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

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified March 2026 by UCB Biopharma SRL
Sponsor
UCB Biopharma SRL
Information Provided by (Responsible Party)
UCB Biopharma SRL
Clinicaltrials.gov Identifier
NCT04242446
Other Study ID Numbers:
HS0003
First Submitted
January 22, 2020
First Posted
January 26, 2020
Results First Posted
December 17, 2024
Last Update Posted
April 13, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Hidradenitis Suppurativa
Drug: BimekizumabDrug: BimekizumabDrug: BimekizumabDrug: Bimekizumab

Study Design

Study TypeInterventional
Actual Enrollment505 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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
Study Start DateFebruary 18, 2020
Actual Primary Completion DateApril 6, 2022
Actual Study Completion DateFebruary 18, 2023

Groups and Cohorts

Group/CohortIntervention/Treatment
Bimekizumab dosing regimen 1
Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the Treatment Period.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Bimekizumab dosing regimen 2
Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the Treatment Period.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Bimekizumab dosing regimen 3
Subjects participating in the study will receive assigned bimekizumab dosing regimen 3 during the Treatment Period.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Placebo Group
Subjects randomized to this arm will receive placebo during the Initial Treatment Period and bimekizumab during the Maintenance Treatment Period.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.

Outcome Measures

Primary Outcome Measures
  1. 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.
Secondary Outcome Measures
  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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).
  6. 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).
  7. 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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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
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

Contacts and Locations

Sponsors and CollaboratorsUCB Biopharma SRL
Locations
Hs0003 50140 | Birmingham Alabama, United States, 35233Hs0003 50175 | Phoenix Arizona, United States, 85006Hs0003 50161 | Los Angeles California, United States, 90045Hs0003 50220 | San Diego California, United States, 92123Hs0003 50205 | North Miami Beach Florida, United States, 33162-4708Hs0003 50153 | Ormond Beach Florida, United States, 32174Hs0003 50141 | Tampa Florida, United States, 33613Hs0003 50210 | Atlanta Georgia, United States, 30309Hs0003 50280 | Watkinsville Georgia, United States, 30677Hs0003 50425 | Murray Kentucky, United States, 42071Hs0003 50198 | Beverly Massachusetts, United States, 01915Hs0003 50146 | Boston Massachusetts, United States, 02215Hs0003 50194 | Omaha Nebraska, United States, 68144Hs0003 50208 | Las Vegas Nevada, United States, 89148Hs0003 50137 | East Windsor New Jersey, United States, 08520Hs0003 50235 | New York New York, United States, 10003Hs0003 50151 | Chapel Hill North Carolina, United States, 27516Hs0003 50177 | Cincinnati Ohio, United States, 45219Hs0003 50138 | Columbus Ohio, United States, 43213Hs0003 50204 | Tulsa Oklahoma, United States, 74135Hs0003 50147 | Hershey Pennsylvania, United States, 17033Hs0003 50008 | Johnston Rhode Island, United States, 02919Hs0003 50180 | Providence Rhode Island, United States, 02903Hs0003 50142 | Nashville Tennessee, United States, 37215Hs0003 50201 | Arlington Texas, United States, 76011Hs0003 50166 | Dallas Texas, United States, 75246Hs0003 50149 | San Antonio Texas, United States, 78213Hs0003 50270 | Seattle Washington, United States, 98101Hs0003 30015 | Campbelltown , Australia, Hs0003 30016 | Carlton , Australia, Hs0003 30011 | East Melbourne , Australia, Hs0003 30017 | Kogarah , Australia, Hs0003 30012 | Woolloongabba , Australia, Hs0003 40004 | Brussels , Belgium, Hs0003 40121 | Brussels , Belgium, Hs0003 40002 | Leuven , Belgium, Hs0003 40060 | Liège , Belgium, Hs0003 50233 | Barrie , Canada, Hs0003 50190 | Richmond Hill , Canada, Hs0003 50192 | Saskatoon , Canada, Hs0003 50173 | St. John's , Canada, Hs0003 50133 | Surrey , Canada, Hs0003 40127 | Aarhus N , Denmark, Hs0003 40197 | Amiens , France, Hs0003 40342 | Angers , France, Hs0003 40355 | Le Mans , France, Hs0003 40132 | Nice , France, Hs0003 40318 | Rouen , France, Hs0003 40246 | Saint-Mandé , France, Hs0003 40285 | Toulon , France, Hs0003 40325 | Berlin , Germany, Hs0003 40248 | Bochum , Germany, Hs0003 40327 | Bonn , Germany, Hs0003 40288 | Darmstadt , Germany, Hs0003 40324 | Dresden , Germany, Hs0003 40249 | Kiel , Germany, Hs0003 40357 | Magdeburg , Germany, Hs0003 40174 | Mainz , Germany, Hs0003 40323 | München , Germany, Hs0003 40177 | Münster , Germany, Hs0003 40251 | Athens , Greece, Hs0003 40253 | Athens , Greece, Hs0003 40252 | Thessaloniki , Greece, Hs0003 20089 | Haifa , Israel, Hs0003 20088 | Tel Aviv , Israel, Hs0003 40261 | Catania , Italy, Hs0003 40257 | Roma , Italy, Hs0003 40263 | Roma , Italy, Hs0003 40258 | Rozzano , Italy, Hs0003 40331 | Terracina , Italy, Hs0003 40330 | Torino , Italy, Hs0003 40351 | Breda , Netherlands, Hs0003 40292 | Groningen , Netherlands, Hs0003 40264 | Rotterdam , Netherlands, Hs0003 40332 | Trondheim , Norway, Hs0003 40266 | Badalona , Spain, Hs0003 40294 | Las Palmas de Gran Canaria , Spain, Hs0003 40295 | Pontevedra , Spain, Hs0003 40049 | Seville , Spain, Hs0003 40230 | Valencia , Spain, Hs0003 40337 | Bern , Switzerland, Hs0003 40406 | Geneva , Switzerland, Hs0003 40053 | Ankara , Turkey (Türkiye), Hs0003 40270 | Antalya , Turkey (Türkiye), Hs0003 40273 | Gaziantep , Turkey (Türkiye), Hs0003 40050 | Istanbul , Turkey (Türkiye), Hs0003 40272 | Istanbul , Turkey (Türkiye), Hs0003 40271 | Izmir , Turkey (Türkiye),
Investigators
Study Director: UCB Cares, 001 844 599 2273
Study Documents (Full Text)
Documents provided by UCB Biopharma SRLStudy Protocol  September 26, 2022Documents provided by UCB Biopharma SRLStatistical Analysis Plan  October 6, 2022