A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
BE HEARD EXT
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
4 other identifiers
interventional
658
19 countries
145
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2021
Longer than P75 for phase_3
145 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
May 20, 2021
CompletedFirst Posted
Study publicly available on registry
May 25, 2021
CompletedStudy Start
First participant enrolled
May 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 28, 2026
May 6, 2026
May 1, 2026
5.2 years
May 20, 2021
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 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
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
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)
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)
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
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
- +2 more secondary outcomes
Study Arms (2)
Bimekizumab dosing regimen 1
EXPERIMENTALSubjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the open-label extension period.
Bimekizumab dosing regimen 2
EXPERIMENTALSubjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the open-label extension period.
Interventions
Subjects will receive bimekizumab at pre-specified time-points.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (145)
Hs0005 50140
Birmingham, Alabama, 35249, United States
Hs0005 50175
Phoenix, Arizona, 85006, United States
Hs0005 50162
Fountain Valley, California, 92708, United States
Hs0005 50161
Los Angeles, California, 90045, United States
Hs0005 50220
San Diego, California, 92123, United States
Hs0005 50196
Thousand Oaks, California, 91320, United States
Hs0005 50199
Miami, Florida, 33136, United States
Hs0005 50205
North Miami Beach, Florida, 33162-4708, United States
Hs0005 50152
Orange Park, Florida, 32073, United States
Hs0005 50184
Pembroke Pines, Florida, 33028, United States
Hs0005 50193
Sandy Springs, Georgia, 30329, United States
Hs0005 50280
Watkinsville, Georgia, 30677, United States
Hs0005 50234
Plainfield, Indiana, 46168, United States
Hs0005 50425
Murray, Kentucky, 42071, United States
Hs0005 50198
Beverly, Massachusetts, 01915, United States
Hs0005 50146
Boston, Massachusetts, 02215, United States
Hs0005 50178
Clarkston, Michigan, 48346, United States
Hs0005 50105
St Louis, Missouri, 63110, United States
Hs0005 50194
Omaha, Nebraska, 68144, United States
Hs0005 50208
Las Vegas, Nevada, 89148, United States
Hs0005 50159
Newington, New Hampshire, 03801, United States
Hs0005 50137
East Windsor, New Jersey, 08520, United States
Hs0005 50200
Verona, New Jersey, 07044, United States
Hs0005 50237
Albuquerque, New Mexico, 87102, United States
Hs0005 50235
New York, New York, 10003, United States
Hs0005 50151
Chapel Hill, North Carolina, 27516, United States
Hs0005 50211
Durham, North Carolina, 27710, United States
Hs0005 50179
Winston-Salem, North Carolina, 27157, United States
Hs0005 50177
Cincinnati, Ohio, 45219, United States
Hs0005 50138
Columbus, Ohio, 43213, United States
Hs0005 50145
Columbus, Ohio, 43230, United States
Hs0005 50202
Fairborn, Ohio, 45324, United States
Hs0005 50204
Tulsa, Oklahoma, 74137, United States
Hs0005 50147
Hershey, Pennsylvania, 17033, United States
Hs0005 50008
Johnston, Rhode Island, 02919, United States
Hs0005 50180
Providence, Rhode Island, 02903, United States
Hs0005 50084
Charleston, South Carolina, 29425, United States
Hs0005 50236
Greenville, South Carolina, 29615, United States
Hs0005 50142
Nashville, Tennessee, 37215, United States
Hs0005 50201
Arlington, Texas, 76011, United States
Hs0005 50148
Pflugerville, Texas, 78660, United States
