Evaluation of Safety and Efficacy of Avacopan in Subjects... | NCT03852472 | Trialant
NCT03852472
Sponsor
Amgen
Status
Completed
Last Update Posted
Mar 17, 2025Actual
Enrollment
435Actual
Phase
Phase 2
Conditions
Hidradenitis Suppurativa
Acne Inversa
Interventions
Avacopan
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03852472
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CL016_168
Secondary IDs
Not provided
Brief Title
Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA)
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
Acronym
Not provided
Organization
AmgenINDUSTRY
Status Module
Record Verification Date
Feb 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 21, 2018Actual
Primary Completion Date
Jan 14, 2021Actual
Completion Date
Mar 9, 2021Actual
First Submitted Date
Feb 22, 2019
First Submission Date that Met QC Criteria
Feb 22, 2019
First Posted Date
Feb 25, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Aug 9, 2023
Results First Submitted that Met QC Criteria
Feb 14, 2024
Results First Posted Date
Mar 15, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 25, 2025
Last Update Posted Date
Mar 17, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AmgenINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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 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 Module
Conditions
Hidradenitis Suppurativa
Acne Inversa
Keywords
Avacopan
ChemoCentryx
Skin Disease
Inflammatory nodule
Abscess
Sinus formation
Fistula formation
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
435Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
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
Name
Type
Description
Arm Group Labels
Other Names
Avacopan
Drug
Active treatment
Group B
Group C
Placebo to Avacopan 10 mg
Placebo to Avacopan 30 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Measure
Description
Time Frame
Change From Baseline in Total AN Count at 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
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
MD
Amgen
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Clinical Site
Birmingham
Alabama
35233
United States
Clinical Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
Periods
Title
Milestones
Reasons Not Completed
Period 1 - 12 Weeks
Type
Comment
Milestone Data
STARTED
The Intent-to-Treat Population in period 1 (ITT1) was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1 and excluded Site 138 subjects (please see additional milestone below for exact figures)
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jul 31, 2019
Aug 9, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
CCX168
Placebo
Other
Placebo
Group A
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
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
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
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.
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
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
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
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
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
Birmingham
Alabama
35244
United States
Clinical Site
Mobile
Alabama
36608
United States
Clinical Site
Phoenix
Arizona
85006
United States
Clinical Site
Scottsdale
Arizona
85255
United States
Clinical Site
Fort Smith
Arkansas
72916
United States
Clinical Site
Rogers
Arkansas
72758
United States
Clinical Site
Fountain Valley
California
92708
United States
Clinical Site
Fremont
California
94538
United States
Clinical Site
Fullerton
California
92821
United States
Clinical Site
Huntington Beach
California
92647
United States
Clinical Site
Inglewood
California
90301
United States
Clinical Site
Los Angeles
California
90025
United States
Clinical Site
Los Angeles
California
90045
United States
Clinical Site
Los Angeles
California
90057
United States
Clinical Site
Manhattan Beach
California
90266
United States
Clinical Site
Newport Beach
California
92660
United States
Clinical Site
Northridge
California
91324
United States
Clinical Site
Redwood City
California
94063
United States
Clinical Site
Thousand Oaks
California
91320
