A Study to Evaluate the Efficacy and Safety of Imsidolima... | NCT04856930 | Trialant
NCT04856930
Sponsor
Vanda Pharmaceuticals
Status
Completed
Last Update Posted
Sep 22, 2025Actual
Enrollment
149Actual
Phase
Phase 2
Conditions
Hidradenitis Suppurativa
Interventions
Imsidolimab
Placebo
Countries
United States
Canada
Georgia
Poland
Protocol Section
Identification Module
NCT ID
NCT04856930
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ANB019-208
Secondary IDs
ID
Type
Description
Link
2021-001440-99
EudraCT Number
Brief Title
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Hidradenitis Suppurativa
Official Title
A Phase 2, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With Hidradenitis Suppurativa
Acronym
Not provided
Organization
Vanda PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
Apr 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
Jul 7, 2021Actual
Primary Completion Date
Jul 15, 2022Actual
Completion Date
Dec 14, 2022Actual
First Submitted Date
Apr 20, 2021
First Submission Date that Met QC Criteria
Apr 20, 2021
First Posted Date
Apr 23, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Apr 29, 2025
Results First Submitted that Met QC Criteria
Sep 2, 2025
Results First Posted Date
Sep 22, 2025Actual
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
Sep 2, 2025
Last Update Posted Date
Sep 22, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Vanda PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
Efficacy and safety of imsidolimab (ANB019) in participants with Hidradenitis Suppurativa
Detailed Description
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab in adult participants with hidradenitis suppurativa (HS). This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with HS.
Conditions Module
Conditions
Hidradenitis Suppurativa
Keywords
IL-36 receptor
Interleukin 36
Imsidolimab
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
149Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Imsidolimab 400/200 milligrams (mg)
Experimental
400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks by subcutaneous (SC) injection up to 48 weeks
Biological: Imsidolimab
Imsidolimab 200/100 mg
Experimental
400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks by subcutaneous (SC) injection up to 48 weeks
Biological: Imsidolimab
Placebo
Placebo Comparator
Placebo-controlled period: Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection. The placebo-controlled period ended at Day 113 (Week 16).
Extension period: Participants received imsidolimab at the same dose as placebo-controlled period, SC every 4 weeks (Days 113, 141, 169, and 197).
After discontinuation from treatment, participants remained in the study for safety follow-up period of 8 weeks.
Biological: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Imsidolimab
Biological
Humanized Monoclonal Antibody
Imsidolimab 200/100 mg
Imsidolimab 400/200 milligrams (mg)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in AN Count at Week 16: Placebo-Controlled Period
The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations.
Baseline, Week 16
Secondary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in AN Count at Week 16: Placebo-Controlled Period
The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations.
Baseline, Week 16
Number of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50): Placebo-Controlled Period
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Clinically confirmed diagnosis of active HS with a disease duration of greater than or equal to (≥) 6 months before Day 1.
HS lesions present in at least 2 distinct anatomical areas.
Total Abscess and inflammatory nodule (AN) count ≥ 5.
Draining fistulas less than or equal to (≤) 20.
Stable HS for at least 6 weeks prior to Day 1 visit.
Exclusion Criteria:
1. Concomitant dermatological or medical conditions that may interfere with the Investigators' ability to evaluate the participant's response to therapy.
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
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Site 10-108
Birmingham
Alabama
35224
United States
Site 10-104
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
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
227 participants were screened for eligibility and 149 participants were randomized into the study.
Recruitment Details
Participants who had a clinically confirmed diagnosis of hidradenitis suppurativa (HS) with a disease duration of at least 6 months before Day 1, were enrolled in the study. Randomization was stratified based on Hurley Stage at Baseline (Stage II or III).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Imsidolimab 400/200 mg
Placebo-controlled period: Participants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous (SC) injection. The placebo-controlled period ended at Day 113 (Week 16).
Extension period: Participants received imsidolimab at the same dose as placebo-controlled period, SC every 4 weeks (Days 113, 141, 169, and 197).
After discontinuation from treatment, participants remained in the study for safety follow-up period of 8 weeks.
The number of participants with at least a 50% decrease from Baseline AN count, and no increase in abscesses or draining fistulas in comparison to baseline (HiSCR50) at Week 16 was calculated for each treatment group as follows:
A responder HiSCR50 was defined as a participant with
at least a 50% decrease in AN count from Baseline, and
no increase in abscess count relative to Baseline, and
no increase in draining fistula count relative to Baseline
Week 16
Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period
Participants were asked to assign a numerical score representing the HS worst pain intensity over the last 24 hours on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms).
