A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)

Official Title
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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

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Drug: Bimekizumab
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bimekizumab dosing regimen 1<br>Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the Treatment Period. | Drug: Bimekizumab<br>* Subjects will receive bimekizumab at pre-specified time-points.<br>* Other names: UCB4940;|
| Experimental: Bimekizumab dosing regimen 2<br>Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the Treatment Period. | Drug: Bimekizumab<br>* Subjects will receive bimekizumab at pre-specified time-points.<br>* Other names: UCB4940;|
| Experimental: Bimekizumab dosing regimen 3<br>Subjects participating in the study will receive assigned bimekizumab dosing regimen 3 during the Treatment Period. | Drug: Bimekizumab<br>* Subjects will receive bimekizumab at pre-specified time-points.<br>* Other names: UCB4940;|
| Placebo Comparator: Placebo Group<br>Subjects randomized to this arm will receive placebo during the Initial Treatment Period and bimekizumab during the Maintenance Treatment Period. | Drug: Bimekizumab<br>* Subjects will receive bimekizumab at pre-specified time-points.<br>* Other names: UCB4940;Other: Placebo<br>* Subjects will receive placebo at pre-specified time-points during the Initial Treatment Period.<br>* Other names: PBO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16 | HiSCR50 is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count. | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16 | HiSCR75 is defined as at least a 75% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count. | Week 16 | 
| Percentage of participants with Flare by Week 16 | Flare is defined as a ≥25% increase in AN count with an absolute increase in AN count of ≥2 relative to Baseline. | Week 16 | 
| Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 | The DLQI is a skin disease specific questionnaire aimed at the evaluation of how symptoms and treatment affect participants' health related quality of life (QOL). The DLQI total score ranges from 0 to 30 with higher scores indicating lower skin health related QOL. | From Baseline (Day 1) to Week 16 | 
| Absolute change from Baseline in Skin Pain score at Week 16 | Skin Pain score is assessed by the worst pain item (11 point numeric rating scale) in the Hidradenitis Suppurativa Symptom Daily Diary (HSSDD). | From Baseline (Day 1) to Week 16 | 
| Percentage of participants achieving Skin Pain response at Week 16 | Pain response is defined as a decrease from Baseline in Hidradenitis Suppurativa Symptom Daily Diary (HSSDD) weekly worst skin pain score at or beyond the threshold for within-patient clinically meaningful change. | From Baseline (Day 1) to Week 16 | 
| Percentage of participants with treatment-emergent adverse events (TEAEs) during the study | An adverse event (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. NOTE: An AE can 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. | 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 | 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 adverse event (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. NOTE: An AE can 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 leading to discontinuation of the study are reported. | From Baseline (Day 1) until Safety Follow-Up (up to Week 71) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UCB4940, Bimekizumab, HS, Hidradenitis Suppurativa, Acne inversa