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 April 2026 by UCB Biopharma SRL
Sponsor
UCB Biopharma SRL
Information Provided by (Responsible Party)
UCB Biopharma SRL
Clinicaltrials.gov Identifier
NCT04242498
Other Study ID Numbers:
HS0004
First Submitted
January 22, 2020
First Posted
January 26, 2020
Results First Posted
November 7, 2024
Last Update Posted
May 18, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on May 2026. Link 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 Enrollment509 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 DateMarch 1, 2020
Actual Primary Completion DateNovember 8, 2021
Actual Study Completion DateSeptember 27, 2022

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. Percentages 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. Percentages of participants shown do not account for model effects using the logistic regression model.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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).
  7. 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).
  8. 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.

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 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
Hs0004 50162 | Fountain Valley California, United States, 92708Hs0004 50196 | Thousand Oaks California, United States, 91320Hs0004 50199 | Miami Florida, United States, 33125Hs0004 50152 | Orange Park Florida, United States, 32073Hs0004 50144 | Orlando Florida, United States, 38219Hs0004 50184 | Pembroke Pines Florida, United States, 33028Hs0004 50193 | Sandy Springs Georgia, United States, 30328Hs0004 50223 | Savannah Georgia, United States, 31419Hs0004 50164 | Skokie Illinois, United States, 60077Hs0004 50234 | Plainfield Indiana, United States, 46168Hs0004 50178 | Clarkston Michigan, United States, 48346Hs0004 50105 | St Louis Missouri, United States, 63110Hs0004 50197 | Henderson Nevada, United States, 89052Hs0004 50159 | Portsmouth New Hampshire, United States, 03801Hs0004 50200 | Verona New Jersey, United States, 07044Hs0004 50237 | Albuquerque New Mexico, United States, 87106Hs0004 50211 | Durham North Carolina, United States, 27710Hs0004 50179 | Winston-Salem North Carolina, United States, 27104Hs0004 50145 | Columbus Ohio, United States, 43230Hs0004 50202 | Fairborn Ohio, United States, 45324Hs0004 50150 | Philadelphia Pennsylvania, United States, 19103Hs0004 50236 | Greenville South Carolina, United States, 29615Hs0004 50084 | Johns Island South Carolina, United States, 29425Hs0004 50148 | Pflugerville Texas, United States, 78660Hs0004 30018 | Parkville , Australia, Hs0004 30014 | St Leonards , Australia, Hs0004 30009 | Westmead , Australia, Hs0004 40313 | Pleven , Bulgaria, Hs0004 40284 | Sofia , Bulgaria, Hs0004 40311 | Sofia , Bulgaria, Hs0004 40314 | Sofia , Bulgaria, Hs0004 40315 | Sofia , Bulgaria, Hs0004 40353 | Stara Zagora , Bulgaria, Hs0004 50172 | Cobourg , Canada, Hs0004 50135 | Edmonton , Canada, Hs0004 50174 | London , Canada, Hs0004 50189 | St. John's , Canada, Hs0004 50134 | Waterloo , Canada, Hs0004 50136 | Winnipeg , Canada, Hs0004 40063 | Prague , Czechia, Hs0004 40194 | Prague , Czechia, Hs0004 40245 | Antony , France, Hs0004 40321 | Auxerre , France, Hs0004 40129 | Bordeaux , France, Hs0004 40320 | La Rochelle , France, Hs0004 40247 | Lyon , France, Hs0004 40130 | Marseille , France, Hs0004 40404 | Reims , France, Hs0004 40403 | Saint-Etienne , France, Hs0004 40286 | Toulouse , France, Hs0004 40289 | Berlin , Germany, Hs0004 40326 | Berlin , Germany, Hs0004 40322 | Dessau , Germany, Hs0004 40356 | Dresden , Germany, Hs0004 40287 | Frankfurt am Main , Germany, Hs0004 40142 | Hamburg , Germany, Hs0004 40328 | Hanover , Germany, Hs0004 40250 | Lübeck , Germany, Hs0004 40254 | Debrecen , Hungary, Hs0004 40344 | Dublin , Ireland, Hs0004 20090 | Afula , Israel, Hs0004 20196 | Bunkyō City , Japan, Hs0004 20144 | Fukuoka , Japan, Hs0004 20043 | Itabashi-ku , Japan, Hs0004 20195 | Kagoshima , Japan, Hs0004 20170 | Kurume , Japan, Hs0004 20190 | Kyoto , Japan, Hs0004 20033 | Nagoya , Japan, Hs0004 20152 | Nakagami-gun , Japan, Hs0004 20178 | Nishinomiya , Japan, Hs0004 20153 | Obihiro , Japan, Hs0004 20037 | Osaka , Japan, Hs0004 20154 | Sapporo , Japan, Hs0004 20171 | Sendai , Japan, Hs0004 40347 | Lodz , Poland, Hs0004 40293 | Rzeszów , Poland, Hs0004 40335 | Warsaw , Poland, Hs0004 40095 | Wroclaw , Poland, Hs0004 40333 | Wroclaw , Poland, Hs0004 40334 | Wroclaw , Poland, Hs0004 40159 | Barcelona , Spain, Hs0004 40267 | Barcelona , Spain, Hs0004 40298 | Granada , Spain, Hs0004 40268 | Madrid , Spain, Hs0004 40297 | Manises , Spain, Hs0004 40101 | Sabadell , Spain, Hs0004 40300 | Cardiff , United Kingdom, Hs0004 40339 | Leeds , United Kingdom, Hs0004 40113 | London , United Kingdom, Hs0004 40240 | Newcastle upon Tyne , United Kingdom, Hs0004 40338 | Northampton , United Kingdom,
Investigators
Study Director: UCB Cares, 001 844 599 2273
Study Documents (Full Text)
Documents provided by UCB Biopharma SRL: Study Protocol  May 5, 2022Documents provided by UCB Biopharma SRL: Statistical Analysis Plan  July 5, 2022