A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD II)

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

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

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: Bimekizumab; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 509
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Parkville, Australia
    • Hs0004 30018
  • St Leonards, Australia
    • Hs0004 30014
  • Westmead, Australia
    • Hs0004 30009
• Bulgaria
  • Pleven, Bulgaria
    • Hs0004 40313
  • Sofia, Bulgaria
    • Hs0004 40284
  • Sofia, Bulgaria
    • Hs0004 40311
  • Sofia, Bulgaria
    • Hs0004 40314
  • Sofia, Bulgaria
    • Hs0004 40315
  • Stara Zagora, Bulgaria
    • Hs0004 40353
• Canada
  • Cobourg, Canada
    • Hs0004 50172
  • Edmonton, Canada
    • Hs0004 50135
  • London, Canada
    • Hs0004 50174
  • St. John's, Canada
    • Hs0004 50189
  • Waterloo, Canada
    • Hs0004 50134
  • Winnipeg, Canada
    • Hs0004 50136
• Czechia
  • Praha 10, Czechia
    • Hs0004 40194
  • Praha 5, Czechia
    • Hs0004 40063
• France
  • Antony, France
    • Hs0004 40245
  • Auxerre, France
    • Hs0004 40321
  • Bordeaux Cedex, France
    • Hs0004 40129
  • La Rochelle, France
    • Hs0004 40320
  • Lyon, France
    • Hs0004 40247
  • Marseille, France
    • Hs0004 40130
  • Reims, France
    • Hs0004 40404
  • Saint-etienne, France
    • Hs0004 40403
  • Toulouse, France
    • Hs0004 40286
• Germany
  • Berlin, Germany
    • Hs0004 40289
  • Berlin, Germany
    • Hs0004 40326
  • Dessau, Germany
    • Hs0004 40322
  • Dresden, Germany
    • Hs0004 40356
  • Frankfurt/main, Germany
    • Hs0004 40287
  • Hamburg, Germany
    • Hs0004 40142
  • Hannover, Germany
    • Hs0004 40328
  • Lübeck, Germany
    • Hs0004 40250
• Hungary
  • Debrecen, Hungary
    • Hs0004 40254
• Ireland
  • Dublin, Ireland
    • Hs0004 40344
• Israel
  • Afula, Israel
    • Hs0004 20090
• Japan
  • Bunkyo-ku, Japan
    • Hs0004 20196
  • Fukuoka, Japan
    • Hs0004 20144
  • Itabashi-ku, Japan
    • Hs0004 20043
  • Kagoshima, Japan
    • Hs0004 20195
  • Kurume, Japan
    • Hs0004 20170
  • Kyoto, Japan
    • Hs0004 20190
  • Nagoya, Japan
    • Hs0004 20033
  • Nakagami-gun, Japan
    • Hs0004 20152
  • Nishinomiya, Japan
    • Hs0004 20178
  • Obihiro, Japan
    • Hs0004 20153
  • Osaka, Japan
    • Hs0004 20037
  • Sapporo, Japan
    • Hs0004 20154
  • Sendai, Japan
    • Hs0004 20171
• Poland
  • Lodz, Poland
    • Hs0004 40347
  • Rzeszow, Poland
    • Hs0004 40293
  • Warszawa, Poland
    • Hs0004 40335
  • Wroclaw, Poland
    • Hs0004 40095
  • Wroclaw, Poland
    • Hs0004 40333
  • Wroclaw, Poland
    • Hs0004 40334
• Spain
  • Barcelona, Spain
    • Hs0004 40159
  • Barcelona, Spain
    • Hs0004 40267
  • Granada, Spain
    • Hs0004 40298
  • Madrid, Spain
    • Hs0004 40268
  • Manises, Spain
    • Hs0004 40297
  • Sabadell, Spain
    • Hs0004 40101
• United Kingdom
  • Cardiff, United Kingdom
    • Hs0004 40300
  • Leeds, United Kingdom
    • Hs0004 40339
  • London, United Kingdom
    • Hs0004 40113
  • Newcastle Upon Tyne, United Kingdom
    • Hs0004 40240
  • Northampton, United Kingdom
    • Hs0004 40338
• United States
  • California
    • Fountain Valley, California, United States, 92708
      • Hs0004 50162
    • Thousand Oaks, California, United States, 91320
      • Hs0004 50196
  • Florida
    • Miami, Florida, United States, 33125
      • Hs0004 50199
    • Orange Park, Florida, United States, 32073
      • Hs0004 50152
    • Orlando, Florida, United States, 38219
      • Hs0004 50144
    • Pembroke Pines, Florida, United States, 33028
      • Hs0004 50184
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Hs0004 50193
    • Savannah, Georgia, United States, 31419
      • Hs0004 50223
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Hs0004 50164
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • Hs0004 50234
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Hs0004 50178
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Hs0004 50105
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Hs0004 50197
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Hs0004 50159
  • New Jersey
    • Verona, New Jersey, United States, 07044
      • Hs0004 50200
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Hs0004 50237
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Hs0004 50211
    • Winston-Salem, North Carolina, United States, 27104
      • Hs0004 50179
  • Ohio
    • Columbus, Ohio, United States, 43230
      • Hs0004 50145
    • Fairborn, Ohio, United States, 45324
      • Hs0004 50202
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Hs0004 50150
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Hs0004 50236
    • Johns Island, South Carolina, United States, 29425
      • Hs0004 50084
  • Texas
    • Pflugerville, Texas, United States, 78660
      • Hs0004 50148

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.; Other Names: UCB4940
Experimental: 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.; Other Names: UCB4940
Experimental: 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.; Other Names: UCB4940
Placebo Comparator: 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 Names: UCB4940; Other: Placebo; Subjects will receive placebo at pre-specified time-points during the Initial Treatment Period.; Other Names: PBO

What is the study measuring?

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
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)
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

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL
• Investigators: Study Director: UCB Cares, 001 844 599 2273

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Actual): November 9, 2021
• Study Completion (Actual): September 28, 2022

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: January 23, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Bimekizumab; HS; UCB4940; Hidradenitis Suppurativa; Acne inversa
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: HS0004; 2019-002551-42 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
• IPD Sharing Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• IPD Sharing Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No