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Hidradenitis SuppurativaPhase 3BE HEARD IINCT04242498

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 91 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
509 participants
Where
91 sitesin 14 countries
Study dates
2 Mar 2020to 28 Sep 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 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

91 sites in 14 countries.

91 sites in 14 countries

United States24 sites

  • Hs0004 50237

    Albuquerque, New Mexico, 87106

  • Hs0004 50178

    Clarkston, Michigan, 48346

  • Hs0004 50145

    Columbus, Ohio, 43230

  • Hs0004 50211

    Durham, North Carolina, 27710

  • Hs0004 50202

    Fairborn, Ohio, 45324

  • Hs0004 50162

    Fountain Valley, California, 92708

  • Hs0004 50236

    Greenville, South Carolina, 29615

  • Hs0004 50197

    Henderson, Nevada, 89052

  • Hs0004 50084

    Johns Island, South Carolina, 29425

  • Hs0004 50199

    Miami, Florida, 33125

  • Hs0004 50152

    Orange Park, Florida, 32073

  • Hs0004 50144

    Orlando, Florida, 38219

  • Hs0004 50184

    Pembroke Pines, Florida, 33028

  • Hs0004 50148

    Pflugerville, Texas, 78660

  • Hs0004 50150

    Philadelphia, Pennsylvania, 19103

  • Hs0004 50234

    Plainfield, Indiana, 46168

  • Hs0004 50159

    Portsmouth, New Hampshire, 03801

  • Hs0004 50193

    Sandy Springs, Georgia, 30328

  • Hs0004 50223

    Savannah, Georgia, 31419

  • Hs0004 50164

    Skokie, Illinois, 60077

  • Hs0004 50105

    St Louis, Missouri, 63110

  • Hs0004 50196

    Thousand Oaks, California, 91320

  • Hs0004 50200

    Verona, New Jersey, 07044

  • Hs0004 50179

    Winston-Salem, North Carolina, 27104

Other trials in United States

Japan13 sites

  • Hs0004 20196

    Bunkyō City

  • Hs0004 20144

    Fukuoka

  • Hs0004 20195

    Kagoshima

  • Hs0004 20170

    Kurume

  • Hs0004 20190

    Kyoto

  • Hs0004 20033

    Nagoya

  • Hs0004 20152

    Nakagami-gun

  • Hs0004 20178

    Nishinomiya

  • Hs0004 20153

    Obihiro

  • Hs0004 20037

    Osaka

  • Hs0004 20154

    Sapporo

  • Hs0004 20171

    Sendai

  • Hs0004 20043

    tabashi City

Other trials in Japan

France9 sites

  • Hs0004 40245

    Antony

  • Hs0004 40321

    Auxerre

  • Hs0004 40129

    Bordeaux

  • Hs0004 40320

    La Rochelle

  • Hs0004 40247

    Lyon

  • Hs0004 40130

    Marseille

  • Hs0004 40404

    Reims

  • Hs0004 40403

    Saint-Etienne

  • Hs0004 40286

    Toulouse

Other trials in France

Germany8 sites

  • Hs0004 40289

    Berlin

  • Hs0004 40326

    Berlin

  • Hs0004 40322

    Dessau

  • Hs0004 40356

    Dresden

  • Hs0004 40287

    Frankfurt am Main

  • Hs0004 40142

    Hamburg

  • Hs0004 40328

    Hanover

  • Hs0004 40250

    Lübeck

Other trials in Germany

Bulgaria6 sites

  • Hs0004 40313

    Pleven

  • Hs0004 40284

    Sofia

  • Hs0004 40311

    Sofia

  • Hs0004 40314

    Sofia

  • Hs0004 40315

    Sofia

  • Hs0004 40353

    Stara Zagora

Other trials in Bulgaria

Canada6 sites

  • Hs0004 50172

    Cobourg

  • Hs0004 50135

    Edmonton

  • Hs0004 50174

    London

  • Hs0004 50189

    St. John's

  • Hs0004 50134

    Waterloo

  • Hs0004 50136

    Winnipeg

Other trials in Canada

Poland6 sites

  • Hs0004 40347

    Lodz

  • Hs0004 40293

    Rzeszów

  • Hs0004 40335

    Warsaw

  • Hs0004 40095

    Wroclaw

  • Hs0004 40333

    Wroclaw

  • Hs0004 40334

    Wroclaw

Other trials in Poland

Spain6 sites

  • Hs0004 40159

    Barcelona

  • Hs0004 40267

    Barcelona

  • Hs0004 40298

    Granada

  • Hs0004 40268

    Madrid

  • Hs0004 40297

    Manises

  • Hs0004 40101

    Sabadell

Other trials in Spain

United Kingdom5 sites

  • Hs0004 40300

    Cardiff

  • Hs0004 40339

    Leeds

  • Hs0004 40113

    London

  • Hs0004 40240

    Newcastle upon Tyne

  • Hs0004 40338

    Northampton

Other trials in United Kingdom

Australia3 sites

