Hidradenitis Suppurativa Phase 2b Study of Izokibep | NCT05355805 | Trialant
NCT05355805
Sponsor
ACELYRIN Inc.
Status
Completed
Last Update Posted
Jun 3, 2025Actual
Enrollment
205Actual
Phase
Phase 2
Conditions
Hidradenitis Suppurativa
Interventions
Izokibep
Placebo to izokibep
Countries
United States
Canada
Germany
Hungary
Poland
Spain
Protocol Section
Identification Module
NCT ID
NCT05355805
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
21102
Secondary IDs
ID
Type
Description
Link
2021-005713-13
EudraCT Number
Brief Title
Hidradenitis Suppurativa Phase 2b Study of Izokibep
Official Title
A Phase 2b Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Moderate to Severe Hidradenitis Suppurativa
Acronym
Not provided
Organization
ACELYRIN Inc.INDUSTRY
Status Module
Record Verification Date
Mar 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
May 5, 2022Actual
Primary Completion Date
Aug 2, 2023Actual
Completion Date
Feb 21, 2024Actual
First Submitted Date
Apr 12, 2022
First Submission Date that Met QC Criteria
Apr 28, 2022
First Posted Date
May 2, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Jul 19, 2024
Results First Submitted that Met QC Criteria
Sep 16, 2024
Results First Posted Date
Sep 25, 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
May 16, 2025
Last Update Posted Date
Jun 3, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ACELYRIN Inc.INDUSTRY
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
Izokibep is a potent and selective inhibitor of interleukin 17A (IL-17A) that is being developed for treatment of hidradenitis suppurativa (HS).
This study will evaluate the efficacy, safety, and immunogenicity of izokibep administered subcutaneously (SC) in adult subjects with moderate to severe HS.
Detailed Description
Not provided
Conditions Module
Conditions
Hidradenitis Suppurativa
Keywords
hidradenitis suppurativa
Izokibep
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
205Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A (Open-label) izokibep every week
Experimental
Participants will receive izokibep every week from Day 1 through Week 31
Drug: Izokibep
Part B (Double-blind) izokibep every week
Experimental
Participants will receive izokibep every week for 31 weeks.
Drug: Izokibep
Part B (Double-blind) izokibep every other week
Experimental
Participants will receive izokibep every other week for 30 weeks.
Drug: Izokibep
Part B (Double-blind) placebo every week
Placebo Comparator
Participants will receive placebo every week up to Week 15, then izokibep from Week 16 to Week 31.
Drug: Placebo to izokibep
Part B (Double-blind) placebo every other week
Placebo Comparator
Participants will receive placebo every other week up to Week 14, then izokibep from Week 16 to Week 30.
Drug: Placebo to izokibep
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Izokibep
Drug
Biologic: IL-17A inhibitor
Form: Solution for injection
Route of administration: Subcutaneous (SC)
Part A (Open-label) izokibep every week
Part B (Double-blind) izokibep every other week
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part A: Number of Participants Who Achieved Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12
HiSCR75 was defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.
Part A: Baseline to Week 12
Part B: Number of Participants Who Achieved HiSCR75 at Week 16
HiSCR75 was defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.
Part B: Baseline to Week 16
Secondary Outcomes
Measure
Description
Time Frame
Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) referred to any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. Serious TEAEs (SAEs) were untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
General
Subject has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
18 years to 75 years of age
Type of Subject and Disease Characteristics
Diagnosis of hidradenitis suppurativa (HS) for ≥ 1 year prior to first dose of study drug.
Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas, one of which is Hurley Stage II or III.
A total abscess and inflammatory nodule (AN) count of ≥ 5 at screening and Day 1 prior to enrollment/randomization.
Subject must have had an inadequate response to oral antibiotics OR exhibited recurrence after discontinuation to, OR demonstrated intolerance to, OR have a contraindication to oral antibiotics for treatment of their HS.
Must agree to use daily over-the-counter topical antiseptics.
Subject must be willing to complete a daily skin pain diary for at least 3 days prior to Day 1 visit.
Exclusion Criteria:
Medical Conditions
Draining fistula count of > 20.
Outpatient surgery ≤ 8 weeks prior or inpatient surgery ≤ 12 weeks prior to enrollment/randomization.
Other active skin disease or condition that could interfere with study assessments.
Chronic pain not associated with HS.
Uncontrolled, clinically significant system disease.
History of demyelinating disease or neurological symptoms suggestive of demyelinating disease.
Malignancy within 5 years.
The subject is at risk of self-harm or harm to others.
Active infection or history of certain infections.
Tuberculosis or fungal infection seen on available chest x-ray taken ≤ 3 months of screening or at screening (Exception: documented evidence of completed treatment and clinically resolved).