United States
Clinical Site
Walnut Creek
California
94598
United States
Clinical Site
Boca Raton
Florida
33486
United States
Clinical Site
Clearwater
Florida
33765
United States
Clinical Site
Hialeah
Florida
33016
United States
Clinical Site
Hollywood
Florida
33021
United States
Clinical Site
Homestead
Florida
33030
United States
Clinical Site
Miami
Florida
33125
United States
Clinical Site
Miami
Florida
33144
United States
Clinical Site
Miami
Florida
33173
United States
Clinical Site
Ocala
Florida
34470
United States
Clinical Site
Orlando
Florida
32819
United States
Clinical Site
Pembroke Pines
Florida
33028
United States
Clinical Site
Tampa
Florida
33603
United States
Clinical Site
Tampa
Florida
33614
United States
Clinical Site
Tampa
Florida
33624
United States
Clinical Site
Weston
Florida
33327
United States
Clinical Site
Atlanta
Georgia
30322
United States
Clinical Site
Marietta
Georgia
30060
United States
Clinical Site
Newnan
Georgia
30263
United States
Clinical Site
Sandy Springs
Georgia
30328
United States
Clinical Site
Boise
Idaho
83713
United States
Clinical Site
Skokie
Illinois
60077
United States
Clinical Site
Skokie
Illinois
60640
United States
Clinical Site
Crown Point
Indiana
46307
United States
Clinical Site
Evansville
Indiana
47715
United States
Clinical Site
Indianapolis
Indiana
46250
United States
Clinical Site
Louisville
Kentucky
40217
United States
Clinical Site
Metairie
Louisiana
70006
United States
Clinical Site
New Orleans
Louisiana
70124
United States
Clinical Site
Largo
Maryland
20774
United States
Clinical Site
Beverly
Massachusetts
01915
United States
Clinical Site
Boston
Massachusetts
02101
United States
Clinical Site
Quincy
Massachusetts
94598
United States
Clinical Site
Clarkston
Michigan
48346
United States
Clinical Site
Fort Gratiot
Michigan
48059
United States
Clinical Site
Saint Joseph
Michigan
49085
United States
Clinical Site
Troy
Michigan
48084
United States
Clinical Site
Minneapolis
Minnesota
55455
United States
Clinical Site
St Louis
Missouri
63110
United States
Clinical Site
Omaha
Nebraska
68144
United States
Clinical Site
Verona
New Jersey
07044
United States
Clinical Site
New York
New York
10012
United States
Clinical Site
Rochester
New York
14623
United States
Clinical Site
Chapel Hill
North Carolina
27516
United States
Clinical Site
Charlotte
North Carolina
028277
United States
Clinical Site
Charlotte
North Carolina
28209
United States
Clinical Site
Charlotte
North Carolina
28277
United States
Clinical Site
Wilmington
North Carolina
28401
United States
Clinical Site
Athens
Ohio
45701
United States
Clinical Site
Bexley
Ohio
43209
United States
Clinical Site
Cleveland
Ohio
44106
United States
Clinical Site
Marion
Ohio
43302
United States
Clinical Site
Mason
Ohio
45040
United States
Clinical Site
Norman
Oklahoma
73071
United States
Clinical Site
Portland
Oregon
97210
United States
Clinical Site
Drexel Hill
Pennsylvania
19026
United States
Clinical Site
Hershey
Pennsylvania
17033
United States
Clinical Site
Philadelphia
Pennsylvania
19104
United States
Clinical Site
Warwick
Rhode Island
02886
United States
Clinical Site
Charleston
South Carolina
29407
United States
Clinical Site
Nashville
Tennessee
37215
United States
Clinical Site
Austin
Texas
78660
United States
Clinical Site
Austin
Texas
78745
United States
Clinical Site
Dallas
Texas
75231
United States
Clinical Site
Houston
Texas
77054
United States
Clinical Site
Houston
Texas
77056
United States
Clinical Site
Houston
Texas
77084
United States
Clinical Site
San Antonio
Texas
78218
United States
Clinical Site
Sugar Land
Texas
77027
United States
Clinical Site
Spokane
Washington
99202
United States
Clinical Site
Morgantown
West Virginia
26505
United States
FG002
Group C
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
FG003
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.
FG004
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.
FG000130 subjects
FG001134 subjects
FG002134 subjects
FG0030 subjectsArm is an extension of Group A from Period 1
FG0040 subjectsArm is an extension of Group A from Period 1
Excluded Site 138 Subjects From ITT1
Subjects from Site 138 were excluded from the analysis due to potential misconduct and noncompliance at this site.