Hs0005 50141
Salt Lake City, Utah, 84107, United States
Hs0005 50270
Seattle, Washington, 98101, United States
Hs0005 30015
Campbelltown, Australia
Hs0005 30016
Carlton, Australia
Hs0005 30011
East Melbourne, Australia
Hs0005 30017
Kogarah, Australia
Hs0005 30018
Parkville, Australia
Hs0005 30014
St Leonards, Australia
Hs0005 30009
Westmead, Australia
Hs0005 30012
Woolloongabba, Australia
Hs0005 40002
Leuven, Belgium
Hs0005 40121
Woluwe-Saint-Lambert, Belgium
Hs0005 40313
Pleven, Bulgaria
Hs0005 40284
Sofia, Bulgaria
Hs0005 40311
Sofia, Bulgaria
Hs0005 40314
Sofia, Bulgaria
Hs0005 40315
Sofia, Bulgaria
Hs0005 40353
Stara Zagora, Bulgaria
Hs0005 50233
Barrie, Canada
Hs0005 50172
Cobourg, Canada
Hs0005 50135
Edmonton, Canada
Hs0005 50174
London, Canada
Hs0005 50190
Richmond Hill, Canada
Hs0005 50192
Saskatoon, Canada
Hs0005 50133
Surrey, Canada
Hs0005 50134
Waterloo, Canada
Hs0005 50136
Winnipeg, Canada
Hs0005 40063
Prague, Czechia
Hs0005 40194
Prague, Czechia
Hs0005 40197
Amiens, France
Hs0005 40245
Antony, France
Hs0005 40321
Auxerre, France
Hs0005 40320
La Rochelle, France
Hs0005 40355
Le Mans, France
Hs0005 40247
Lyon, France
Hs0005 40130
Marseille, France
Hs0005 40132
Nice, France
Hs0005 40404
Reims, France
Hs0005 40318
Rouen, France
Hs0005 40403
Saint-Etienne, France
Hs0005 40246
Saint-Mandé, France
Hs0005 40285
Toulon, France
Hs0005 40286
Toulouse, France
Hs0005 40325
Berlin, Germany
Hs0005 40326
Berlin, Germany
Hs0005 40248
Bochum, Germany
Hs0005 40327
Bonn, Germany
Hs0005 40288
Darmstadt, Germany
Hs0005 40324
Dresden, Germany
Hs0005 40356
Dresden, Germany
Hs0005 40287
Frankfurt am Main, Germany
Hs0005 40142
Hamburg, Germany
Hs0005 40328
Hanover, Germany
Hs0005 40249
Kiel, Germany
Hs0005 40250
Lübeck, Germany
Hs0005 40174
Mainz, Germany
Hs0005 40323
München, Germany
Hs0005 40177
Münster, Germany
Hs0005 40251
Athens, Greece
Hs0005 40252
Efkarpia, Greece
Hs0005 40254
Debrecen, Hungary
Hs0005 40344
Dublin, Ireland
Hs0005 40261
Catania, Italy
Hs0005 40263
Roma, Italy
Hs0005 40258
Rozzano, Italy
Hs0005 40330
Torino, Italy
Hs0005 20196
Bunkyō City, Japan
Hs0005 20144
Fukuoka, Japan
Hs0005 20043
Itabashi-ku, Japan
Hs0005 20195
Kagoshima, Japan
Hs0005 20170
Kurume, Japan
Hs0005 20190
Kyoto, Japan
Hs0005 20033
Nagoya, Japan
Hs0005 20152
Nakagami-gun, Japan
Hs0005 20178
Nishinomiya, Japan
Hs0005 20153
Obihiro, Japan
Hs0005 20037
Osaka, Japan
Hs0005 20154
Sapporo, Japan
Hs0005 20171
Sendai, Japan
Hs0005 40351
Breda, Netherlands
Hs0005 40292
Groningen, Netherlands
Hs0005 40264
Rotterdam, Netherlands
Hs0005 40347
Lodz, Poland
Hs0005 40293
Rzeszów, Poland
Hs0005 40335
Warsaw, Poland
Hs0005 40095
Wroclaw, Poland
Hs0005 40333
Wroclaw, Poland
Hs0005 40334
Wroclaw, Poland
Hs0005 40266
Badalona, Spain
Hs0005 40159
Barcelona, Spain
Hs0005 40267
Barcelona, Spain
Hs0005 40298
Granada, Spain
Hs0005 40294
Las Palmas de Gran Canaria, Spain
Hs0005 40268
Madrid, Spain
Hs0005 40297
Manises, Spain
Hs0005 40295
Pontevedra, Spain
Hs0005 40049
Seville, Spain
Hs0005 40230
Valencia, Spain
Hs0005 40406
Geneva, Switzerland
Hs0005 40270
Antalya, Turkey (Türkiye)
Hs0005 40273
Gaziantep, Turkey (Türkiye)
Hs0005 40272
Istanbul, Turkey (Türkiye)
Hs0005 40271
Izmir, Turkey (Türkiye)
Hs0005 40339
Leeds, United Kingdom
Related Publications (2)
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.
PMID: 41248770RESULTSkrzypczak 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.
PMID: 40524676DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2021
First Posted
May 25, 2021
Study Start
May 27, 2021
Primary Completion (Estimated)
July 28, 2026
Study Completion (Estimated)
July 28, 2026
Last Updated
May 6, 2026
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.