A Study to Evaluate the Efficacy and Safety of Bimekizuma... | NCT04242498

ID	Type	Description	Link
2019-002551-42	EudraCT Number

Status Module

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. Percentages 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. Percentages of participants shown do not account for model effects using the logistic regression model.

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:
1. Not a woman of childbearing potential (WOCBP) OR
2. 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 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

Name	Affiliation	Role
UCB Cares	001 844 599 2273	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Hs0004 50162		Fountain Valley	California	92708	United States
Hs0004 50196

PubMed Identifier	Type	Citation	Retractions
40172122	Result	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.
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IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received placebo during the 16-weeks Initial Treatment Period.
FG001	BKZ Dosing Regimen 1	Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 6, 2022	Nov 8, 2024

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0017 BG00210 BG003

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00038.1± 13.2 BG00135.2± 11.9 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00031 BG00177 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	BG0005 BG00110 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. Percentages of participants shown do not account for model effects using the logistic regression model.

The RS consisted of all study 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	OG00074 OG001144 OG002291

Title

Denominators

Categories

Title	Measurements
	OG00032.2(21.4 to 42.9) OG00153.8(45.4 to 62.1) OG00252.0(46.1 to 57.8)

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		0.004		Odds Ratio (OR)	2.422			2-Sided	97.5	1.221	4.804					Superiority
OG000 OG002		Regression, Logistic		0.003

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. Percentages of participants shown do not account for model effects using the logistic regression model.

The RS consisted of all study 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

Secondary

Percentage of Participants With Flare by Week 16

Flare was defined as a greater than or equal to (>=) 25% increase in AN count with an absolute increase in AN count of >= 2 relative to Baseline. 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 prior to experiencing a flare were treated as having experienced a flare at all flare assessments on and after the intercurrent event date. 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. Percentages of participants shown do not account for model effects using the logistic regression model.

The RS consisted of all study participants randomized into the study.

Posted

Number

95% Confidence Interval

percentage of participants

From Baseline to 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

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 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. Percentages 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. Treatment-emergent AEs are defined as those 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. Treatment-emergent AEs are defined as those 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. Treatment-emergent AEs are defined as those 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.

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

Arm/Groups

ID	Title	Description	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.	74	0	74	18	74
EG001	BKZ Dosing Regimen 1	Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.	142	3	142	40	142
EG002	BKZ Dosing Regimen 2	Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.	290	9	290	101	290
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).	69	2	69	26	69
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).	133	4	133	49	133
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).	130	3	130	57	130
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).	131	4	131	64	131

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected142 at risk EG0020 events0 affected290 at risk EG0030 events0 affected69 at risk EG004
Colitis ulcerative	Gastrointestinal disorders	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected142 at risk EG0021 events1 affected290 at risk EG003
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected142 at risk EG0021 events1 affected290 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected142 at risk EG0020 events0 affected290 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected142 at risk EG0020 events0 affected290 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected142 at risk EG0020 events0 affected290 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected142 at risk EG0020 events0 affected290 at risk EG003
Anal fistula	Gastrointestinal disorders	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected142 at risk EG0020 events0 affected290 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected142 at risk EG0021 events1 affected290 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected142 at risk EG0020 events0 affected290 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected142 at risk EG0020 events0 affected290 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected142 at risk EG0021 events1 affected290 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected142 at risk EG0021 events1 affected290 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected142 at risk EG0021 events1 affected290 at risk EG003
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected142 at risk EG0022 events2 affected290 at risk EG003
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected142 at risk EG0021 events1 affected290 at risk EG003
Appendicitis	Infections and infestations	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected142 at risk EG0020 events0 affected290 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected142 at risk EG0020 events0 affected290 at risk EG003
Bartholinitis	Infections and infestations	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected142 at risk EG0020 events0 affected290 at risk EG003
Rash pustular	Infections and infestations	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected142 at risk EG0020 events0 affected290 at risk EG003
Corona virus infection	Infections and infestations	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected142 at risk EG0020 events0 affected290 at risk EG003
Pregnancy on contraceptive	Pregnancy, puerperium and perinatal conditions	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected142 at risk EG0020 events0 affected290 at risk EG003
Depression	Psychiatric disorders	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected142 at risk EG0020 events0 affected290 at risk EG003
Lymphoedema	Vascular disorders	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected142 at risk EG0020 events0 affected290 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected142 at risk EG0020 events0 affected290 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA v19.0	Non-systematic Assessment	EG0007 events6 affected74 at risk EG0016 events5 affected142 at risk EG00221 events18 affected290 at risk EG0033 events2 affected69 at risk EG0048 events6 affected133 at risk EG0055 events4 affected130 at risk EG0063 events3 affected131 at risk
Oral candidiasis	Infections and infestations	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0015 events5 affected142 at risk EG00226 events24 affected290 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0018 events8 affected142 at risk EG0021 events1 affected290 at risk EG003
Headache	Nervous system disorders	MedDRA v19.0	Non-systematic Assessment	EG0009 events7 affected74 at risk EG0019 events7 affected142 at risk EG00221 events18 affected290 at risk EG003
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA v19.0	Non-systematic Assessment	EG0006 events5 affected74 at risk EG00115 events13 affected142 at risk EG00227 events23 affected290 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0013 events3 affected142 at risk EG00211 events11 affected290 at risk EG003
Folliculitis	Infections and infestations	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0015 events5 affected142 at risk EG0029 events8 affected290 at risk EG003
Corona virus infection	Infections and infestations	MedDRA v19.0	Non-systematic Assessment	EG0000 events0 affected74 at risk EG0013 events3 affected142 at risk EG00211 events11 affected290 at risk EG003
Rhinitis	Infections and infestations	MedDRA v19.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0011 events1 affected142 at risk EG0020 events0 affected290 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA v19.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected142 at risk EG0026 events5 affected290 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA v19.0	Non-systematic Assessment	EG0001 events1 affected74 at risk EG0011 events1 affected142 at risk EG00210 events9 affected290 at risk EG003

ID	Term
D017192	Skin Diseases, Bacterial
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D012874	Skin Diseases, Infectious
D013492	Suppuration
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D016575	Hidradenitis
D013543	Sweat Gland Diseases

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