FG00013 subjects
FG00111 subjects
FG00213 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG000109 subjects
FG001108 subjects
FG002109 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG00021 subjects
FG00126 subjects
FG00225 subjects
FG0030 subjects
FG0040 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0008 subjects
FG00110 subjects
FG0027 subjects
FG0030 subjects
FG0040 subjects
Subject noncompliance with dosing or diary completion
FG0000 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
Lost to Follow-up
FG0005 subjects
FG0015 subjects
FG0027 subjects
FG0030 subjects
FG004
Noncompliance with the protocol
FG0002 subjects
FG0010 subjects
FG0024 subjects
FG0030 subjects
FG004
At the discretion of the investigator or sponsor for any reason
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
Adverse Event
FG0004 subjects
FG0016 subjects
FG0024 subjects
FG0030 subjects
FG004
Reason not stated
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Period 2 - Week 44
Type
Comment
Milestone Data
STARTED
The Intent-to-Treat Population in period 2 (ITT2) was defined as all subjects who received at least 1 dose of investigational product during period 2 and excluded Site 138 subjects (please see additional milestone below for exact figures)
FG0000 subjectsIn Period 2 this arm becomes Placebo to Avacopan 10mg and Placebo to Avacopan 30mg arms.
FG001108 subjects
FG002108 subjectsAs per ITT2 population, 108 participants were enrolled from period 1.
FG00356 subjectsAs per ITT2 population, 56 participants were enrolled from period 1, previous Group A.
FG00453 subjectsAs per ITT2 population, 53 participants were enrolled from period 1, previous Group A.
Excluded Site 138 Subjects From ITT2
Subjects from Site 138 were excluded from the analysis due to potential misconduct and noncompliance at this site.
FG0000 subjects
FG0017 subjects
FG0029 subjects
FG003
Completed Week 36
FG0000 subjects
FG00171 subjects
FG00279 subjects
FG00341 subjects
FG004
Completed Week 44
FG0000 subjects
FG00170 subjects
FG00275 subjects
FG00339 subjects
FG004
COMPLETED
FG0000 subjects
FG00170 subjects
FG00275 subjects
FG00339 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG00138 subjects
FG00233 subjects
FG00317 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG00122 subjects
FG00215 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group A
Period 1- Placebo BID for 12 Weeks
BG001
Group B
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
BG002
Group C
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000130
BG001134
BG002134
BG003398
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG000130
ParticipantsBG001134
ParticipantsBG002134
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000130
ParticipantsBG001134
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000130
ParticipantsBG001134
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000130
ParticipantsBG001134
ParticipantsBG002
Height
Baseline characteristic value is not available for all patients.
Mean
Standard Deviation
cm
Title
Denominators
Categories
ParticipantsBG000129
ParticipantsBG001134
ParticipantsBG002
Weight
Mean
Standard Deviation
kg
Title
Denominators
Categories
ParticipantsBG000130
ParticipantsBG001134
ParticipantsBG002
BMI
BMI - body mass index
Baseline characteristic value is not available for all patients.
IHS4- International HS Severity Scoring System 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 signified mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signified severe HS.
Mean
Standard Deviation
score on a scale
Title
Denominators
Categories
ParticipantsBG000130
ParticipantsBG001134
ParticipantsBG002
Subject's Global Assessment of Skin Pain NRS
NRS- numeric rating scale Subjects recorded the maximum severity pain on a numeric rating scale (NRS) from 0 (no skin pain) to 10 (skin pain as bad as can be imagined) in a daily diary from 1 week before day 1 through the week 44 visit.
Baseline characteristic value is not available for all patients.
Mean
Standard Deviation
score on a scale
Title
Denominators
Categories
ParticipantsBG000126
ParticipantsBG001129
Participants
Previous TNF Inhibitor Use
TNF- tumor necrosis factor
Count of Participants
Participants
Title
Denominators
Categories
Yes
ParticipantsBG000130
ParticipantsBG001134
ParticipantsBG002
Previously Started (allowed) Concomitant Antibiotic
Count of Participants
Participants
Title
Denominators
Categories
Yes
ParticipantsBG000130
ParticipantsBG001134
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
Posted
Number
percentage of participants
Baseline to Week 12
ID
Title
Description
OG000
Placebo
Placebo BID for 12 Weeks
OG001
Avacopan 10 mg
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
OG002
Avacopan 30 mg
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
Units
Counts
Participants
OG000130
OG001134
OG002134
Title
Denominators
Categories
Title
Measurements
OG00030.8
OG00122.4
OG00235.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.1321
P-values are obtained from a CMH test stratified by stratification factors Hurley Stage (Stage II vs III), and anti-TNF drug use (Treatment naive vs Previous treatment).