Baseline, Week 16
Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period
Participants were asked to assign a numerical score representing the average intensity over the last 7 days of their HS pain symptoms on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms).
Baseline, Week 16
Percent Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period
Participants were asked to assign a numerical score representing the HS worst pain intensity over the last 24 hours on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms). Only participants that had Baseline score of >0 could be included in the analysis of Percent Change from Baseline.
Baseline, Week 16
Percent Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period
Participants were asked to assign a numerical score representing the average intensity over the last 7 days of their HS pain symptoms on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms). Only participants that had Baseline score of >0 could be included in the analysis of Percent Change from Baseline.
Baseline, Week 16
Number of Participants With Treatment-emergent Adverse Events (TEAEs): Placebo-Controlled Period
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was considered treatment-emergent if the date of onset was during or after first dose of study treatment during placebo-controlled period, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment.
From first dose (placebo-controlled period) up to Week 16
Number of Participants With TEAEs: Extension and Follow-up Period
An AE was any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was considered treatment-emergent if the date of onset was during or after first dose of study treatment in extension period, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment.
Placebo-controlled period: Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection. The placebo-controlled period ended at Day 113 (Week 16).
Extension period: Participants received imsidolimab at the same dose as placebo-controlled period, SC every 4 weeks (Days 113, 141, 169, and 197).
After discontinuation from treatment, participants remained in the study for safety follow-up period of 8 weeks.
FG002
Placebo
Placebo-controlled period: Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection. The placebo-controlled period ended at Day 113 (Week 16).
Extension period: Participants received imsidolimab at the same dose as placebo-controlled period, SC every 4 weeks (Days 113, 141, 169, and 197).
After discontinuation from treatment, participants remained in the study for safety follow-up period of 8 weeks.
FG00050 subjects
FG00150 subjects
FG00249 subjects
COMPLETED
FG00041 subjects
FG00142 subjects
FG00243 subjects
NOT COMPLETED
FG0009 subjects
FG0018 subjects
FG0026 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0006 subjects
FG0015 subjects
FG0024 subjects
Lost to Follow-up
FG0003 subjects
FG0011 subjects
FG0020 subjects
Pregnancy
FG0000 subjects
FG0011 subjects
FG0020 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
Use of Any Prohibited Medication or Treatment
FG0000 subjects
FG0011 subjects
FG0020 subjects
Extension Period (16 Weeks)
Type
Comment
Milestone Data
STARTED
FG00041 subjects
FG00142 subjects
FG00243 subjects
COMPLETED
FG00028 subjects
FG00132 subjects
FG00235 subjects
NOT COMPLETED
FG00013 subjects
FG00110 subjects
FG0028 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0009 subjects
FG0015 subjects
FG0021 subjects
Lost to Follow-up
FG000
Follow-up Period (8 Weeks)
Type
Comment
Milestone Data
STARTED
FG00028 subjects
FG00132 subjects
FG00235 subjects
COMPLETED
FG00013 subjects
FG00118 subjects
FG00213 subjects
NOT COMPLETED
FG00015 subjects
FG00114 subjects
FG00222 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0003 subjects
FG0012 subjects
FG0023 subjects
Lost to Follow-up
FG000
Intent to Treat (IIT) Analysis Set included all the randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Imsidolimab 400/200 mg
Placebo-controlled period: Participants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous (SC) injection. The placebo-controlled period ended at Day 113 (Week 16).
Extension period: Participants received imsidolimab at the same dose as placebo-controlled period, SC every 4 weeks (Days 113, 141, 169, and 197).
After discontinuation from treatment, participants remained in the study for safety follow-up period of 8 weeks.
BG001
Imsidolimab 200/100 mg
Placebo-controlled period: Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection. The placebo-controlled period ended at Day 113 (Week 16).
Extension period: Participants received imsidolimab at the same dose as placebo-controlled period, SC every 4 weeks (Days 113, 141, 169, and 197).
After discontinuation from treatment, participants remained in the study for safety follow-up period of 8 weeks.
BG002
Placebo
Placebo-controlled period: Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection. The placebo-controlled period ended at Day 113 (Week 16).
