A Study to Evaluate the Efficacy and Safety of Bimekizuma... | NCT04242446 | Trialant
NCT04242446
Sponsor
UCB Biopharma SRL
Status
Completed
Last Update Posted
May 19, 2026Actual
Enrollment
505Actual
Phase
Phase 3
Conditions
Hidradenitis Suppurativa
Interventions
Bimekizumab
Placebo
Countries
United States
Australia
Belgium
Canada
Denmark
France
Germany
Greece
Israel
Italy
Netherlands
Norway
Spain
Switzerland
Turkey (Türkiye)
Protocol Section
Identification Module
NCT ID
NCT04242446
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
HS0003
Secondary IDs
ID
Type
Description
Link
2019-002550-23
EudraCT Number
Brief Title
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
Acronym
BE HEARD I
Organization
UCB PharmaINDUSTRY
Status Module
Record Verification Date
May 2026
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
Feb 19, 2020Actual
Primary Completion Date
Apr 7, 2022Actual
Completion Date
Feb 19, 2023Actual
First Submitted Date
Jan 23, 2020
First Submission Date that Met QC Criteria
Jan 23, 2020
First Posted Date
Jan 27, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Dec 18, 2024
Results First Submitted that Met QC Criteria
Dec 18, 2024
Results First Posted Date
Jan 9, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 6, 2023
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Apr 7, 2023Actual
Last Update Submitted Date
May 4, 2026
Last Update Posted Date
May 19, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
UCB Biopharma SRLINDUSTRY
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
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)
Detailed Description
Not provided
Conditions Module
Conditions
Hidradenitis Suppurativa
Keywords
Bimekizumab
UCB4940
HS
Hidradenitis Suppurativa
Acne inversa
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
505Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Bimekizumab dosing regimen 1
Experimental
Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the Treatment Period.
Drug: Bimekizumab
Bimekizumab dosing regimen 2
Experimental
Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the Treatment Period.
Drug: Bimekizumab
Bimekizumab dosing regimen 3
Experimental
Subjects participating in the study will receive assigned bimekizumab dosing regimen 3 during the Treatment Period.
Drug: Bimekizumab
Placebo Group
Placebo Comparator
Subjects randomized to this arm will receive placebo during the Initial Treatment Period and bimekizumab during the Maintenance Treatment Period.
Drug: Bimekizumab
Other: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Bimekizumab
Drug
Subjects will receive bimekizumab at pre-specified time-points.
Bimekizumab dosing regimen 1
Bimekizumab dosing regimen 2
Bimekizumab dosing regimen 3
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16
HiSCR50 was defined as at least a 50 percent (%) reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count. Intermittent missing data are imputed using multiple imputation with Markov Chain Monte Carlo (MCMC) method followed by monotone regression for monotone missing data. Lesion counts were imputed and then dichotomized to obtain the response status. Participants who experienced an intercurrent event were treated as nonresponders following the intercurrent event. An intercurrent event was defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to an adverse event (AE) or lack of efficacy. Percentage of participants shown do not account for model effects using the logistic regression model.
