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

ClinicalTrials.gov processed this data on October 16, 2023. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED (See Contacts and Locations)
Verified October 2023 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 23, 2020
First Posted: January 27, 2020
Last Update Posted: October 17, 2023
Last Verified: October 2023
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Hidradenitis Suppurativa
  • Drug: Bimekizumab
  • Other: Placebo

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 2, 2020
Actual Primary Completion DateNovember 9, 2021
Actual Study Completion DateSeptember 28, 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.
  • Other: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16 [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.

    Secondary Outcome Measures

    1. Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16 [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.
    2. Percentage of participants with Flare by Week 16 [Week 16]
      Flare is defined as a ≥25% increase in AN count with an absolute increase in AN count of ≥2 relative to Baseline.
    3. Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 [From Baseline (Day 1) to 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.
    4. Absolute change from Baseline in Skin Pain score at Week 16 [From Baseline (Day 1) to 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).
    5. Percentage of participants achieving Skin Pain response at Week 16 [From Baseline (Day 1) to 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.
    6. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study [From Baseline (Day 1) until Safety Follow-Up (up to Week 71)]
      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.
    7. Percentage of participants with serious treatment-emergent adverse events during the study [From Baseline (Day 1) until Safety Follow-Up (up to Week 71)]
      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
    8. Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study [From Baseline (Day 1) until Safety Follow-Up (up to Week 71)]
      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.

    Eligibility Criteria

    Ages Eligible for Study 18 Years and Older (Adult, Older Adult)
    Sexes Eligible for Study All
    Accepts Healthy Volunteers No
    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

    Contacts and Locations

    Sponsors and Collaborators UCB Biopharma SRL
    Locations
    • Hs0004 50162 | Fountain Valley, California, United States, 92708
    • Hs0004 50196 | Thousand Oaks, California, United States, 91320
    • Hs0004 50199 | Miami, Florida, United States, 33125
    • Hs0004 50152 | Orange Park, Florida, United States, 32073
    • Hs0004 50144 | Orlando, Florida, United States, 38219
    • Hs0004 50184 | Pembroke Pines, Florida, United States, 33028
    • Hs0004 50193 | Sandy Springs, Georgia, United States, 30328
    • Hs0004 50223 | Savannah, Georgia, United States, 31419
    • Hs0004 50164 | Skokie, Illinois, United States, 60077
    • Hs0004 50234 | Plainfield, Indiana, United States, 46168
    • Hs0004 50178 | Clarkston, Michigan, United States, 48346
    • Hs0004 50105 | Saint Louis, Missouri, United States, 63110
    • Hs0004 50197 | Henderson, Nevada, United States, 89052
    • Hs0004 50159 | Portsmouth, New Hampshire, United States, 03801
    • Hs0004 50200 | Verona, New Jersey, United States, 07044
    • Hs0004 50237 | Albuquerque, New Mexico, United States, 87106
    • Hs0004 50211 | Durham, North Carolina, United States, 27710
    • Hs0004 50179 | Winston-Salem, North Carolina, United States, 27104
    • Hs0004 50145 | Columbus, Ohio, United States, 43230
    • Hs0004 50202 | Fairborn, Ohio, United States, 45324
    • Hs0004 50150 | Philadelphia, Pennsylvania, United States, 19103
    • Hs0004 50236 | Greenville, South Carolina, United States, 29615
    • Hs0004 50084 | Johns Island, South Carolina, United States, 29425
    • Hs0004 50148 | Pflugerville, Texas, United States, 78660
    • Hs0004 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 40194 | Praha 10, Czechia,
    • Hs0004 40063 | Praha 5, Czechia,
    • Hs0004 40245 | Antony, France,
    • Hs0004 40321 | Auxerre, France,
    • Hs0004 40129 | Bordeaux Cedex, 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/main, Germany,
    • Hs0004 40142 | Hamburg, Germany,
    • Hs0004 40328 | Hannover, Germany,
    • Hs0004 40250 | Lübeck, Germany,
    • Hs0004 40254 | Debrecen, Hungary,
    • Hs0004 40344 | Dublin, Ireland,
    • Hs0004 20090 | Afula, Israel,
    • Hs0004 20196 | Bunkyo-ku, 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 | Rzeszow, Poland,
    • Hs0004 40335 | Warszawa, 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

      More Information

      Additional Relevant MeSH Terms

      • Hidradenitis Suppurativa
      • Hidradenitis
      • Sweat Gland Diseases
      • Skin Diseases
      • Skin Diseases, Bacterial
      • Bacterial Infections
      • Bacterial Infections and Mycoses
      • Infections
      • Skin Diseases, Infectious
      • Suppuration