Known history of human immunodeficiency virus (HIV).
Other protocol defined inclusion/exclusion criteria may apply.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Donald Betah, MD
ACELYRIN Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Clinical Research Site
Birmingham
Alabama
35233-3110
United States
Clinical Research Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Undecided
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Part A was a single-arm, open-label, proof-of-concept investigation to explore preliminary efficacy and safety of izokibep.
Once Part A was fully enrolled, subsequent participants were enrolled into Part B.
Part B was a randomized, double-blind, placebo-controlled, parallel-group, dose-finding investigation to evaluate the efficacy, safety, and immunogenicity of izokibep in participants with moderate to severe hidradenitis suppurativa.
Recruitment Details
Participants were recruited at different centers in the United States, Canada, Germany, Hungary, Poland, and Spain, and participated from May 2022 to February 2024.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A Izokibep 160 mg QW (Open-label)
Participants with moderate to severe Hidradenitis Suppurativa (HS) received open label izokibep 160 mg by subcutaneous (SC) injection once every week (QW) in Part A for up to 31 weeks.
FG001
Part B Placebo QW/Q2W Then Izokibep QW/Q2W
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
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
Dec 13, 2023
Jun 4, 2024
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
No data available
No data is available for this block.
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
Part B (Double-blind) izokibep every week
Placebo to izokibep
Drug
Form: Solution for injection
Route of administration: Subcutaneous (SC)
Part B (Double-blind) placebo every other week
Part B (Double-blind) placebo every week
Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks
Part A: Number of Participants Testing Positive for Anti-drug Antibodies (ADAs)
Blood samples were collected at different time points throughout the study.
Baseline, Week 16, Week 32, Week 39
Part B: Number of Participants Who Achieved HiSCR90 at Week 16
HiSCR90 was defined as at least a 90% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count
Part B: Baseline to Week 16
Part B: Number of Participants Who Achieved HiSCR100 at Week 16
HiSCR100 was defined as at least a 100% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.
Part B: Baseline to Week 16
Part B: Number of Participants Who Achieved HiSCR50 at Week 16
HiSCR50 was defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count
Part B: Baseline to Week 16
Part B: Percentage of Participants Who Experienced ≥ 1 Disease Flare Through 16 Weeks of Treatment
A flare was defined as ≥ 25% increase in AN count with a minimum increase of 2 AN relative to baseline.
Missing data of abscess and inflammatory nodules counts at scheduled visits are imputed assuming monotone missingness pattern. Predictors in the regression model for missing values at Week 4 are Baseline Hurley stage, baseline abscess count, baseline inflammatory nodule count, baseline draining fistula count, sex, race, age, body mass index (BMI) and prior Biologic/JAK inhibitor use for HS. Predictors in the regression model for missing values after Week 4 are all of these variables, plus counts of abscess, inflammatory nodule, and draining fistula at prior scheduled assessment. Missing flare values in both the placebo and izokibep groups are imputed using observed data from the placebo group only.
Part B: Day 1 through to Week 16
Part B: Number of Participants With Hurley Stage II at Baseline Who Achieved AN Count of 0, 1, or 2
The percentage of participants with baseline Hurley Stage II who achieved AN count of 0, 1, or 2 at Week 16.
Hurley stages:
Stage 1 - solitary or multiple, isolated abscess formation without scarring or sinus tracts Stage 2 - recurrent abscesses, single or multiple widely separated lesions, with sinus tract formation Stage 3 - diffuse or broad involvement, with multiple interconnected sinus tracts and abscesses.
Part B: Week 16
Part B: Number of Participants Who Achieved at Least a 3-Point Reduction From Baseline in Numeric Rating Scale (NRS) in Patient Global Assessment of Skin Pain at Its Worst at Week 16 Among Participants With Baseline NRS ≥ 4
The Patient Global Assessment of Skin Pain is a NRS that consists of scores from 0 to 10 with 0 indicating "no skin pain" and 10 indicating "pain as bad as you can imagine".
Part B: Baseline to Week 16
Part B: Number of Participants With TEAEs of Special Interest
Adverse events of special interest were adverse events in the following categories: candida infection, inflammatory bowel disease, suicidal ideation, malignancies, major cardiovascular and cerebrovascular events, tuberculosis, infections, cytopenias and hypersensitivity reactions.
Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks
Part B: Number of Participants With TEAEs
An AE referred to any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. SAEs were untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events.
Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks
Part B: Number of Participants Testing Positive for ADAs
Blood samples were collected at different time points throughout the study.