Week 16
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16
HiSCR75 was defined as at least a 75% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining tunnel count. Intermittent missing data were imputed using multiple imputation with MCMC method followed by monotone regression for monotone missing data. Lesion counts were imputed and then dichotomized to obtain the response status. Participants who experienced an intercurrent event were treated as nonresponders following the intercurrent event. An intercurrent event was defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to an AE or lack of efficacy. Percentage of participants shown do not account for model effects using the logistic regression model.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participant must be at least 18 years of age, at the time of signing the informed consent. If a study participant is under the local age of consent and is at least 18 years of age, written informed consent will be obtained from both the study participant and the legal representative
Study participants must have a diagnosis of Hidradenitis Suppurativa (HS) based on clinical history and physical examination for at least 6 months prior to the Baseline visit
Study participant must have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla), 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline visits
Study participant must have moderate to severe HS defined as a total of ≥5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline visits
Study participant must have had an inadequate response to a course of a systemic antibiotic for treatment of HS as assessed by the Investigator through study participant interview and review of medical history
A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Not a woman of childbearing potential (WOCBP) OR
A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 20 weeks after the last dose of investigational medicinal product (IMP)
Exclusion Criteria:
Draining tunnel count of >20 at the Baseline Visit
Any other active skin disease or condition (eg, bacterial cellulitis, candida intertrigo, extensive condyloma) that may, in the opinion of the Investigator, interfere with the assessment of hidradenitis suppurativa (HS)
Study participant has a diagnosis of sarcoidosis, systemic lupus erythematosus, or active inflammatory bowel disease (IBD)
Primary immunosuppressive condition, including taking immunosuppressive therapy following an organ transplant, or has had a splenectomy
Female who is breastfeeding, pregnant, or plans to become pregnant during the study or within 20 weeks following the final dose of investigational medicinal product (IMP)
Active infection or history of certain infection(s)
Active tuberculosis (TB) infection, latent TB infection, high risk of exposure to TB infection, current or history of nontuberculous mycobacterium (NTM) infection
Concurrent malignancy. Study participants with a history of malignancy within the past 5 years prior to the Screening Visit are excluded, EXCEPT if the malignancy was a cutaneous squamous or basal cell carcinoma, or in situ cervical cancer that has been treated and is considered cured
History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease
Known hypersensitivity to any components of bimekizumab or comparative drugs as stated in this protocol
Concomitant and prior medication restrictions
Myocardial infarction or stroke within the 6 months prior to the Screening Visit
Study participant has the presence of active suicidal ideation, or positive suicide behavior using the "Screening" version of the electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
Presence of moderately severe major depression or severe major depression
Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
Kirby JS, Thorlacius L, Lambert J, Ciaravino V, Rolleri R, Pansar I, Muller E, Pelligra CG, Ingram JR. Psychometric validation and interpretation thresholds of the Hidradenitis Suppurativa Quality of Life (HiSQOL(c)) questionnaire using pooled data from the phase III BE HEARD I & II trials of bimekizumab in hidradenitis suppurativa. Br J Dermatol. 2025 Jun 20;193(1):93-104. doi: 10.1093/bjd/ljaf067.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Access Criteria
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Subjects will receive placebo at pre-specified time-points during the Initial Treatment Period.
Placebo Group
PBO
Week 16
Absolute Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
The DLQI is a patient-reported questionnaire designed for use in adult participants with skin diseases and Hidradenitis Suppurativa (HS). The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients' health related quality of life (HRQoL), with a recall period of 7 days. This instrument asks participants 10 questions about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The scoring of each answer for the DLQI is on a scale range of 0 (not at all) to 3 (very much). The DLQI total score was calculated by adding the score of each question. The maximum score is 30, and the minimum score is 0. The higher the score, the more quality of life is impaired. Participants who experienced an intercurrent event were treated as missing following the intercurrent event and imputed using the multiple imputation method for missing data.
Baseline, Week 16
Absolute Change From Baseline in Worst Skin Pain Score at Week 16
Absolute change from Baseline in Worst Skin Pain score at Week 16 was assessed using the worst skin pain item in the Hidradenitis Suppurativa Symptom Daily Diary (HSSDD). Worst skin pain during the past 24 hours was assessed daily using an 11-point numeric rating scale (NRS) which ranges from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The worst skin pain score was derived from the weekly average of daily scores, defined as the sum of the scored item over the course of the study week divided by the number of days in which the item was completed, relative to each respective visit date. Intermittent missing data are imputed using multiple imputation with MCMC method followed by monotone regression for monotone missing data. Participants who experienced an intercurrent event were treated as missing following the intercurrent event and imputed using the multiple imputation method for missing data. Mean values shown do not account for model effects using the ANCOVA model.
Baseline, Week 16
Percentage of Participants Achieving Worst Skin Pain Response at Week 16
Skin pain response at Week 16, as assessed by "worst skin pain" item in HSSDD, was defined as an improvement in weekly worst skin pain score of at least 3 points versus Baseline. Worst skin pain during the past 24 hours was assessed daily using an 11-point numeric rating scale (NRS) which ranges from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Worst skin pain score was derived from weekly average of daily scores (sum of scored item over study week/number of days in which item completed, relative to each respective visit). Intermittent missing data were imputed using multiple imputation with MCMC method followed by monotone regression for monotone missing data. Weekly pain scores were imputed and then dichotomized to obtain response status. Participants who experienced an intercurrent event were treated as non-responders following the intercurrent event. Percentage of participants shown do not account for model effects using logistic regression model.