Extension period: Participants received imsidolimab at the same dose as placebo-controlled period, SC every 4 weeks (Days 113, 141, 169, and 197).
After discontinuation from treatment, participants remained in the study for safety follow-up period of 8 weeks.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00050
BG00150
BG00249
BG003149
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
ParticipantsBG00050
ParticipantsBG00150
ParticipantsBG00249
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG00050
ParticipantsBG00150
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00050
ParticipantsBG00150
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00050
ParticipantsBG00150
ParticipantsBG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Canada
ParticipantsBG00050
ParticipantsBG00150
ParticipantsBG002
Abscess and Inflammatory Nodule (AN) Count
The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations.
Mean
Standard Deviation
count of abscess and inflammatory nodule
Title
Denominators
Categories
ParticipantsBG00050
ParticipantsBG00150
ParticipantsBG002
Worst Pain Numeric Rating Scale (NRS) Score
Participants were asked to assign a numerical score representing the HS worst pain intensity over the last 24 hours on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms).
ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG00049
ParticipantsBG001
Average pain NRS Score
Participants were asked to assign a numerical score representing the average intensity over the last 7 days of their HS pain symptoms on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms).
ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG00049
ParticipantsBG001
Hurley Stage
The Hurley system describes 3 clinical stages of HS (Stage I, II, and II). Stage I - abscess formation, single or multiple, without sinus tracts and cicatrization; Stage II - single or multiple, widely separated, recurrent abscesses with tract formation and cicatrization; Stage III - diffuse or near-diffuse involvement, or multiple interconnected tracts and abscesses across the entire area. Number of participants with Hurley Stage II and III was planned to be reported.
Count of Participants
Participants
Title
Denominators
Categories
Hurley Stage Il
ParticipantsBG00050
ParticipantsBG00150
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
Change From Baseline in AN Count at Week 16: Placebo-Controlled Period
The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations.
ITT Analysis Set with available data was analyzed.
Posted
Mean
Standard Deviation
count of abscess and inflammatory nodule
Baseline, Week 16
ID
Title
Description
OG000
Placebo-Controlled Period: Imsidolimab 400/200 mg
Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
OG001
Placebo-Controlled Period: Imsidolimab 200/100 mg
Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
OG002
Placebo-Controlled Period: Placebo
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection.
Units
Counts
Participants
OG00039
OG00141
OG00242
Title
Denominators
Categories
Title
Measurements
OG000-5.9± 6.05
OG001-4.1± 4.63
OG002-5.6± 7.40
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
OG002
Linear repeated measures model (LRMM)
0.7841
LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.
Least Square (LS) Mean Difference
-0.3
Standard Error of the Mean
1.25
2-Sided
90
-2.42
1.73
Superiority
Secondary
Percent Change From Baseline in AN Count at Week 16: Placebo-Controlled Period
The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations.
ITT Analysis Set with available data was analyzed.
Posted
Mean
Standard Deviation
percent change
Baseline, Week 16
ID
Title
Description
OG000
Placebo-Controlled Period: Imsidolimab 400/200 mg
Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
OG001
Placebo-Controlled Period: Imsidolimab 200/100 mg
Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
OG002
Placebo-Controlled Period: Placebo
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection.
Units
Secondary
Number of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50): Placebo-Controlled Period
The number of participants with at least a 50% decrease from Baseline AN count, and no increase in abscesses or draining fistulas in comparison to baseline (HiSCR50) at Week 16 was calculated for each treatment group as follows:
A responder HiSCR50 was defined as a participant with
at least a 50% decrease in AN count from Baseline, and
no increase in abscess count relative to Baseline, and
no increase in draining fistula count relative to Baseline
ITT Analysis Set with available data was analyzed.
Posted
Count of Participants
Participants
Week 16
ID
Title
Description
OG000
Placebo-Controlled Period: Imsidolimab 400/200 mg
Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
OG001
Placebo-Controlled Period: Imsidolimab 200/100 mg
Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
OG002
Placebo-Controlled Period: Placebo
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection.
Secondary
Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period
Participants were asked to assign a numerical score representing the HS worst pain intensity over the last 24 hours on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms).
ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo-Controlled Period: Imsidolimab 400/200 mg
Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
OG001
Placebo-Controlled Period: Imsidolimab 200/100 mg
Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
OG002
Placebo-Controlled Period: Placebo
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection.
