Hidradenitis SuppurativaPhase 3BE HEARD INCT04242446
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
A Phase 3 study testing Bimekizumab in people with Hidradenitis Suppurativa, run by UCB Biopharma SRL at 88 sites in 15 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Bimekizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 505 participants
- Where
- 88 sitesin 15 countries
- Study dates
- 19 Feb 2020to 19 Feb 2023
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
88 sites in 15 countries.
88 sites in 15 countries
United States28 sites
Hs0003 50201
Arlington, Texas, 76011
Hs0003 50210
Atlanta, Georgia, 30309
Hs0003 50198
Beverly, Massachusetts, 01915
Hs0003 50140
Birmingham, Alabama, 35233
Hs0003 50146
Boston, Massachusetts, 02215
Hs0003 50151
Chapel Hill, North Carolina, 27516
Hs0003 50177
Cincinnati, Ohio, 45219
Hs0003 50138
Columbus, Ohio, 43213
Hs0003 50166
Dallas, Texas, 75246
Hs0003 50137
East Windsor, New Jersey, 08520
Hs0003 50147
Hershey, Pennsylvania, 17033
Hs0003 50008
Johnston, Rhode Island, 02919
Hs0003 50208
Las Vegas, Nevada, 89148
Hs0003 50161
Los Angeles, California, 90045
Hs0003 50425
Murray, Kentucky, 42071
Hs0003 50142
Nashville, Tennessee, 37215
Hs0003 50235
New York, New York, 10003
Hs0003 50205
North Miami Beach, Florida, 33162-4708
Hs0003 50194
Omaha, Nebraska, 68144
Hs0003 50153
Ormond Beach, Florida, 32174
Hs0003 50175
Phoenix, Arizona, 85006
Hs0003 50180
Providence, Rhode Island, 02903
Hs0003 50149
San Antonio, Texas, 78213
Hs0003 50220
San Diego, California, 92123
Hs0003 50270
Seattle, Washington, 98101
Hs0003 50141
Tampa, Florida, 33613
Hs0003 50204
Tulsa, Oklahoma, 74135
Hs0003 50280
Watkinsville, Georgia, 30677
Germany10 sites
Hs0003 40325
Berlin
Hs0003 40248
Bochum
Hs0003 40327
Bonn
Hs0003 40288
Darmstadt
Hs0003 40324
Dresden
Hs0003 40249
Kiel
Hs0003 40357
Magdeburg
Hs0003 40174
Mainz
Hs0003 40323
München
Hs0003 40177
Münster
France7 sites
Hs0003 40197
Amiens
Hs0003 40342
Angers
Hs0003 40355
Le Mans
Hs0003 40132
Nice
Hs0003 40318
Rouen
Hs0003 40246
Saint-Mandé
Hs0003 40285
Toulon
Italy6 sites
Hs0003 40261
Catania
Hs0003 40257
Roma
Hs0003 40263
Roma
Hs0003 40258
Rozzano
Hs0003 40331
Terracina
Hs0003 40330
Torino
Turkey (Türkiye)6 sites
Hs0003 40053
Ankara
Hs0003 40270
Antalya
Hs0003 40273
Gaziantep
Hs0003 40050
Istanbul
Hs0003 40272
Istanbul
Hs0003 40271
Izmir
Australia5 sites
Hs0003 30015
Campbelltown
Hs0003 30016
Carlton
Hs0003 30011
East Melbourne
Hs0003 30017
Kogarah
Hs0003 30012
Woolloongabba
Canada5 sites
Hs0003 50233
Barrie
Hs0003 50190
Richmond Hill
Hs0003 50192
Saskatoon
Hs0003 50173
St. John's
Hs0003 50133
Surrey
Spain5 sites
Hs0003 40266
Badalona
Hs0003 40294
Las Palmas de Gran Canaria
Hs0003 40295
Pontevedra
Hs0003 40049
Seville
Hs0003 40230
Valencia
Belgium4 sites
Hs0003 40004
Brussels
Hs0003 40121
Brussels
Hs0003 40002
Leuven
Hs0003 40060
Liège
Netherlands3 sites
Hs0003 40351
Breda
Hs0003 40292
Groningen
Hs0003 40264
Rotterdam
About this study
Official title: 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)
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Bimekizumab, Placebo
- Keywords
- Bimekizumab, UCB4940, HS, Hidradenitis Suppurativa, Acne inversa
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BimekizumabDrug
Also called UCB4940
Subjects will receive bimekizumab at pre-specified time-points.
PlaceboOther
Also called PBO
Subjects will receive placebo at pre-specified time-points during the Initial Treatment Period.
| Study group | Role | What they receive |
|---|---|---|
| Bimekizumab dosing regimen 1 | Experimental | Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the Treatment Period. Receives: Drug: Bimekizumab |
| Bimekizumab dosing regimen 2 | Experimental | Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the Treatment Period. Receives: Drug: Bimekizumab |
| Bimekizumab dosing regimen 3 | Experimental | Subjects participating in the study will receive assigned bimekizumab dosing regimen 3 during the Treatment Period. Receives: Drug: Bimekizumab |
| Placebo Group | Placebo comparator | Subjects randomized to this arm will receive placebo during the Initial Treatment Period and bimekizumab during the Maintenance Treatment Period. Receives: Drug: Bimekizumab; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 16
Secondary outcomes (7)
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.
Measured: Week 16
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.
Measured: Baseline, Week 16
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.
Measured: Baseline, Week 16
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.
Measured: Week 16
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).
Measured: 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. 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).
Measured: 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 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.
Measured: From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start19 Feb 2020
- Primary completion7 Apr 2022
- Study completion19 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242446
- Sponsor's protocol ID
- HS0003
- Other IDs
- 2019-002550-23, 2019
- Acronym
- BE HEARD I
- Status last verified
- Aug 2026
- First submitted
- 23 Jan 2020
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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 pre-specified 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.
Publications
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.
PubMed 40172122Ingram 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.
PubMed 40153232Shi 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.
PubMed 40652434Ingram 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.
PubMed 41107641Tzellos 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.
PubMed 41689425Sayed 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.
PubMed 41248770Aleshin MA, Tran T, Pansar I, Shang A, Friesen D, Kimball AB. Residual Burden in Adalimumab-Treated Patients with Hidradenitis Suppurativa: An Observational Cohort Study Based on Insurance Claims in the USA. Drugs Real World Outcomes. 2026 Jul 29. doi: 10.1007/s40801-026-00564-8. Online ahead of print.
PubMed 42525209Daveluy S, Gottlieb AB, Augustin M, Lev-Tov H, Szepietowski JC, Horvath B, Porter ML, Hayama K, Lambert J, Tilt N, Lukowski B, Thorlacius L. Association Between Bimekizumab's Clinical Response and Patient-Reported Benefits on Health-Related Quality of Life: Results from BE HEARD I and II. Dermatol Ther (Heidelb). 2026 Jul;16(7):3315-3329. doi: 10.1007/s13555-026-01790-2. Epub 2026 Jun 5.
PubMed 42247110Kimball 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.
PubMed 38795716