Hidradenitis SuppurativaPhase 3BE HEARD EXTNCT04901195
A Study to Test the Long-term Treatment 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 145 sites in 19 countries.
Trial summary
The purpose of the study is to evaluate the safety of long-term therapy 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?
- No, everyone receives an active treatment
- How many people
- 658 participants
- Where
- 145 sitesin 19 countries
- Study dates
- 27 May 2021to 22 Jul 2026
- 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
- Study participant has completed the Maintenance Treatment Period through Week 48 in HS0003 (NCT04242446) or HS0004 (NCT04242498), was eligible to receive bimekizumab at the time of completing the feeder study, and did not meet any withdrawal criteria of the feeder study
- Study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the Investigator
- 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 open-label extension period and for at least 20 weeks after the final dose of investigational medicinal product (IMP)
Who cannot join
- Female study participant 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)
- Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments Note: For any study participant with an ongoing serious adverse event (SAE) from HS0003 (NCT04242446) or HS0004 (NCT04242498), or any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry or a history of serious infections in HS0003 or HS0004, the Medical Monitor must be consulted prior to the study participant's entry into HS0005, although the decision on whether to enroll the participant remains with the Investigator.
- Study participant has a positive or indeterminate interferon-gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated
- Study participant has ongoing or planned use of prohibited hidradenitis suppurativa (HS) or non-HS treatment
- Study participant plans to participate in another study of a medicinal product or device under investigation during this study
Trial locations and contacts
145 sites in 19 countries.
145 sites in 19 countries
United States43 sites
Hs0005 50237
Albuquerque, New Mexico, 87102
Hs0005 50201
Arlington, Texas, 76011
Hs0005 50198
Beverly, Massachusetts, 01915
Hs0005 50140
Birmingham, Alabama, 35249
Hs0005 50146
Boston, Massachusetts, 02215
Hs0005 50151
Chapel Hill, North Carolina, 27516
Hs0005 50084
Charleston, South Carolina, 29425
Hs0005 50177
Cincinnati, Ohio, 45219
Hs0005 50178
Clarkston, Michigan, 48346
Hs0005 50138
Columbus, Ohio, 43213
Hs0005 50145
Columbus, Ohio, 43230
Hs0005 50211
Durham, North Carolina, 27710
Hs0005 50137
East Windsor, New Jersey, 08520
Hs0005 50202
Fairborn, Ohio, 45324
Hs0005 50162
Fountain Valley, California, 92708
Hs0005 50236
Greenville, South Carolina, 29615
Hs0005 50147
Hershey, Pennsylvania, 17033
Hs0005 50008
Johnston, Rhode Island, 02919
Hs0005 50208
Las Vegas, Nevada, 89148
Hs0005 50161
Los Angeles, California, 90045
Hs0005 50199
Miami, Florida, 33136
Hs0005 50425
Murray, Kentucky, 42071
Hs0005 50142
Nashville, Tennessee, 37215
Hs0005 50235
New York, New York, 10003
Hs0005 50159
Newington, New Hampshire, 03801
Hs0005 50205
North Miami Beach, Florida, 33162-4708
Hs0005 50194
Omaha, Nebraska, 68144
Hs0005 50152
Orange Park, Florida, 32073
Hs0005 50184
Pembroke Pines, Florida, 33028
Hs0005 50148
Pflugerville, Texas, 78660
Hs0005 50175
Phoenix, Arizona, 85006
Hs0005 50234
Plainfield, Indiana, 46168
Hs0005 50180
Providence, Rhode Island, 02903
Hs0005 50141
Salt Lake City, Utah, 84107
Hs0005 50220
San Diego, California, 92123
Hs0005 50193
Sandy Springs, Georgia, 30329
Hs0005 50270
Seattle, Washington, 98101
Hs0005 50105
St Louis, Missouri, 63110
Hs0005 50196
Thousand Oaks, California, 91320
Hs0005 50204
Tulsa, Oklahoma, 74137
Hs0005 50200
Verona, New Jersey, 07044
Hs0005 50280
Watkinsville, Georgia, 30677
Hs0005 50179
Winston-Salem, North Carolina, 27157
Germany15 sites
Hs0005 40325
Berlin
Hs0005 40326
Berlin
Hs0005 40248
Bochum
Hs0005 40327
Bonn
Hs0005 40288
Darmstadt
Hs0005 40324
Dresden
Hs0005 40356
Dresden
Hs0005 40287
Frankfurt am Main
Hs0005 40142
Hamburg
Hs0005 40328
Hanover
Hs0005 40249
Kiel
Hs0005 40250
Lübeck
Hs0005 40174
Mainz
Hs0005 40323
München
Hs0005 40177
Münster
France14 sites
Hs0005 40197
Amiens
Hs0005 40245
Antony
Hs0005 40321
Auxerre
Hs0005 40320
La Rochelle
Hs0005 40355
Le Mans
Hs0005 40247
Lyon
Hs0005 40130
Marseille
Hs0005 40132
Nice
Hs0005 40404
Reims
Hs0005 40318
Rouen
Hs0005 40403
Saint-Etienne
Hs0005 40246
Saint-Mandé
Hs0005 40285
Toulon
Hs0005 40286
Toulouse
Japan13 sites
Hs0005 20196
Bunkyō City
Hs0005 20144
Fukuoka
Hs0005 20043
Itabashi-ku
Hs0005 20195
Kagoshima
Hs0005 20170
Kurume
Hs0005 20190
Kyoto
Hs0005 20033
Nagoya
Hs0005 20152
Nakagami-gun
Hs0005 20178
Nishinomiya
Hs0005 20153
Obihiro
Hs0005 20037
Osaka