Up to 39 weeks
Encino
California
91436-2428
United States
Clinical Research Site
Fountain Valley
California
92708-3701
United States
Clinical Research Site
Los Angeles
California
90033
United States
Clinical Research Site
Los Angeles
California
90045-3606
United States
Clinical Research Site
Ocala
Florida
34470
United States
Clinical Research Site
Tampa
Florida
33624-2038
United States
Clinical Research Site
Sandy Springs
Georgia
30328
United States
Clinical Research Site
Savannah
Georgia
31406
United States
Clinical Research Site
Rolling Meadows
Illinois
60008-3811
United States
Clinical Research Site
Indianapolis
Indiana
46250
United States
Clinical Research Site
Plainfield
Indiana
46168
United States
Clinical Research Site
Murray
Kentucky
42071-2515
United States
Clinical Research Site
Baton Rouge
Louisiana
70808
United States
Clinical Research Site
New York
New York
10028-3001
United States
Clinical Research Site
Mason
Ohio
45040-4520
United States
Clinical Research Site
Portland
Oregon
97223
United States
Clinical Research Site
Philadelphia
Pennsylvania
19103-4708
United States
Clinical Research Site
Pittsburgh
Pennsylvania
15213-3403
United States
Clinical Research Site
Webster
Texas
77598
United States
Clinical Research Site
London
Ontario
N6A 2C2
Canada
Clinical Research Site
Markham
Ontario
L3P 1X2
Canada
Clinical Research Site
Waterloo
Ontario
N2J 1C4
Canada
Clinical Research Site
Québec
Quebec
G1N 4V3
Canada
Clinical Research Site
Saskatoon
Saskatchewan
S7K 2C1
Canada
Clinical Research Site
Bad Bentheim
Lower Saxony
48455
Germany
Clinical Research Site
Bochum
Northwest
44791
Germany
Clinical Research Site
Kiel
Schleswig-Holstein
24105
Germany
Clinical Research Site
Kiel
Schleswig-Holstein
24148
Germany
Clinical Research Site
Schwerin
19055
Germany
Clinical Research Site
Budapest
BU
1036
Hungary
Clinical Research Site
Debrecen
HB
4032
Hungary
Clinical Research Site
Krakow
Lesser Poland Voivodeship
30-510
Poland
Clinical Research Site
Krakow
Lesser Poland Voivodeship
31-147
Poland
Clinical Research Site
Wroclaw
Lower Silesian Voivodeship
50-566
Poland
Clinical Research Site
Wroclaw
Lower Silesian Voivodeship
51-318
Poland
Clinical Research Site
Bialystok
Podlaskie Voivodeship
15-453
Poland
Clinical Research Site
Katowice
Silesian Voivodeship
40-615
Poland
Clinical Research Site
Lublin
20-573
Poland
Clinical Research Site
Szczecin
70-332
Poland
Clinical Research Site
Palma de Mallorca
PM
07120
Spain
Clinical Research Site
Pontevedra
PO
36001
Spain
Clinical Research Site
Manises
V
46940
Spain
Clinical Research Site
Barcelona
8036
Spain
Participants with moderate to severe HS received placebo by SC injection either QW or every 2 weeks (Q2W) up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W for up to Week 30.
FG002
Part B Izokibep 160 mg QW
Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.
FG003
Part B Izokibep 160 mg Q2W
Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.
FG00030 subjects
FG00159 subjects
FG00257 subjects
FG00359 subjects
Switched to Izokibep 160 mg QW
FG0000 subjects
FG00124 subjects
FG0020 subjects
FG0030 subjects
Switched to Izokibep 160 mg Q2W
FG0000 subjects
FG00126 subjects
FG0020 subjects
FG0030 subjects
COMPLETED
FG00017 subjects
FG00134 subjects
FG00231 subjects
FG00340 subjects
NOT COMPLETED
FG00013 subjects
FG00125 subjects
FG00226 subjects
FG00319 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0006 subjects
FG00111 subjects
FG00210 subjects
FG0036 subjects
Decision by Sponsor
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Withdrawal by Subject
FG0007 subjects
FG00114 subjects
FG00215 subjects
FG00313 subjects
Full Analysis Set (FAS), Part A: all participants who received at lease one dose of study drug in Part A.
FAS, Part B: all participants randomized in Part B.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A Izokibep 160 mg QW
Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.
BG001
Part B Placebo QW/Q2W Then Izokibep QW/Q2W
Participants with moderate to severe HS received placebo by SC injection either QW or Q2W for up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W up to Week 30.
BG002
Part B Izokibep 160 mg QW
Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.
