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

Sponsor
ChemoCentryx (Industry)
Overall Status
Completed
CT.gov ID
NCT03852472
Collaborator
(none)
398
Enrollment
91
Locations
3
Arms
26.3
Actual Duration (Months)
4.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
398 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 28, 2018
Actual Primary Completion Date :
Jul 30, 2020
Actual Study Completion Date :
Mar 9, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Group A

Placebo b.i.d

Other: Placebo
Placebo
Active Comparator: Group B

Avacopan 10 mg b.i.d

Drug: Avacopan
Active treatment
Other Names:
  • CCX168

    		•
    Active Comparator: Group C

    Avacopan 30 mg b.i.d

    Drug: Avacopan
    Active treatment
    Other Names:
  • CCX168

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Primary efficacy endpoint assessed by the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12. [12 weeks]

      The proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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
    5 Clinical Site Scottsdale Arizona United States 85255
    6 Clinical Site Fort Smith Arkansas United States 72916
    7 Clinical Site Rogers Arkansas United States 72758
    8 Clinical Site Fountain Valley California United States 92708
    9 Clinical Site Fremont California United States 94538
    10 Clinical Site Fullerton California United States 92821
    11 Clinical Site Huntington Beach California United States 92647
    12 Clinical Site Inglewood California United States 90301
    13 Clinical Site Los Angeles California United States 90025
    14 Clinical Site Los Angeles California United States 90045
    15 Clinical Site Los Angeles California United States 90057
    16 Clinical Site Manhattan Beach California United States 90266
    17 Clinical Site Newport Beach California United States 92660
    18 Clinical Site Northridge California United States 91324
    19 Clinical Site Redwood City California United States 94063
    20 Clinical Site Thousand Oaks California United States 91320
    21 Clinical Site Walnut Creek California United States 94598
    22 Clinical Site Boca Raton Florida United States 33486
    23 Clinical Site Clearwater Florida United States 33765
    24 Clinical Site Hialeah Florida United States 33016
    25 Clinical Site Hollywood Florida United States 33021
    26 Clinical Site Homestead Florida United States 33030
    27 Clinical Site Miami Florida United States 33125
    28 Clinical Site Miami Florida United States 33144
    29 Clinical Site Miami Florida United States 33173
    30 Clinical Site Ocala Florida United States 34470
    31 Clinical Site Orlando Florida United States 32819
    32 Clinical Site Pembroke Pines Florida United States 33028
    33 Clinical Site Tampa Florida United States 33603
    34 Clinical Site Tampa Florida United States 33614
    35 Clinical Site Tampa Florida United States 33624
    36 Clinical Site Weston Florida United States 33327
    37 Clinical Site Atlanta Georgia United States 30322
    38 Clinical Site Marietta Georgia United States 30060
    39 Clinical Site Newnan Georgia United States 30263
    40 Clinical Site Sandy Springs Georgia United States 30328
    41 Clinical Site Boise Idaho United States 83713
    42 Clinical Site Skokie Illinois United States 60077
    43 Clinical Site Skokie Illinois United States 60640
    44 Clinical Site Crown Point Indiana United States 46307
    45 Clinical Site Evansville Indiana United States 47715
    46 Clinical Site Indianapolis Indiana United States 46250
    47 Clinical Site Louisville Kentucky United States 40217
    48 Clinical Site Metairie Louisiana United States 70006
    49 Clinical Site New Orleans Louisiana United States 70124
    50 Clinical Site Largo Maryland United States 20774
    51 Clinical Site Beverly Massachusetts United States 01915
    52 Clinical Site Boston Massachusetts United States 02101
    53 Clinical Site Quincy Massachusetts United States 94598
    54 Clinical Site Clarkston Michigan United States 48346
    55 Clinical Site Fort Gratiot Michigan United States 48059
    56 Clinical Site Saint Joseph Michigan United States 49085
    57 Clinical Site Troy Michigan United States 48084
    58 Clinical Site Minneapolis Minnesota United States 55455
    59 Clinical Site Saint Louis Missouri United States 63110
    60 Clinical Site Omaha Nebraska United States 68144
    61 Clinical Site Verona New Jersey United States 07044
    62 Clinical Site New York New York United States 10012
    63 Clinical Site Rochester New York United States 14623
    64 Clinical Site Chapel Hill North Carolina United States 27516
    65 Clinical Site Charlotte North Carolina United States 028277
    66 Clinical Site Charlotte North Carolina United States 28209
    67 Clinical Site Charlotte North Carolina United States 28277
    68 Clinical Site Wilmington North Carolina United States 28401
    69 Clinical Site Athens Ohio United States 45701
    70 Clinical Site Bexley Ohio United States 43209
    71 Clinical Site Cleveland Ohio United States 44106
    72 Clinical Site Marion Ohio United States 43302
    73 Clinical Site Mason Ohio United States 45040
    74 Clinical Site Norman Oklahoma United States 73071
    75 Clinical Site Portland Oregon United States 97210
    76 Clinical Site Drexel Hill Pennsylvania United States 19026
    77 Clinical Site Hershey Pennsylvania United States 17033
    78 Clinical Site Philadelphia Pennsylvania United States 19104
    79 Clinical Site Warwick Rhode Island United States 02886
    80 Clinical Site Charleston South Carolina United States 29407
    81 Clinical Site Nashville Tennessee United States 37215
    82 Clinical Site Austin Texas United States 78660
    83 Clinical Site Austin Texas United States 78745
    84 Clinical Site Dallas Texas United States 75231
    85 Clinical Site Houston Texas United States 77054
    86 Clinical Site Houston Texas United States 77056
    87 Clinical Site Houston Texas United States 77084
    88 Clinical Site San Antonio Texas United States 78218
    89 Clinical Site Sugar Land Texas United States 77027
    90 Clinical Site Spokane Washington United States 99202
    91 Clinical Site Morgantown West Virginia United States 26505

    Sponsors and Collaborators

    • ChemoCentryx

    Investigators

    • Study Director: ChemoCentryx Inc, ChemoCentryx Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ChemoCentryx
    ClinicalTrials.gov Identifier:
    NCT03852472
    Other Study ID Numbers:
    • CL016_168
    First Posted:
    Feb 25, 2019
    Last Update Posted:
    Feb 25, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by ChemoCentryx
    Avacopan
    ChemoCentryx
    Skin Disease
    Inflammatory nodule
    Abscess
    Sinus formation
    Fistula formation
    Additional relevant MeSH terms:
    Hidradenitis Suppurativa
    Hidradenitis

    Study Results

    No Results Posted as of Feb 25, 2022