Week 16
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up [SFU] period).
From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Percentage of Participants With Serious Treatment-emergent Adverse Events During the Study
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death; Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent disability/incapacity; Is a congenital anomaly/birth defect; Important medical events. TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period).
From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From the Study
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs leading to discontinuation of the study are reported.
From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Tzellos T, Giamarellos-Bourboulis EJ, van Straalen KR, Martorell A, Kirby B, Alavi A, Hayama K, Khattri S, Gulliver W, Sayed CJ, Davis L, Rolleri RL, Crater C, Pansar I, Lambert J, Zouboulis CC. Bimekizumab efficacy using IHS4 outcomes in hidradenitis suppurativa: Results from BE HEARD I and II. J Eur Acad Dermatol Venereol. 2026 Feb 14. doi: 10.1111/jdv.70356. Online ahead of print.
Sayed CJ, Kirby B, Garg A, Naik HB, Kimball AB, Zouboulis CC, Jemec GBE, Kokolakis G, Ingram JR, Morita A, Deherder D, Crater C, Rolleri RL, Vaux T, Lambert J, Lukowski B, Bechara FG. Bimekizumab demonstrated a favorable safety profile and high levels of efficacy with up to 2 years of treatment in patients with moderate to severe hidradenitis suppurativa: Pooled results from two phase 3 randomized, controlled trials and their open-label extension. J Am Acad Dermatol. 2026 Mar;94(3):867-878. doi: 10.1016/j.jaad.2025.11.031. Epub 2025 Nov 15.
Daveluy S, Gottlieb AB, Augustin M, Lev-Tov H, Szepietowski JC, Horvath B, Porter ML, Hayama K, Lambert J, Tilt N, Lukowski B, Thorlacius L. Association Between Bimekizumab's Clinical Response and Patient-Reported Benefits on Health-Related Quality of Life: Results from BE HEARD I and II. Dermatol Ther (Heidelb). 2026 Jul;16(7):3315-3329. doi: 10.1007/s13555-026-01790-2. Epub 2026 Jun 5.
Kimball AB, Jemec GBE, Sayed CJ, Kirby JS, Prens E, Ingram JR, Garg A, Gottlieb AB, Szepietowski JC, Bechara FG, Giamarellos-Bourboulis EJ, Fujita H, Rolleri R, Joshi P, Dokhe P, Muller E, Peterson L, Madden C, Bari M, Zouboulis CC. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48-week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials. Lancet. 2024 Jun 8;403(10443):2504-2519. doi: 10.1016/S0140-6736(24)00101-6. Epub 2024 May 22.
FG002
BKZ Dosing Regimen 2
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
FG003
Placebo/BKZ Dosing Regimen 2
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
FG004
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
FG005
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
FG006
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
FG00072 subjects
FG001144 subjects
FG002289 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG00065 subjects
FG001127 subjects
FG002259 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0007 subjects
FG00117 subjects
FG00230 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0015 subjects
FG0027 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Protocol Violation
FG0000 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0013 subjects
FG0022 subjects
FG0030 subjects
FG004
Consent withdrawn by subject, not due to AE
FG0004 subjects
FG0016 subjects
FG00214 subjects
FG0030 subjects
Country Relocation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawn based to Exclusion Criterion
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Per Sponsors Request Due To Covid 19 Pandemic
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Randomized, not treated
FG0000 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
FG004
Maintenance Treatment Period: Week 16-48
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00365 subjects
FG004125 subjects2 participants completed the 16-Week Initial Treatment Period but did not enter the Maintenance Treatment Period because of the below reason: Adverse event and Consent withdrawn by subject (not due to adverse event).
FG005129 subjects1 participant completed the 16-Week Initial Treatment Period but did not enter the Maintenance Treatment Period because of the below reason: Protocol violation.
FG006129 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00344 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00321 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline characteristics refer to the RS which consisted of all participants randomized into the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received placebo during the 16-weeks Initial Treatment Period.
