A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
NCT ID: NCT04901195
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
658 participants
INTERVENTIONAL
2021-05-27
2026-07-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bimekizumab dosing regimen 1
Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the open-label extension period.
Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Bimekizumab dosing regimen 2
Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the open-label extension period.
Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Interventions
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Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
1. Not a woman of childbearing potential (WOCBP) OR
2. 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)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273
Locations
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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 20152
Ginowan, , Japan
Hs0005 20043
Itabashi-ku, , Japan
Hs0005 20195
Kagoshima, , Japan
Hs0005 20170
Kurume, , Japan
Hs0005 20190
Kyoto, , Japan
Hs0005 20033
Nagoya, , 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
Hs0005 50140
Birmingham, Alabama, United States
Hs0005 50175
Phoenix, Arizona, United States
Hs0005 50162
Fountain Valley, California, United States
Hs0005 50161
Los Angeles, California, United States
Hs0005 50220
San Diego, California, United States
Hs0005 50196
Thousand Oaks, California, United States
Hs0005 50199
Miami, Florida, United States
Hs0005 50205
North Miami Beach, Florida, United States
Hs0005 50152
Orange Park, Florida, United States
Hs0005 50184
Pembroke Pines, Florida, United States
Hs0005 50141
Tampa, Florida, United States
Hs0005 50193
Sandy Springs, Georgia, United States
Hs0005 50280
Watkinsville, Georgia, United States
Hs0005 50234
Plainfield, Indiana, United States
Hs0005 50425
Murray, Kentucky, United States
Hs0005 50198
Beverly, Massachusetts, United States
Hs0005 50146
Boston, Massachusetts, United States
Hs0005 50178
Clarkston, Michigan, United States
Hs0005 50105
St Louis, Missouri, United States
Hs0005 50194
Omaha, Nebraska, United States
Hs0005 50208
Las Vegas, Nevada, United States
Hs0005 50159
Portsmouth, New Hampshire, United States
Hs0005 50137
East Windsor, New Jersey, United States
Hs0005 50200
Verona, New Jersey, United States
Hs0005 50237
Albuquerque, New Mexico, United States
Hs0005 50235
New York, New York, United States
Hs0005 50151
Chapel Hill, North Carolina, United States
Hs0005 50211
Durham, North Carolina, United States
Hs0005 50179
Winston-Salem, North Carolina, United States
Hs0005 50177
Cincinnati, Ohio, United States
Hs0005 50138
Columbus, Ohio, United States
Hs0005 50145
Columbus, Ohio, United States
Hs0005 50202
Fairborn, Ohio, United States
Hs0005 50204
Tulsa, Oklahoma, United States
Hs0005 50147
Hershey, Pennsylvania, United States
Hs0005 50008
Johnston, Rhode Island, United States
Hs0005 50180
Providence, Rhode Island, United States
Hs0005 50084
Charleston, South Carolina, United States
Hs0005 50236
Greenville, South Carolina, United States
Hs0005 50142
Nashville, Tennessee, United States
Hs0005 50201
Arlington, Texas, United States
Hs0005 50148
Pflugerville, Texas, United States
Hs0005 50270
Seattle, Washington, 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
Countries
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References
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Skrzypczak 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.
Other Identifiers
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2020-004179-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1307-6132
Identifier Type: OTHER
Identifier Source: secondary_id
2024-511035-10
Identifier Type: REGISTRY
Identifier Source: secondary_id
HS0005
Identifier Type: -
Identifier Source: org_study_id