BG003
Part B Izokibep 160 mg Q2W
Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00030
BG00159
BG00257
BG00359
BG004205
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Participants in Part A and Part B of the study were analyzed separately
Count of Participants
Participants
Title
Denominators
Categories
Part A
ParticipantsBG00030
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG003
Age, Continuous
Participants in Part A and Part B of the study were analyzed separately
Mean
Standard Deviation
years
Title
Denominators
Categories
Part A
ParticipantsBG00030
ParticipantsBG0010
ParticipantsBG002
Sex: Female, Male
Participants in Part A and Part B of the study were analyzed separately
Count of Participants
Participants
Title
Denominators
Categories
Part A
ParticipantsBG00030
ParticipantsBG0010
ParticipantsBG002
Ethnicity (NIH/OMB)
Participants in Part A and Part B of the study were analyzed separately
Count of Participants
Participants
Title
Denominators
Categories
Part A
ParticipantsBG00030
ParticipantsBG0010
ParticipantsBG002
Race (NIH/OMB)
Participants in Part A and Part B of the study were analyzed separately
Count of Participants
Participants
Title
Denominators
Categories
Part A
ParticipantsBG00030
ParticipantsBG0010
ParticipantsBG002
Abscess Count
Participants in Part A and Part B of the study were analyzed separately
Mean
Standard Deviation
Abcesses
Title
Denominators
Categories
Part A
ParticipantsBG00030
ParticipantsBG0010
ParticipantsBG002
Inflammatory Nodule Count
Participants in Part A and Part B of the study were analyzed separately
Mean
Standard Deviation
Nodules
Title
Denominators
Categories
Part A
ParticipantsBG00030
ParticipantsBG0010
ParticipantsBG002
Draining Fistula Count
Participants in Part A and Part B of the study were analyzed separately
Mean
Standard Deviation
Fistulas
Title
Denominators
Categories
Part A
ParticipantsBG00030
ParticipantsBG0010
ParticipantsBG002
Abcess and Inflammatory Nodule (AN) Count
Participants in Part A and Part B of the study were analyzed separately
Mean
Standard Deviation
Total Abcess/Nodules
Title
Denominators
Categories
Part A
ParticipantsBG00030
ParticipantsBG0010
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
Part A: Number of Participants Who Achieved Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12
HiSCR75 was defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.
FAS, Part A: all participants who received at lease one dose of study drug in Part A.
Posted
Count of Participants
Participants
Part A: Baseline to Week 12
ID
Title
Description
OG000
Part A Izokibep 160 mg QW
Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.
Units
Counts
Participants
OG00030
Title
Denominators
Categories
Title
Measurements
OG00012
Primary
Part B: Number of Participants Who Achieved HiSCR75 at Week 16
HiSCR75 was defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.
FAS, Part B: all participants randomized in Part B.
Posted
Count of Participants
Participants
Part B: Baseline to Week 16
ID
Title
Description
OG000
Part B Placebo QW/Q2W Then Izokibep QW/Q2W
Participants with moderate to severe HS received placebo by SC injection either QW or Q2W for up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W up to Week 30.
OG001
Part B Izokibep 160 mg QW
Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.
OG002
Part B Izokibep 160 mg Q2W
Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.
Secondary
Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) referred to any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. Serious TEAEs (SAEs) were untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events.
Safety analysis set (SAS): all participants who received at lease one dose of study drug in Part A.
Posted
Count of Participants
Participants
Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks
ID
Title
Description
OG000
Part A Izokibep 160 mg QW
Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.
Units
Counts
Participants
Secondary
Part A: Number of Participants Testing Positive for Anti-drug Antibodies (ADAs)
Blood samples were collected at different time points throughout the study.
ADA Analysis Set: all participants who received at lease one dose of study drug and had both baseline ADA and at least one post-dose ADA measurement in Part A.
Posted
Count of Participants
Participants
Baseline, Week 16, Week 32, Week 39
ID
Title
Description
OG000
Part A Izokibep 160 mg QW
Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.
Units
Counts
Participants
OG000
Secondary
Part B: Number of Participants Who Achieved HiSCR90 at Week 16
HiSCR90 was defined as at least a 90% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count
FAS, Part B: all participants randomized in Part B.
Posted
Count of Participants
Participants
Part B: Baseline to Week 16
ID
Title
Description
OG000
Part B Placebo QW/Q2W Then Izokibep QW/Q2W
Participants with moderate to severe HS received placebo by SC injection either QW or Q2W for up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W up to Week 30.
OG001
Part B Izokibep 160 mg QW
Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.
OG002
Part B Izokibep 160 mg Q2W
Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.
Secondary
Part B: Number of Participants Who Achieved HiSCR100 at Week 16
HiSCR100 was defined as at least a 100% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.
FAS, Part B: all participants randomized in Part B.
Posted
Count of Participants
Participants
Part B: Baseline to Week 16
ID
Title
Description
OG000
Part B Placebo QW/Q2W Then Izokibep QW/Q2W
Participants with moderate to severe HS received placebo by SC injection either QW or Q2W up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W up to Week 30.