BG001
BKZ Dosing Regimen 1
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
BG002
BKZ Dosing Regimen 2
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00072
BG001144
BG002289
BG003505
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
Title
Measurements
BG00036.4± 12.4
BG00136.3± 11.2
BG00236.9± 12.4
BG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
18 years - <65 years
BG00071
BG001143
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00044
BG00198
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaskan Native
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG00113
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16
HiSCR50 was defined as at least a 50 percent (%) reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count. Intermittent missing data are imputed using multiple imputation with Markov Chain Monte Carlo (MCMC) method followed by monotone regression for monotone missing data. Lesion counts were imputed and then dichotomized to obtain the response status. Participants who experienced an intercurrent event were treated as nonresponders following the intercurrent event. An intercurrent event was defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to an adverse event (AE) or lack of efficacy. Percentage of participants shown do not account for model effects using the logistic regression model.
The RS consisted of all participants randomized into the study.
Posted
Number
95% Confidence Interval
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo during the 16-weeks Initial Treatment Period.
OG001
BKZ Dosing Regimen 1
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
OG002
BKZ Dosing Regimen 2
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
Units
Counts
Participants
OG00072
OG001144
OG002289
Title
Denominators
Categories
Title
Measurements
OG00028.7(18.1 to 39.3)
OG00145.3(36.8 to 53.8)
OG00247.8(41.8 to 53.7)
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
Regression, Logistic
0.030
Odds Ratio (OR)
2.000
2-Sided
97.5
0.979
4.089
Superiority
OG000
OG002
Regression, Logistic
0.006
Secondary
Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16
HiSCR75 was defined as at least a 75% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining tunnel count. Intermittent missing data were imputed using multiple imputation with MCMC method followed by monotone regression for monotone missing data. Lesion counts were imputed and then dichotomized to obtain the response status. Participants who experienced an intercurrent event were treated as nonresponders following the intercurrent event. An intercurrent event was defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to an AE or lack of efficacy. Percentage of participants shown do not account for model effects using the logistic regression model.
The RS consisted of all participants randomized into the study.
Posted
Number
95% Confidence Interval
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo during the 16-weeks Initial Treatment Period.
OG001
BKZ Dosing Regimen 1
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
OG002
BKZ Dosing Regimen 2
Secondary
Absolute Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
The DLQI is a patient-reported questionnaire designed for use in adult participants with skin diseases and Hidradenitis Suppurativa (HS). The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients' health related quality of life (HRQoL), with a recall period of 7 days. This instrument asks participants 10 questions about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The scoring of each answer for the DLQI is on a scale range of 0 (not at all) to 3 (very much). The DLQI total score was calculated by adding the score of each question. The maximum score is 30, and the minimum score is 0. The higher the score, the more quality of life is impaired. Participants who experienced an intercurrent event were treated as missing following the intercurrent event and imputed using the multiple imputation method for missing data.
The RS consisted of all study participants randomized into the study. Mean values shown do not account for model effects using the analysis of covariance (ANCOVA) model. Intercurrent event defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to AE or lack of efficacy.
Posted
Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo during the 16-weeks Initial Treatment Period.
OG001
BKZ Dosing Regimen 1
Secondary
Absolute Change From Baseline in Worst Skin Pain Score at Week 16
Absolute change from Baseline in Worst Skin Pain score at Week 16 was assessed using the worst skin pain item in the Hidradenitis Suppurativa Symptom Daily Diary (HSSDD). Worst skin pain during the past 24 hours was assessed daily using an 11-point numeric rating scale (NRS) which ranges from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The worst skin pain score was derived from the weekly average of daily scores, defined as the sum of the scored item over the course of the study week divided by the number of days in which the item was completed, relative to each respective visit date. Intermittent missing data are imputed using multiple imputation with MCMC method followed by monotone regression for monotone missing data. Participants who experienced an intercurrent event were treated as missing following the intercurrent event and imputed using the multiple imputation method for missing data. Mean values shown do not account for model effects using the ANCOVA model.
The RS consisted of all study participants randomized into the study. Intercurrent event defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to AE or lack of efficacy.
Posted
Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo during the 16-weeks Initial Treatment Period.
