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
2 other identifiers
interventional
509
14 countries
91
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2020
Typical duration for phase_3
91 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2020
CompletedFirst Posted
Study publicly available on registry
January 27, 2020
CompletedStudy Start
First participant enrolled
March 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2022
CompletedResults Posted
Study results publicly available
December 5, 2024
CompletedMay 19, 2026
May 1, 2026
1.7 years
January 23, 2020
November 8, 2024
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Week 16
Secondary Outcomes (8)
Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16
Week 16
Percentage of Participants With Flare by Week 16
From Baseline to Week 16
Absolute Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
Baseline, Week 16
Absolute Change From Baseline in Worst Skin Pain Score at Week 16
Baseline, Week 16
Percentage of Participants Achieving Skin Pain Response at Week 16
Week 16
- +3 more secondary outcomes
Study Arms (4)
Bimekizumab dosing regimen 1
EXPERIMENTALSubjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the Treatment Period.
Bimekizumab dosing regimen 2
EXPERIMENTALSubjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the Treatment Period.
Bimekizumab dosing regimen 3
EXPERIMENTALSubjects participating in the study will receive assigned bimekizumab dosing regimen 3 during the Treatment Period.
Placebo Group
PLACEBO COMPARATORSubjects randomized to this arm will receive placebo during the Initial Treatment Period and bimekizumab during the Maintenance Treatment Period.
Interventions
Subjects will receive bimekizumab at pre-specified time-points.
Subjects will receive placebo at pre-specified time-points during the Initial Treatment Period.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (91)
Hs0004 50162
Fountain Valley, California, 92708, United States
Hs0004 50196
Thousand Oaks, California, 91320, United States
Hs0004 50199
Miami, Florida, 33125, United States
Hs0004 50152
Orange Park, Florida, 32073, United States
Hs0004 50144
Orlando, Florida, 38219, United States
Hs0004 50184
Pembroke Pines, Florida, 33028, United States
Hs0004 50193
Sandy Springs, Georgia, 30328, United States
Hs0004 50223
Savannah, Georgia, 31419, United States
Hs0004 50164
Skokie, Illinois, 60077, United States
Hs0004 50234
Plainfield, Indiana, 46168, United States
Hs0004 50178
Clarkston, Michigan, 48346, United States
Hs0004 50105
St Louis, Missouri, 63110, United States
Hs0004 50197
Henderson, Nevada, 89052, United States
Hs0004 50159
Portsmouth, New Hampshire, 03801, United States
Hs0004 50200
Verona, New Jersey, 07044, United States
Hs0004 50237
Albuquerque, New Mexico, 87106, United States
Hs0004 50211
Durham, North Carolina, 27710, United States
Hs0004 50179
Winston-Salem, North Carolina, 27104, United States
Hs0004 50145
Columbus, Ohio, 43230, United States
Hs0004 50202
Fairborn, Ohio, 45324, United States
Hs0004 50150
Philadelphia, Pennsylvania, 19103, United States
Hs0004 50236
Greenville, South Carolina, 29615, United States
Hs0004 50084
Johns Island, South Carolina, 29425, United States
Hs0004 50148
Pflugerville, Texas, 78660, United States
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 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
Related Publications (7)
Kirby JS, Thorlacius L, Lambert J, Ciaravino V, Rolleri R, Pansar I, Muller E, Pelligra CG, Ingram JR. Psychometric validation and interpretation thresholds of the Hidradenitis Suppurativa Quality of Life (HiSQOL(c)) questionnaire using pooled data from the phase III BE HEARD I & II trials of bimekizumab in hidradenitis suppurativa. Br J Dermatol. 2025 Jun 20;193(1):93-104. doi: 10.1093/bjd/ljaf067.
PMID: 40172122RESULTIngram JR, Lambert J, Ciaravino V, Rolleri R, Pansar I, Peterson L, Pelligra CG, Thorlacius L. Hidradenitis Suppurativa Symptom Daily Diary (HSSDD) and Questionnaire (HSSQ): Psychometric Validation and Interpretation Threshold Derivation Using Phase 3 Study Data. Dermatol Ther (Heidelb). 2025 May;15(5):1093-1111. doi: 10.1007/s13555-025-01346-w. Epub 2025 Mar 28.
PMID: 40153232RESULTShi VY, Ingram JR, Lev-Tov H, Schneider-Burrus S, Forman S, Porter ML, Hayama K, Thorlacius L, Lambert J, Vaux T, Lukowski B, Rolleri RL, Szepietowski JC. Bimekizumab Impact on Patient-Reported Outcomes in Patients with Moderate to Severe Hidradenitis Suppurativa: Pooled 48-Week Results from BE HEARD I&II. Dermatol Ther (Heidelb). 2025 Sep;15(9):2553-2570. doi: 10.1007/s13555-025-01465-4. Epub 2025 Jul 13.
PMID: 40652434RESULTIngram JR, Fujita H, Gottlieb AB, Lev-Tov H, Prens E, Sayed CJ, Shi VY, Szepietowski JC, Takahashi K, Frew JW, Lambert J, Davis L, Oh T, Rolleri R, Saintmard MH, Orenstein LAV. Bimekizumab Pain Outcomes in Patients with Hidradenitis Suppurativa: Pooled 48-Week Results from BE HEARD I&II Phase 3 Randomized Clinical Trials. Pain Ther. 2025 Dec;14(6):1861-1878. doi: 10.1007/s40122-025-00779-7. Epub 2025 Oct 17.
PMID: 41107641RESULTTzellos T, Giamarellos-Bourboulis EJ, van Straalen KR, Martorell A, Kirby B, Alavi A, Hayama K, Khattri S, Gulliver W, Sayed CJ, Davis L, Rolleri RL, Crater C, Pansar I, Lambert J, Zouboulis CC. Bimekizumab efficacy using IHS4 outcomes in hidradenitis suppurativa: Results from BE HEARD I and II. J Eur Acad Dermatol Venereol. 2026 Feb 14. doi: 10.1111/jdv.70356. Online ahead of print.
PMID: 41689425RESULTSayed CJ, Kirby B, Garg A, Naik HB, Kimball AB, Zouboulis CC, Jemec GBE, Kokolakis G, Ingram JR, Morita A, Deherder D, Crater C, Rolleri RL, Vaux T, Lambert J, Lukowski B, Bechara FG. Bimekizumab demonstrated a favorable safety profile and high levels of efficacy with up to 2 years of treatment in patients with moderate to severe hidradenitis suppurativa: Pooled results from two phase 3 randomized, controlled trials and their open-label extension. J Am Acad Dermatol. 2026 Mar;94(3):867-878. doi: 10.1016/j.jaad.2025.11.031. Epub 2025 Nov 15.
PMID: 41248770RESULTKimball AB, Jemec GBE, Sayed CJ, Kirby JS, Prens E, Ingram JR, Garg A, Gottlieb AB, Szepietowski JC, Bechara FG, Giamarellos-Bourboulis EJ, Fujita H, Rolleri R, Joshi P, Dokhe P, Muller E, Peterson L, Madden C, Bari M, Zouboulis CC. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48-week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials. Lancet. 2024 Jun 8;403(10443):2504-2519. doi: 10.1016/S0140-6736(24)00101-6. Epub 2024 May 22.
PMID: 38795716DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2020
First Posted
January 27, 2020
Study Start
March 2, 2020
Primary Completion
November 9, 2021
Study Completion
September 28, 2022
Last Updated
May 19, 2026
Results First Posted
December 5, 2024
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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.