OG001
Part B Izokibep 160 mg QW
Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.
OG002
Part B Izokibep 160 mg Q2W
Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.
Secondary
Part B: Number of Participants Who Achieved HiSCR50 at Week 16
HiSCR50 was defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count
FAS, Part B: all participants randomized in Part B.
Posted
Count of Participants
Participants
Part B: Baseline to Week 16
ID
Title
Description
OG000
Part B Placebo QW/Q2W Then Izokibep QW/Q2W
Participants with moderate to severe HS received placebo by SC injection either QW or Q2W up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W up to Week 30.
OG001
Part B Izokibep 160 mg QW
Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.
OG002
Part B Izokibep 160 mg Q2W
Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.
Secondary
Part B: Percentage of Participants Who Experienced ≥ 1 Disease Flare Through 16 Weeks of Treatment
A flare was defined as ≥ 25% increase in AN count with a minimum increase of 2 AN relative to baseline.
Missing data of abscess and inflammatory nodules counts at scheduled visits are imputed assuming monotone missingness pattern. Predictors in the regression model for missing values at Week 4 are Baseline Hurley stage, baseline abscess count, baseline inflammatory nodule count, baseline draining fistula count, sex, race, age, body mass index (BMI) and prior Biologic/JAK inhibitor use for HS. Predictors in the regression model for missing values after Week 4 are all of these variables, plus counts of abscess, inflammatory nodule, and draining fistula at prior scheduled assessment. Missing flare values in both the placebo and izokibep groups are imputed using observed data from the placebo group only.
FAS, Part B: all participants randomized in Part B.
Posted
Number
95% Confidence Interval
Percentage of participants
Part B: Day 1 through to Week 16
ID
Title
Description
OG000
Part B Placebo QW/Q2W Then Izokibep QW/Q2W
Participants with moderate to severe HS received placebo by SC injection either QW or Q2W up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W up to Week 30.
OG001
Part B Izokibep 160 mg QW
Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.
Secondary
Part B: Number of Participants With Hurley Stage II at Baseline Who Achieved AN Count of 0, 1, or 2
The percentage of participants with baseline Hurley Stage II who achieved AN count of 0, 1, or 2 at Week 16.
Hurley stages:
Stage 1 - solitary or multiple, isolated abscess formation without scarring or sinus tracts Stage 2 - recurrent abscesses, single or multiple widely separated lesions, with sinus tract formation Stage 3 - diffuse or broad involvement, with multiple interconnected sinus tracts and abscesses.
FAS, Part B: all participants randomized in Part B, inclusive only of participants with Hurley Stage II at baseline.
Posted
Count of Participants
Participants
Part B: Week 16
ID
Title
Description
OG000
Part B Placebo QW/Q2W Then Izokibep QW/Q2W
Participants with moderate to severe HS received placebo by SC injection either QW or Q2W up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W up to Week 30.
OG001
Part B Izokibep 160 mg QW
Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.
OG002
Part B Izokibep 160 mg Q2W
Secondary
Part B: Number of Participants Who Achieved at Least a 3-Point Reduction From Baseline in Numeric Rating Scale (NRS) in Patient Global Assessment of Skin Pain at Its Worst at Week 16 Among Participants With Baseline NRS ≥ 4
The Patient Global Assessment of Skin Pain is a NRS that consists of scores from 0 to 10 with 0 indicating "no skin pain" and 10 indicating "pain as bad as you can imagine".
FAS, Part B: all participants randomized in Part B who had a baseline NRS ≥ 4.
Posted
Count of Participants
Participants
Part B: Baseline to Week 16
ID
Title
Description
OG000
Part B Placebo QW/Q2W Then Izokibep QW/Q2W
Participants with moderate to severe HS received placebo by SC injection either QW or Q2W up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W up to Week 30.
OG001
Part B Izokibep 160 mg QW
Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.
OG002
Part B Izokibep 160 mg Q2W
Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.
Secondary
Part B: Number of Participants With TEAEs of Special Interest
Adverse events of special interest were adverse events in the following categories: candida infection, inflammatory bowel disease, suicidal ideation, malignancies, major cardiovascular and cerebrovascular events, tuberculosis, infections, cytopenias and hypersensitivity reactions.
SAS: all randomized participants who received at least one dose of study drug in Part B.
Posted
Count of Participants
Participants
Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks
ID
Title
Description
OG000
Part B Placebo QW/Q2W (Up to Week 16)
Participants with moderate to severe HS received placebo by SC injection either QW or Q2W for up to 16 weeks.
OG001
Part B Izokibep 160 mg Q2W (Up to Week 16)
Participants received izokibep Q2W in a blinded manor for 16 weeks.
OG002
Part B Izokibep 160 mg QW (Up to Week 16)
Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 16 weeks.