OG001
BKZ Dosing Regimen 1
Secondary
Percentage of Participants Achieving Worst Skin Pain Response at Week 16
Skin pain response at Week 16, as assessed by "worst skin pain" item in HSSDD, was defined as an improvement in weekly worst skin pain score of at least 3 points versus Baseline. Worst skin pain during the past 24 hours was assessed daily using an 11-point numeric rating scale (NRS) which ranges from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Worst skin pain score was derived from weekly average of daily scores (sum of scored item over study week/number of days in which item completed, relative to each respective visit). Intermittent missing data were imputed using multiple imputation with MCMC method followed by monotone regression for monotone missing data. Weekly pain scores were imputed and then dichotomized to obtain response status. Participants who experienced an intercurrent event were treated as non-responders following the intercurrent event. Percentage of participants shown do not account for model effects using logistic regression model.
The RS consisted of all study participants randomized into the study. Here, number of participants analyzed included RS with HSSDD worst skin pain score >=3 at Baseline. Intercurrent event defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to AE or lack of efficacy.
Posted
Number
95% Confidence Interval
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo during the 16-weeks Initial Treatment Period.
OG001
Secondary
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up [SFU] period).
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. The MS consisted of all study participants who received at least 1 dose (full or partial) of BKZ in the Maintenance Treatment Period.
Posted
Number
percentage of participants
From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
ID
Title
Description
OG000
Placebo
Participants received placebo during the 16-weeks Initial Treatment Period.
OG001
BKZ Dosing Regimen 1
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
OG002
Secondary
Percentage of Participants With Serious Treatment-emergent Adverse Events During the Study
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death; Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent disability/incapacity; Is a congenital anomaly/birth defect; Important medical events. TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period).
The SS consisted of all study participants who received at least 1 dose (full or partial) of IMP. The MS consisted of all study participants who received at least 1 dose (full or partial) of BKZ in the Maintenance Treatment Period.
Posted
Number
percentage of participants
From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
ID
Title
Description
OG000
Placebo
Participants received placebo during the 16-weeks Initial Treatment Period.
OG001
BKZ Dosing Regimen 1
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
OG002
BKZ Dosing Regimen 2
Secondary
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From the Study
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs leading to discontinuation of the study are reported.
The SS consisted of all study participants who received at least 1 dose (full or partial) of IMP. The MS consisted of all study participants who received at least 1 dose (full or partial) of BKZ in the Maintenance Treatment Period.
Posted
Number
percentage of participants
From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
ID
Title
Description
OG000
Placebo
Participants received placebo during the 16-weeks Initial Treatment Period.
OG001
BKZ Dosing Regimen 1
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
OG002
Time Frame
From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Description
TEAEs are defined as AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
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
Participants received placebo during the 16-weeks Initial Treatment Period.
0
72
0
72
23
72
EG001
BKZ Dosing Regimen 1
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
0
143
4
143
52
143
EG002
BKZ Dosing Regimen 2
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
0
286
6
286
94
286
EG003
Placebo/BKZ Dosing Regimen 2
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
0
65
6
65
38
65
EG004
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
0
125
10
125
63
125
EG005
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
0
129
7
129
69
129
EG006
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
1
129
10
129
63
129
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac failure acute
Cardiac disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0021 events1 affected286 at risk
EG0030 events0 affected65 at risk
EG0040 events0 affected125 at risk
EG0050 events0 affected129 at risk
EG0060 events0 affected129 at risk
Keratitis
Eye disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0011 events1 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0011 events1 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0021 events1 affected286 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0021 events1 affected286 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0021 events1 affected286 at risk
EG003
Pregnancy on contraceptive
Pregnancy, puerperium and perinatal conditions
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0021 events1 affected286 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0011 events1 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Hidradenitis
Skin and subcutaneous tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0021 events1 affected286 at risk
EG003
Abortion induced
Surgical and medical procedures