  • Hs0004 30018

    Parkville

  • Hs0004 30014

    St Leonards

  • Hs0004 30009

    Westmead

Other trials in Australia

Czechia2 sites

  • Hs0004 40063

    Prague

  • Hs0004 40194

    Prague

Other trials in Czechia

Hungary1 site

  • Hs0004 40254

    Debrecen

Other trials in Hungary

Ireland1 site

  • Hs0004 40344

    Dublin

Other trials in Ireland

Israel1 site

  • Hs0004 20090

    Afula

Other trials in Israel

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)

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 groups in NCT04242498
Study groupRoleWhat they receive
Bimekizumab dosing regimen 1ExperimentalSubjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the Treatment Period.
Receives: Drug: Bimekizumab
Bimekizumab dosing regimen 2ExperimentalSubjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the Treatment Period.
Receives: Drug: Bimekizumab
Bimekizumab dosing regimen 3ExperimentalSubjects participating in the study will receive assigned bimekizumab dosing regimen 3 during the Treatment Period.
Receives: Drug: Bimekizumab
Placebo GroupPlacebo comparatorSubjects 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.

  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.

    Measured: Week 16

Secondary outcomes (8)

  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.

    Measured: Week 16

  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.

    Measured: From Baseline to Week 16

  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.

    Measured: Baseline, Week 16

  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.

    Measured: Baseline, Week 16

  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.

    Measured: Week 16

  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).

    Measured: From Baseline (Day 1) until Safety Follow-Up (up to Week 71)

  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).

    Measured: From Baseline (Day 1) until Safety Follow-Up (up to Week 71)

  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.

    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.

  1. First posted27 Jan 2020
  2. Study start2 Mar 2020
  3. Primary completion9 Nov 2021
  4. Study completion28 Sep 2022

Resources

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
509 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04242498
Sponsor's protocol ID
HS0004
Other IDs
2019-002551-42, 2019
Acronym
BE HEARD II
Status last verified
Sep 2026
First submitted
23 Jan 2020
Last updated
26 Oct 2026
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 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.

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 40172122

  • Ingram 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 40153232

  • Shi 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 40652434

  • Ingram 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 41107641

  • Tzellos 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 41689425

  • Sayed 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 41248770

  • Aleshin 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 42525209

  • Chovatiya R, Alavi A, Miyagawa T, Turchin I, Tzellos T, van der Zee HH, Crater C, Lukowski B, Tilt N, Zouboulis CC. Bimekizumab 2-year efficacy by hidradenitis suppurativa duration: BE HEARD EXT results. J Eur Acad Dermatol Venereol. 2026 Jul 22. doi: 10.1111/jdv.70631. Online ahead of print. No abstract available.

    PubMed 42482599

  • Daveluy 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 42247110

  • Kimball 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bimekizumab in people with Hidradenitis Suppurativa, run by UCB Biopharma SRL at 91 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States, Japan, France, Germany, Bulgaria and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04242498, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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