OG003
Part B Placebo/Izokibep 160 mg QW (Week 16 to 31)
Secondary
Part B: Number of Participants With TEAEs
An AE referred to any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. SAEs were untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events.
SAS: all randomized participants who received at least one dose of study drug in Part B.
Posted
Count of Participants
Participants
Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks
ID
Title
Description
OG000
Part B Placebo QW/Q2W (Up to Week 16)
Participants with moderate to severe HS received placebo by SC injection either QW or Q2W for up to 16 weeks.
OG001
Part B Izokibep 160 mg QW (Up to Week 16)
Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 16 weeks.
OG002
Part B Izokibep 160 mg Q2W (Up to Week 16)
Secondary
Part B: Number of Participants Testing Positive for ADAs
Blood samples were collected at different time points throughout the study.
ADA Analysis Set: all participants who received at lease one dose of study drug and had both baseline ADA and at least one post-dose ADA measurement in Part B.
Posted
Count of Participants
Participants
Up to 39 weeks
ID
Title
Description
OG000
Part B Placebo QW/Q2W Then Izokibep QW/Q2W
Participants with moderate to severe HS received placebo by SC injection either QW or Q2W up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W up to Week 30.
OG001
Part B Izokibep 160 mg QW
Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.
OG002
Part B Izokibep 160 mg Q2W
Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.
Time Frame
Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks.
Description
SAS: all randomized participants who received at least one dose of study drug.
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
Part A Izokibep 160 mg QW
Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.
0
30
2
30
25
30
EG001
Part B Placebo QW/Q2W (Up to Week 16)
Participants with moderate to severe HS received placebo by SC injection either QW or Q2W for up to 16 weeks.
0
59
2
59
25
59
EG002
Part B Izokibep 160 mg QW - (Up to Week 16)
Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 16 weeks.
0
57
2
57
43
57
EG003
Part B Izokibep 160 mg Q2W (Up to Week 16)
Participants received izokibep Q2W in a blinded manor for 16 weeks.
0
59
1
59
34
59
EG004
Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30)
Participants received izokibep Q2W in a blinded manor for weeks 16-30.
0
26
1
26
10
26
EG005
Part B Placebo/Izokibep 160 mg QW (Week 16 to 31)
Participants received izokibep QW in a blinded manor for weeks 16-31.
0
24
2
24
14
24
EG006
Part B: Izokibep 160 mg Q2W (Week 16 to 30)
Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection during weeks 16-30.
0
53
0
53
9
53
EG007
Part B: Izokibep 160 mg QW (Week 16 to 31)
Participants with moderate to severe HS received izokibep 160 mg QW by SC injection during weeks 16-31.
0
43
1
43
13
43
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Epstein-Barr virus infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected59 at risk
EG0021 events1 affected57 at risk
EG0030 affected59 at risk
EG004
Scrotal abscess
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 events1 affected59 at risk
EG0020 affected57 at risk
EG003
Sepsis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected59 at risk
EG0020 affected57 at risk
EG003
Wound infection staphylococcal
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 events1 affected59 at risk
EG0020 affected57 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected59 at risk
EG0021 events1 affected57 at risk
EG003
Cutaneous vasculitis
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected59 at risk
EG0021 events1 affected57 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected59 at risk
EG0020 affected57 at risk
EG003
Colonic abscess
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 affected59 at risk
EG0020 affected57 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 affected59 at risk
EG0020 affected57 at risk
EG003
Still's disease
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected59 at risk
EG0020 affected57 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected59 at risk
EG0020 affected57 at risk
EG003
Multiple sclerosis
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected59 at risk
EG0020 affected57 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Injection site erythema
General disorders
MedDRA (26.1)
Systematic Assessment
EG00038 events12 affected30 at risk
EG0010 affected59 at risk
EG00259 events31 affected57 at risk
EG00344 events23 affected59 at risk
EG00412 events7 affected26 at risk
EG00575 events12 affected24 at risk
EG00615 events5 affected53 at risk
EG00717 events3 affected43 at risk
Injection site pruritus
General disorders
MedDRA (26.1)
Systematic Assessment
EG00023 events8 affected30 at risk
EG0010 affected59 at risk
EG00230 events16 affected57 at risk
EG003
Injection site swelling
General disorders
MedDRA (26.1)
Systematic Assessment
EG00019 events6 affected30 at risk
EG0010 affected59 at risk
EG00212 events9 affected57 at risk
EG003
Injection site warmth
General disorders
MedDRA (26.1)
Systematic Assessment
EG0006 events5 affected30 at risk
EG0010 affected59 at risk
EG0022 events1 affected57 at risk
EG003
Injection site reaction
General disorders
MedDRA (26.1)
Systematic Assessment
EG00013 events4 affected30 at risk
EG0010 affected59 at risk
EG0027 events1 affected57 at risk
EG003
Injection site pain
General disorders
MedDRA (26.1)
Systematic Assessment
EG0009 events3 affected30 at risk
EG00114 events1 affected59 at risk
EG00219 events3 affected57 at risk