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0011 events1 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Peritonitis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Periorbital cellulitis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Genital candidiasis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Oropharyngeal candidiasis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Groin infection
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Sepsis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Wound infection staphylococcal
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected72 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected286 at risk
EG003
Intraductal proliferative breast lesion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Subject Withdrew Due To Custody Issue & Relocation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
Relocation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
Patient Relocated And Withdrew Consent
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
Patient Move Away
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Patient Relocated Last Minute Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Needs Systemic Therapy Incompatible With Protocol
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Sponsor's Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Develop Illness Would Interfere With Participation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
36.7
± 12.0
283
BG003497
65 years - <85 years
BG0001
BG0011
BG0026
BG0038
176
BG003318
Male
BG00028
BG00146
BG002113
BG003187
2
BG0032
Asian
BG0003
BG0013
BG0022
BG0038
Black
BG0008
BG00121
BG00241
BG00370
Native Hawaiian or Other Pacific Islander
BG0000
BG0011
BG0020
BG0031
White
BG00055
BG001105
BG002233
BG003393
Other/mixed
BG0005
BG00113
BG00210
BG00328
Missing
BG0001
BG0011
BG0021
BG0033
20
BG00337
Not Hispanic or Latino
BG00067
BG001131
BG002268
BG003466
Missing
BG0001
BG0010
BG0021
BG0032
Odds Ratio (OR)
2.234
2-Sided
97.5
1.159
4.307
Superiority
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
Units
Counts
Participants
OG00072
OG001144
OG002289
Title
Denominators
Categories
Title
Measurements
OG00018.4(9.3 to 27.5)
OG00124.7(17.3 to 32.1)
OG00233.4(27.8 to 39.1)
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
Regression, Logistic
0.350
Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.
Odds Ratio (OR)
1.416
2-Sided
97.5
0.615
3.260
Superiority
OG000
OG002
Regression, Logistic
0.021
Odds Ratio (OR)
2.175
2-Sided
97.5
1.021
4.635
Superiority
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
OG002
BKZ Dosing Regimen 2
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
Units
Counts
Participants
OG00072
OG001144
OG002289
Title
Denominators
Categories
Title
Measurements
OG000-2.7± 0.9
OG001-5.5± 0.6
OG002-5.0± 0.4
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
ANCOVA
0.002
Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.
LS mean difference
-2.574
2-Sided
97.5
-4.472
-0.675
Superiority
OG000
OG002
ANCOVA
<0.001
LS mean difference
-2.682
2-Sided
97.5
-4.394
-0.970
Superiority
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
OG002
BKZ Dosing Regimen 2
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
Units
Counts
Participants
OG00072
OG001144
OG002289
Title
Denominators
Categories
Title
Measurements
OG000-0.99± 0.38
OG001-1.56± 0.26
OG002-2.00± 0.17
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
ANCOVA
0.201
Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.
LS mean difference
-0.551
2-Sided
97.5
-1.521
0.418
Superiority
OG000
OG002
ANCOVA
0.002
LS mean difference
-1.186
2-Sided
97.5
-2.050
-0.322
Superiority
BKZ Dosing Regimen 1
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
OG002
BKZ Dosing Regimen 2
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
Units
Counts
Participants
OG00046
OG001103
OG002190
Title
Denominators
Categories
Title
Measurements
OG00015.0(3.6 to 26.5)
OG00122.1(12.7 to 31.4)
OG00232.3(25.1 to 39.5)
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
Regression, Logistic
0.367
Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.
Odds Ratio (OR)
1.618
2-Sided
97.5
0.489
5.352
Superiority
OG000
OG002
Regression, Logistic
0.041
Odds Ratio (OR)
2.757
2-Sided
97.5
0.909
8.364
Superiority
BKZ Dosing Regimen 2
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
OG003
Placebo/BKZ Dosing Regimen 2
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
OG004
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
OG005
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
OG006
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
Units
Counts
Participants
OG00072
OG001143
OG002286
OG00365
OG004125
OG005129
OG006129
Title
Denominators
Categories
Title
Measurements
OG00066.7
OG00165.7
OG00267.1
OG00381.5
OG00476.0
OG00579.1
OG00681.4
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
OG003
Placebo/BKZ Dosing Regimen 2
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
OG004
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
OG005
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
OG006
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
Units
Counts
Participants
OG00072
OG001143
OG002286
OG00365
OG004125
OG005129
OG006129
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012.8
OG0022.1
OG0039.2
OG0048.0
OG0055.4
OG0067.8
BKZ Dosing Regimen 2
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
OG003
Placebo/BKZ Dosing Regimen 2
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
OG004
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
OG005
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
OG006
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).