
      • Sandy Springs, Georgia, United States, 30328
        • Clinical Site
    • Idaho
      • Boise, Idaho, United States, 83713
        • Clinical Site
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Clinical Site
      • Skokie, Illinois, United States, 60640
        • Clinical Site
    • Indiana
      • Crown Point, Indiana, United States, 46307
        • Clinical Site
      • Evansville, Indiana, United States, 47715
        • Clinical Site
      • Indianapolis, Indiana, United States, 46250
        • Clinical Site
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Clinical Site
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Clinical Site
      • New Orleans, Louisiana, United States, 70124
        • Clinical Site
    • Maryland
      • Largo, Maryland, United States, 20774
        • Clinical Site
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • Clinical Site
      • Boston, Massachusetts, United States, 02101
        • Clinical Site
      • Quincy, Massachusetts, United States, 94598
        • Clinical Site
    • Michigan
      • Clarkston, Michigan, United States, 48346
        • Clinical Site
      • Fort Gratiot, Michigan, United States, 48059
        • Clinical Site
      • Saint Joseph, Michigan, United States, 49085
        • Clinical Site
      • Troy, Michigan, United States, 48084
        • Clinical Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Clinical Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Clinical Site
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Clinical Site
    • New Jersey
      • Verona, New Jersey, United States, 07044
        • Clinical Site
    • New York
      • New York, New York, United States, 10012
        • Clinical Site
      • Rochester, New York, United States, 14623
        • Clinical Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • Clinical Site
      • Charlotte, North Carolina, United States, 028277
        • Clinical Site
      • Charlotte, North Carolina, United States, 28209
        • Clinical Site
      • Charlotte, North Carolina, United States, 28277
        • Clinical Site
      • Wilmington, North Carolina, United States, 28401
        • Clinical Site
    • Ohio
      • Athens, Ohio, United States, 45701
        • Clinical Site
      • Bexley, Ohio, United States, 43209
        • Clinical Site
      • Cleveland, Ohio, United States, 44106
        • Clinical Site
      • Marion, Ohio, United States, 43302
        • Clinical Site
      • Mason, Ohio, United States, 45040
        • Clinical Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Clinical Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Clinical Site
    • Pennsylvania
      • Drexel Hill, Pennsylvania, United States, 19026
        • Clinical Site
      • Hershey, Pennsylvania, United States, 17033
        • Clinical Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Clinical Site
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Clinical Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Clinical Site
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Clinical Site
    • Texas
      • Austin, Texas, United States, 78660
        • Clinical Site
      • Austin, Texas, United States, 78745
        • Clinical Site
      • Dallas, Texas, United States, 75231
        • Clinical Site
      • Houston, Texas, United States, 77054
        • Clinical Site
      • Houston, Texas, United States, 77056
        • Clinical Site
      • Houston, Texas, United States, 77084
        • Clinical Site
      • San Antonio, Texas, United States, 78218
        • Clinical Site
      • Sugar Land, Texas, United States, 77027
        • Clinical Site
    • Washington
      • Spokane, Washington, United States, 99202
        • Clinical Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group A
Placebo twice daily (BID) for Period 1 of the study
Other: Placebo
Placebo
Experimental: Group B
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
Drug: Avacopan
Active treatment
Other Names:
  • CCX168
Experimental: Group C
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
Drug: Avacopan
Active treatment
Other Names:
  • CCX168
Experimental: 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.
Drug: Avacopan
Active treatment
Other Names:
  • CCX168
Experimental: 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.
Drug: Avacopan
Active treatment
Other Names:
  • CCX168

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12.
Time Frame: Baseline to 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Total AN Count at Week 12
Time Frame: Baseline to Week 12

The Change from Baseline in total AN (abscess and inflammatory nodule) count at Week 12 using MMRM and OC in the ITT1 population.

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.

MMRM - mixed effects model for repeated measures; OC- observed case
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
Time Frame: Baseline to Week 12

NRS30 = The 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 score. Percentage is based on the number of subjects with a baseline pain score of at least 3 in each treatment group.

Weekly averages of daily pain will be calculated based on subjects' daily diary recording of the worst pain experienced in the previous 24 hours.

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
Baseline to Week 12
Area Under the Curve From Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 Plasma Concentration on Day 1
Time Frame: Day 1

The Area under the curve from Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 plasma concentration on Day 1 in the PK population.

PK- pharmacokinetics
Day 1
Number of Responders With Baseline Hurley Stage II Who Achieved an AN Count of 0, 1, or 2 at Week 12
Time Frame: Baseline and Week 12

The number of responders With Baseline Hurley Stage II Who Achieved an Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12 using the NRI-CMH Test in the ITT1 population. Hurley Stage II disease is defined as having 1 or more widely separated recurrent abscesses with tract formation and scars.

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.
Baseline and Week 12
Change of IHS4 Score Relative to Baseline at Week 12.
Time Frame: Baseline and Week 12

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.

IHS4 score (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + [number of draining tunnels (fistulae/sinuses) multiplied by 4]. A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS.

IHS4- International HS Severity Scoring System
Baseline and Week 12
Change From Baseline in Inflammatory Nodule Count at Week 12
Time Frame: Baseline and Week 12
A reduction in AN signifies improvement. 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.
Baseline and Week 12
Change From Baseline in Abscess Count at Week 12
Time Frame: Baseline and Week 12
A reduction in abscess count signifies improvement. 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.
Baseline and Week 12
Change From Baseline in Draining Fistula Count at Week 12
Time Frame: Baseline and Week 2, Week 4, Week 8 and Week 12
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.
Baseline and Week 2, Week 4, Week 8 and Week 12
Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS
Time Frame: Baseline and Week 2, Week 4, Week 8 and Week 12
Twelve body areas will be evaluated to calculate the Sartorius and modified Sartorius scores: left and right axillae, left and right inframammary areas, intermammary area, left and right buttocks, left and right inguinocrural folds, perianal area, perineal area, and other. The presence of nodules, abscesses, fistulae, scars, and other findings will be recorded. The longest distance between two lesions and whether lesions are separated by normal skin is recorded. A score of 4 indicates the least severe disease, and higher scores indicate increasingly severe disease. There is no upper limit in the score. 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.
Baseline and Week 2, Week 4, Week 8 and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ChemoCentryx

Investigators

  • Study Director: ChemoCentryx Inc, ChemoCentryx Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2018

Primary Completion (Actual)

January 14, 2021

Study Completion (Actual)

March 9, 2021

Study Registration Dates

First Submitted

February 22, 2019

First Submitted That Met QC Criteria

February 22, 2019

First Posted (Actual)

February 25, 2019

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL016_168

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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