% Difference (Avacopan - Placebo)
-8.4
2-Sided
95
-18.7
2.4
Other
OG000
OG002
Secondary
Change From Baseline in Total AN Count at 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
Posted
Mean
Standard Deviation
percentage of ANs
Baseline to Week 12
ID
Title
Description
OG000
Placebo
Placebo BID for 12 Weeks
OG001
Avacopan 10 mg
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
OG002
Avacopan 30 mg
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
Units
Counts
Participants
Secondary
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
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
Posted
Number
number of responders
Baseline to Week 12
ID
Title
Description
OG000
Placebo
Placebo BID for 12 Weeks
OG001
Avacopan 10 mg
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
OG002
Avacopan 30 mg
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
Secondary
Area Under the Curve From Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 Plasma Concentration on 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
Posted
Mean
Standard Deviation
h*ng/mL
Day 1
ID
Title
Description
OG000
Avacopan 10 mg
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
OG001
Avacopan 30 mg
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
Units
Counts
Participants
OG000
Secondary
Number of Responders With Baseline Hurley Stage II Who Achieved an AN Count of 0, 1, or 2 at 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.
Posted
Number
number of responders
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Placebo BID for 12 Weeks
OG001
Avacopan 10 mg
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
OG002
Avacopan 30 mg
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
Units
Counts
Participants
Secondary
Change of IHS4 Score Relative to Baseline at 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
Posted
Mean
Standard Deviation
score on a scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Placebo BID for 12 Weeks
OG001
Avacopan 10 mg
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
OG002
Avacopan 30 mg
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
Units
Counts
Participants
Secondary
Change From Baseline in Inflammatory Nodule Count at 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.
Posted
Mean
Standard Deviation
count of inflammatory nodules
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Placebo BID for 12 Weeks
OG001
Avacopan 10 mg
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
OG002
Avacopan 30 mg
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Abscess Count at 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.
Posted
Mean
Standard Deviation
count of abscesses
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Placebo BID for 12 Weeks
OG001
Avacopan 10 mg
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
OG002
Avacopan 30 mg
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Draining Fistula Count at 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.
Posted
Mean
Standard Deviation
Draining Fistulae
Baseline and Week 2, Week 4, Week 8 and Week 12
ID
Title
Description
OG000
Placebo
Placebo BID for 12 Weeks
OG001
Avacopan 10 mg
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
OG002
Avacopan 30 mg
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
Units
Counts
Participants
OG000
Secondary
Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS
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.
Posted
Mean
Standard Deviation
score on a scale
Baseline and Week 2, Week 4, Week 8 and Week 12
ID
Title
Description
OG000
Placebo
Placebo BID for 12 Weeks
OG001
Avacopan 10 mg
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
OG002
Avacopan 30 mg
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
Time Frame
All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
Description
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo Period 1
Subjects randomized to placebo during period 1
0
129
3
129
22
129
EG001