Secondary
Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period
Participants were asked to assign a numerical score representing the average intensity over the last 7 days of their HS pain symptoms on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms).
ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo-Controlled Period: Imsidolimab 400/200 mg
Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
OG001
Placebo-Controlled Period: Imsidolimab 200/100 mg
Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
OG002
Placebo-Controlled Period: Placebo
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection.
Secondary
Percent Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period
Participants were asked to assign a numerical score representing the HS worst pain intensity over the last 24 hours on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms). Only participants that had Baseline score of >0 could be included in the analysis of Percent Change from Baseline.
ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline. "Overall number of participants analyzed" included only those participants with Baseline score of >0.
Posted
Mean
Standard Deviation
percent change
Baseline, Week 16
ID
Title
Description
OG000
Placebo-Controlled Period: Imsidolimab 400/200 mg
Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
OG001
Placebo-Controlled Period: Imsidolimab 200/100 mg
Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
OG002
Placebo-Controlled Period: Placebo
Secondary
Percent Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period
Participants were asked to assign a numerical score representing the average intensity over the last 7 days of their HS pain symptoms on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms). Only participants that had Baseline score of >0 could be included in the analysis of Percent Change from Baseline.
ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline. "Overall number of participants analyzed" included only those participants with Baseline score of >0.
Posted
Mean
Standard Deviation
percent change
Baseline, Week 16
ID
Title
Description
OG000
Placebo-Controlled Period: Imsidolimab 400/200 mg
Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
OG001
Placebo-Controlled Period: Imsidolimab 200/100 mg
Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
OG002
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs): Placebo-Controlled Period
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was considered treatment-emergent if the date of onset was during or after first dose of study treatment during placebo-controlled period, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment.
Safety analysis set included all randomized participants who received at least 1 dose of imsidolimab or placebo.
Posted
Count of Participants
Participants
From first dose (placebo-controlled period) up to Week 16
ID
Title
Description
OG000
Placebo-Controlled Period: Imsidolimab 400/200 mg
Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
OG001
Placebo-Controlled Period: Imsidolimab 200/100 mg
Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
OG002
Placebo-Controlled Period: Placebo
Secondary
Number of Participants With TEAEs: Extension and Follow-up Period
An AE was any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was considered treatment-emergent if the date of onset was during or after first dose of study treatment in extension period, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment.
Extension Analysis Set included subset of the safety analysis set who received at least 1 dose of imsidolimab in the extension period.
Posted
Count of Participants
Participants
From first dose (extension period) up to Week 40
ID
Title
Description
OG000
Extension Period: Imsidolimab 400/200 mg
Participants received a dose of 400 mg of imsidolimab on Day 113, followed by a 200-mg dose on Days 141, 169, and 197 by SC injection.
OG001
Extension Period: Imsidolimab 200/100 mg
Participants received a dose of 200 mg of imsidolimab on Day 113, followed by a 100-mg dose on Days 141, 169, and 197 by SC injection.
OG002
Extension Period: Placebo to Imsidolimab 400/200 mg
Participants who received placebo in placebo-controlled period, received 400 mg of imsidolimab on Day 113, followed by a dose of 200 mg on Days 141, 169, and 197 by SC injection in extension period.
Time Frame
From first dose up to Week 40
Description
Placebo-Controlled Period: Safety Analysis Set
Extension Period: Extension Analysis Set
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-Controlled Period: Imsidolimab 400/200 mg
Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
0
50
0
50
5
50
EG001
Placebo-Controlled Period: Imsidolimab 200/100 mg
Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
0
50
2
50
6
50
EG002
Placebo-Controlled Period: Placebo
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection.
0
49
3
49
9
49
EG003
Extension Period: Imsidolimab 400/200 mg
Participants received a dose of 400 mg of imsidolimab on Day 113, followed by a dose of 200 mg on Days 141, 169, and 197 by SC injection.
0
40
0
40
9
40
EG004
Extension Period: Imsidolimab 200/100 mg
Participants received a dose of 200 mg of imsidolimab on Day 113, followed by a dose of 100 mg on Days 141, 169, and 197 by SC injection.
0
42
1
42
10
42
EG005
Extension Period: Placebo to Imsidolimab 400/200 mg
Participants who received placebo in placebo-controlled period, received 400 mg of imsidolimab on Day 113, followed by a dose of 200 mg on Days 141, 169, and 197 by SC injection in extension period.