Hs0005 20154
Sapporo
Hs0005 20171
Sendai
Spain10 sites
Hs0005 40266
Badalona
Hs0005 40159
Barcelona
Hs0005 40267
Barcelona
Hs0005 40298
Granada
Hs0005 40294
Las Palmas de Gran Canaria
Hs0005 40268
Madrid
Hs0005 40297
Manises
Hs0005 40295
Pontevedra
Hs0005 40049
Seville
Hs0005 40230
Valencia
Canada9 sites
Hs0005 50233
Barrie
Hs0005 50172
Cobourg
Hs0005 50135
Edmonton
Hs0005 50174
London
Hs0005 50190
Richmond Hill
Hs0005 50192
Saskatoon
Hs0005 50133
Surrey
Hs0005 50134
Waterloo
Hs0005 50136
Winnipeg
Australia8 sites
Hs0005 30015
Campbelltown
Hs0005 30016
Carlton
Hs0005 30011
East Melbourne
Hs0005 30017
Kogarah
Hs0005 30018
Parkville
Hs0005 30014
St Leonards
Hs0005 30009
Westmead
Hs0005 30012
Woolloongabba
Bulgaria6 sites
Hs0005 40313
Pleven
Hs0005 40284
Sofia
Hs0005 40311
Sofia
Hs0005 40314
Sofia
Hs0005 40315
Sofia
Hs0005 40353
Stara Zagora
Poland6 sites
Hs0005 40347
Lodz
Hs0005 40293
Rzeszów
Hs0005 40335
Warsaw
Hs0005 40095
Wroclaw
Hs0005 40333
Wroclaw
Hs0005 40334
Wroclaw
Italy4 sites
Hs0005 40261
Catania
Hs0005 40263
Roma
Hs0005 40258
Rozzano
Hs0005 40330
Torino
Turkey (Türkiye)4 sites
Hs0005 40270
Antalya
Hs0005 40273
Gaziantep
Hs0005 40272
Istanbul
Hs0005 40271
Izmir
Netherlands3 sites
Hs0005 40351
Breda
Hs0005 40292
Groningen
Hs0005 40264
Rotterdam
About this study
Official title: A Phase 3, Open-Label, Parallel Group, Multicenter, Extension Study Evaluating the Long-Term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
The purpose of the study is to evaluate the safety of long-term therapy of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Bimekizumab
- 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.
| 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 open-label extension period. Receives: Drug: Bimekizumab |
| Bimekizumab dosing regimen 2 | Experimental | Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the open-label extension period. Receives: Drug: Bimekizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
Secondary outcomes (7)
Percentage of participants with treatment-emergent serious adverse events (SAEs) 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
Measured: From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
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.
Measured: From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
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.
Results will be presented individually per week listed under time points.
Measured: Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
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.
Results will be presented individually per week listed under time points.
Measured: Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
Percentage of participants with Flare
Flare is defined as a ≥25 % increase in abscess and inflammatory nodule (AN) count with an absolute increase in AN count of ≥2 relative to Baseline.
Results will be presented individually per week listed under time points.
Measured: Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) Response for Worst Pain
The 4 items on the HSSQ assess the study participant's perception of the core symptoms of HS experienced in the past 7 days - pain, smell or odor, drainage or oozing from HS lesions, and itch on an 11-point numeric rating scale with higher scores indicating higher symptom level.
Results will be presented individually per week listed under time points.
Measured: Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score
The DLQI is a skin disease specific questionnaire aimed at the evaluation of how the disease affects participants health related quality of life (QOL). The DLQI total score ranges from 0 to 30 with higher scores indicating higher skin disease impact on QOL.
Results will be presented individually per week listed under time points.
Measured: Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start27 May 2021
- Primary completion22 Jul 2026
- Study completion22 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 658 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
- NCT04901195
- Sponsor's protocol ID
- HS0005
- Other IDs
- 2020-004179-42, U1111-1307-6132, 2024-511035-10
- Acronym
- BE HEARD EXT
- Status last verified
- Sep 2026
- First submitted
- 20 May 2021
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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
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 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 42525209Chovatiya 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 42482599Skrzypczak T, Skrzypczak A, Matusiak L, Szepietowski JC. An evaluation of bimekizumab for the treatment of hidradenitis suppurativa. Expert Opin Biol Ther. 2025 Aug;25(8):811-819. doi: 10.1080/14712598.2025.2522119. Epub 2025 Jun 21.
PubMed 40524676