EG003
Injection site induration
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected59 at risk
EG0020 affected57 at risk
EG003
COVID-19
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0002 events2 affected30 at risk
EG0012 events2 affected59 at risk
EG0021 events1 affected57 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0002 events2 affected30 at risk
EG0010 affected59 at risk
EG0020 affected57 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0002 events2 affected30 at risk
EG0011 events1 affected59 at risk
EG0021 events1 affected57 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0002 events2 affected30 at risk
EG0011 events1 affected59 at risk
EG0022 events2 affected57 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (26.1)
Systematic Assessment
EG0002 events2 affected30 at risk
EG0011 events1 affected59 at risk
EG0020 affected57 at risk
EG003
Headache
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected30 at risk
EG00115 events8 affected59 at risk
EG00213 events8 affected57 at risk
EG003
Hypertension
Vascular disorders
MedDRA (26.1)
Systematic Assessment
EG0002 events2 affected30 at risk
EG0014 events3 affected59 at risk
EG0020 affected57 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 events1 affected59 at risk
EG0023 events3 affected57 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected30 at risk
EG0016 events5 affected59 at risk
EG00210 events9 affected57 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected30 at risk
EG0017 events6 affected59 at risk
EG0026 events5 affected57 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected30 at risk
EG0014 events4 affected59 at risk
EG0021 events1 affected57 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected30 at risk
EG0012 events2 affected59 at risk
EG0023 events3 affected57 at risk
EG003
Migraine
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected59 at risk
EG0022 events1 affected57 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected30 at risk
EG0012 events2 affected59 at risk
EG0021 events1 affected57 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Per Clinical Trial Agreements, sites may not publish study results without sponsor's written consent:
sponsor has right to first publication
after first publication, site may publish if sponsor is given 60 days to review for confidential/proprietary information
if publication may impact sponsor rights (eg, a patent), sponsor may request 90-day delay
if sponsor does not publish within 12 months after study end or confirms they will not, site may publish, subject to sponsor's rights above
The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/Janus Kinase (JAK) inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error was estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.
Non-response imputation was used for participants with missing HiSCR75.
Cochran-Mantel-Haenszel
0.3055
The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.
Risk Difference (RD)
8.27
Standard Error of the Mean
8.075
2-Sided
Superiority
OG000
OG002
The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error was estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.
Non-response imputation was used for participants with missing HiSCR75.
Cochran-Mantel-Haenszel
0.6192
The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.
Risk Difference (RD)
4.19
Standard Error of the Mean
8.427
2-Sided
Superiority
OG00030
Title
Denominators
Categories
Any TEAE
Title
Measurements
OG00026
Serious TEAE
Title
Measurements
OG0002
25
Title
Denominators
Categories
Baseline
ParticipantsOG00025
Title
Measurements
OG00012
Week 16
ParticipantsOG00018
Title
Measurements
OG00011
Week 32
ParticipantsOG00018
Title
Measurements
OG00015
Week 39
ParticipantsOG00018
Title
Measurements
OG00017
Units
Counts
Participants
OG00059
OG00157
OG00259
Title
Denominators
Categories
Title
Measurements
OG0009
OG00115
OG00212
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
The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.
Non-response imputation was used for participants with missing HiSCR90.
Cochran-Mantel-Haenszel
0.1606
The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.
Risk Difference (RD)
10.14
Standard Error of the Mean
7.229
2-Sided
Superiority
OG000
OG002
The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.
Non-response imputation was used for participants with missing HiSCR90.
Cochran-Mantel-Haenszel
0.5116
The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.
Risk Difference (RD)
4.79
Standard Error of the Mean
7.294
2-Sided
Superiority
Units
Counts
Participants
OG00059
OG00157
OG00259
Title
Denominators
Categories
Title
Measurements
OG0007
OG00115
OG00211
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
The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.
Non-response imputation was used for participants with missing HiSCR100.
Cochran-Mantel-Haenszel
0.0514
The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.
Risk Difference (RD)
13.67
Standard Error of the Mean
7.019
2-Sided
Superiority
OG000
OG002
The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.
Non-response imputation was used for participants with missing HiSCR100.
Cochran-Mantel-Haenszel
0.3322
The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.
Risk Difference (RD)
6.56
Standard Error of the Mean
6.764
2-Sided
Superiority
Units
Counts
Participants
OG00059
OG00157
OG00259
Title
Denominators
Categories
Title
Measurements
OG00022
OG00126
OG00226
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
The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.