0
19
0
19
9
19
EG006
Extension Period: Placebo to Imsidolimab 200/100 mg
Participants who received placebo in placebo-controlled period, received 200 mg of imsidolimab on Day 113, followed by a dose of 100 mg on Days 141, 169, and 197 by SC injection in extension period.
LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.
LS Mean Difference
1.3
Standard Error of the Mean
1.25
2-Sided
90
-0.74
3.40
Superiority
Counts
Participants
OG00039
OG00141
OG00242
Title
Denominators
Categories
Title
Measurements
OG000-44.7± 39.23
OG001-36.7± 36.59
OG002-41.2± 43.69
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
OG002
LRMM
0.5939
LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.
LS Mean Difference
-4.8
Standard Error of the Mean
8.97
2-Sided
90
-19.66
10.07
Superiority
OG001
OG002
LRMM
0.7002
LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.
LS Mean Difference
3.5
Standard Error of the Mean
8.95
2-Sided
90
-11.38
18.29
Superiority
Units
Counts
Participants
OG00039
OG00141
OG00242
Title
Denominators
Categories
Title
Measurements
OG00016
OG00116
OG00215
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
OG002
Risk Difference (RD)
5.3
2-Sided
90
-13.3
23.4
Estimate parameter and 90% CI was based on Unadjusted Risk Difference and exact unconditional confidence intervals (CI).
Superiority
OG001
OG002
Risk Difference (RD)
3.3
2-Sided
90
-14.6
21.0
Estimate parameter and 90% C was based on Unadjusted Risk Difference and exact unconditional CIs.
Superiority
Units
Counts
Participants
OG00039
OG00140
OG00242
Title
Denominators
Categories
Title
Measurements
OG000-0.3± 2.89
OG001-0.7± 2.37
OG002-0.4± 3.22
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
OG002
LRMM
0.7282
LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.
LS Mean Difference
-0.2
Standard Error of the Mean
0.54
2-Sided
90
-1.08
0.70
Superiority
OG001
OG002
LRMM
0.5019
LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.
LS Mean Difference
-0.4
Standard Error of the Mean
0.54
2-Sided
90
-1.25
0.53
Superiority
Units
Counts
Participants
OG00039
OG00141
OG00242
Title
Denominators
Categories
Title
Measurements
OG000-0.5± 2.29
OG001-1.0± 2.48
OG002-0.5± 2.74
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
OG002
LRMM
0.7698
LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.
LS Mean Difference
-0.1
Standard Error of the Mean
0.49
2-Sided
90
-0.96
0.67
Superiority
OG001
OG002
LRMM
0.7468
LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.
LS Mean Difference
-0.2
Standard Error of the Mean
0.49
2-Sided
90
-0.97
0.65
Superiority
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection.
Units
Counts
Participants
OG00037
OG00138
OG00240
Title
Denominators
Categories
Title
Measurements
OG0007.6± 81.81
OG00110.2± 146.92
OG00230.3± 136.89
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
OG002
LRMM
0.2750
LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.
LS Mean Difference
-25.7
Standard Error of the Mean
23.46
2-Sided
90
-64.57
13.14
Superiority
OG001
OG002
LRMM
0.3757
LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.
LS Mean Difference
-21.2
Standard Error of the Mean
23.81
2-Sided
90
-60.60
18.28
Superiority
Placebo-Controlled Period: Placebo
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection.
Units
Counts
Participants
OG00037
OG00139
OG00241
Title
Denominators
Categories
Title
Measurements
OG000-1.3± 58.54
OG001-18.3± 37.76
OG0024.5± 77.25
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
OG002
LRMM
0.6146
LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.
LS Mean Difference
-6.6
Standard Error of the Mean
13.04
2-Sided
90
-28.22
15.05
Superiority
OG001
OG002
LRMM
0.4951
LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.
LS Mean Difference
-8.9
Standard Error of the Mean
12.95
2-Sided
90
-30.35
12.62
Superiority
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection.
Units
Counts
Participants
OG00050
OG00150
OG00249
Title
Denominators
Categories
Title
Measurements
OG00019
OG00114
OG00218
OG003
Extension Period: Placebo to Imsidolimab 200/100 mg
Participants who received placebo in placebo-controlled period, received 200 mg of imsidolimab on Day 113, followed by a dose of 100 mg on Days 141, 169, and 197 by SC injection in extension period.