Avacopan 10 mg Period 1
Avacopan 10 mg twice daily (BID) for Period 1 of the study
0
134
3
134
18
134
EG002
Avacopan 30 mg Period 1
Avacopan 30 mg twice daily (BID) for Period 1 of the study
0
135
1
135
15
135
EG003
Placebo to Avacopan 10 mg Period 2
Placebo population from Period 1 split into Placebo to Avacopan 10 mg twice daily (BID) for Period 2 of the study
0
56
0
56
7
56
EG004
Placebo to Avacopan 30 mg Period 2
Placebo population from Period 1 split into Placebo to Avacopan 30 mg twice daily (BID) for Period 2 of the study
0
52
1
52
8
52
EG005
Avacopan 10 mg Period 2
Avacopan 10 mg twice daily (BID) for Period 2 of the study
0
108
4
108
21
108
EG006
Avacopan 30 mg Period 2
Avacopan 30 mg twice daily (BID) for Period 2 of the study
Subject noncompliance with dosing or diary completion
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
Lost to Follow-up
FG0000 subjects
FG0018 subjects
FG00212 subjects
FG0031 subjects
FG0042 subjects
Noncompliance with the protocol
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
At the discretion of the investigator or sponsor for any reason
FG0000 subjects
FG0011 subjects
FG0023 subjects
FG0032 subjects
FG0043 subjects
Adverse Event
FG0000 subjects
FG0013 subjects
FG0021 subjects
FG0032 subjects
FG0042 subjects
COVID-19 Related
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
Reason not stated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
398
Title
Measurements
BG00036.9± 11.87
BG00136.0± 12.05
BG00236.8± 11.57
BG00336.6± 11.81
134
ParticipantsBG003398
Title
Measurements
Female
BG00023
BG00130
BG00228
BG00381
Male
BG000107
BG001104
BG002106
BG003317
134
ParticipantsBG003398
Title
Measurements
Hispanic or Latino
BG00031
BG00122
BG00239
BG00392
Not Hispanic or Latino
BG00099
BG001112
BG00295
BG003306
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
134
ParticipantsBG003398
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
Asian
BG0000
BG0011
BG0020
BG0031
Native Hawaiian or Other Pacific Islander
BG0001
BG0012
BG0020
BG0033
Black or African American
BG00043
BG00146
BG00234
BG003123
White
BG00083
BG00182
BG00296
BG003261
More than one race
BG0000
BG0010
BG0022
BG0032
Unknown or Not Reported
BG0003
BG0013
BG0022
BG0038
134
ParticipantsBG003397
Title
Measurements
BG000166.69± 8.696
BG001168.67± 9.852
BG002167.66± 9.021
BG003167.69± 9.221
134
ParticipantsBG003398
Title
Measurements
BG000102.48± 23.425
BG001103.02± 27.817
BG002103.46± 28.601
BG003102.99± 26.678
134
ParticipantsBG003397
Title
Measurements
BG00036.87± 8.824
BG00136.14± 8.728
BG00236.75± 9.384
BG00336.58± 8.969
134
ParticipantsBG003398
Title
Measurements
BG00085
BG00184
BG00287
BG003256
Stage III
ParticipantsBG000130
ParticipantsBG001134
ParticipantsBG002134
ParticipantsBG003398
Title
Measurements
BG00045
BG00150
BG00247
BG003
134
ParticipantsBG003398
Title
Measurements
BG00011.06± 10.275
BG00110.64± 8.733
BG00211.21± 9.521
BG00310.97± 9.502
134
ParticipantsBG003398
Title
Measurements
BG00011.6± 9.83
BG00113.5± 13.41
BG00212.3± 9.62
BG00312.5± 11.10
134
ParticipantsBG003398
Title
Measurements
BG0002.8± 3.83
BG0013.2± 4.15
BG0022.4± 3.73
BG0032.8± 3.91
134
ParticipantsBG003398
Title
Measurements
BG00029.6± 29.34
BG00133.8± 31.95
BG00230.0± 25.02
BG00331.2± 28.90
BG002
127
ParticipantsBG003382
Title
Measurements
BG0005.6± 2.52
BG0015.3± 2.54
BG0025.2± 2.47
BG0035.4± 2.51
134
ParticipantsBG003398
Title
Measurements
BG00035
BG00138
BG00236
BG003109
No
ParticipantsBG000130
ParticipantsBG001134
ParticipantsBG002134
ParticipantsBG003398
Title
Measurements
BG00095
BG00196
BG00298
BG003
134
ParticipantsBG003398
Title
Measurements
BG0008
BG0019
BG0027
BG00324
No
ParticipantsBG000130
ParticipantsBG001134
ParticipantsBG002134
ParticipantsBG003398
Title
Measurements
BG000122
BG001125
BG002127
BG003
Cochran-Mantel-Haenszel
0.4503
P-values are obtained from a CMH test stratified by stratification factors Hurley Stage (Stage II vs III), and anti-TNF drug use (Treatment naive vs Previous treatment)