Non-response imputation was used for participants with missing HiSCR50.
Cochran-Mantel-Haenszel
0.3258
The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.
Risk Difference (RD)
8.63
Standard Error of the Mean
8.780
2-Sided
Superiority
OG000
OG002
The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.
Non-response imputation was used for participants with missing HiSCR50.
Cochran-Mantel-Haenszel
0.4068
The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.
Risk Difference (RD)
7.28
Standard Error of the Mean
8.775
2-Sided
Superiority
OG002
Part B Izokibep 160 mg Q2W
Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.
Units
Counts
Participants
OG00059
OG00157
OG00259
Title
Denominators
Categories
Title
Measurements
OG00022.32(11.7 to 32.9)
OG00118.29(8.43 to 28.1)
OG00214.93(5.72 to 24.1)
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
The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.
Missing data of abscess and inflammatory nodules counts at scheduled visits are imputed assuming monotone missingness pattern.
Cochran-Mantel-Haenszel
0.3329
The estimated risk difference divided by the standard error will be used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.
Risk Difference (RD)
-7.40
Standard Error of the Mean
7.661
2-Sided
Superiority
Predictors in the regression model for missing values at Week 16 are Baseline Hurley stage, baseline abscess count, baseline inflammatory nodule count, baseline draining fistula count, sex, race, age, BMI and Prior Biologic/JAK inhibitor use for HS plus counts of abscess, inflammatory nodule, and draining fistula at prior scheduled assessment. Missing flare values in both the placebo and izokibep groups are imputed using observed data from the placebo group only.
OG000
OG002
The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.
Missing data of abscess and inflammatory nodules counts at scheduled visits are imputed assuming monotone missingness pattern.
Cochran-Mantel-Haenszel
0.5882
The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.
Risk Difference (RD)
4.06
Standard Error of the Mean
7.574
2-Sided
Superiority
Predictors in the regression model for missing values at Week 16 are Baseline Hurley stage, baseline abscess count, baseline inflammatory nodule count, baseline draining fistula count, sex, race, age, BMI and Prior Biologic/JAK inhibitor use for HS plus counts of abscess, inflammatory nodule, and draining fistula at prior scheduled assessment. Missing flare values in both the placebo and izokibep groups are imputed using observed data from the placebo group only.
Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.
Units
Counts
Participants
OG00034
OG00135
OG00236
Title
Denominators
Categories
Title
Measurements
OG00015
OG00118
OG00214
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
The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.
Cochran-Mantel-Haenszel
0.5422
The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.
Risk Difference (RD)
7.31
Standard Error of the Mean
11.995
2-Sided
Superiority
OG000
OG002
The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.
Cochran-Mantel-Haenszel
0.6569
The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.
Risk Difference (RD)
-5.23
Standard Error of the Mean
11.770
2-Sided
Superiority
Units
Counts
Participants
OG00031
OG00129
OG00229
Title
Denominators
Categories
Title
Measurements
OG0004
OG0015
OG0029
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
The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.
Cochran-Mantel-Haenszel
0.4031
The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.
Risk Difference (RD)
7.48
Standard Error of the Mean
8.951
2-Sided
Superiority
OG000
OG002
The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.
Cochran-Mantel-Haenszel
0.0327
The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.
Risk Difference (RD)
21.27
Standard Error of the Mean
9.959
2-Sided
Superiority
Participants received izokibep QW in a blinded manor for weeks 16-31.
OG004
Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30)
Participants received izokibep Q2W in a blinded manor for weeks 16-30.
OG005
Part B: Izokibep 160 mg QW (Week 16 to 31)
Participants with moderate to severe HS received izokibep 160 mg QW by SC injection during weeks 16-31.
OG006
Part B: Izokibep 160 mg Q2W (Week 16 to 30)
Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection during weeks 16-30.
Units
Counts
Participants
OG00059
OG00159
OG00257
OG00324
OG00426
OG00543
OG00653
Title
Denominators
Categories
Title
Measurements
OG0004
OG0012
OG0021
OG0031
OG0042
OG0050
OG0062
Participants received izokibep Q2W in a blinded manor for 16 weeks.
OG003
Part B Placebo/Izokibep 160 mg QW (Week 16 to 31)
Participants received izokibep QW in a blinded manor for weeks 16-31.
OG004
Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30)
Participants received izokibep Q2W in a blinded manor for weeks 16-30.
OG005
Part B: Izokibep 160 mg QW (Week 16 to 31)
Participants with moderate to severe HS received izokibep 160 mg QW by SC injection during weeks 16-31.
OG006
Part B: Izokibep 160 mg Q2W (Week 16 to 30)
Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection during weeks 16-30.