Studie k testování dlouhodobé léčby bimekizumabem u účastníků studie se středně těžkou až těžkou hidradenitis suppurativa (BE HEARD EXT)
Fáze 3, otevřená, paralelní skupinová, multicentrická, rozšiřující studie hodnotící dlouhodobou léčbu bimekizumabem u účastníků studie se středně těžkou až těžkou 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)
Přehled studie
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Campbelltown, Austrálie
- Hs0005 30015
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Carlton, Austrálie
- Hs0005 30016
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East Melbourne, Austrálie
- Hs0005 30011
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Kogarah, Austrálie
- Hs0005 30017
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Parkville, Austrálie
- Hs0005 30018
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St Leonards, Austrálie
- Hs0005 30014
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Westmead, Austrálie
- Hs0005 30009
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Woolloongabba, Austrálie
- Hs0005 30012
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Leuven, Belgie
- Hs0005 40002
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Woluwe-Saint-Lambert, Belgie
- Hs0005 40121
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Pleven, Bulharsko
- Hs0005 40313
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Sofia, Bulharsko
- Hs0005 40284
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Sofia, Bulharsko
- Hs0005 40311
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Sofia, Bulharsko
- Hs0005 40314
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Sofia, Bulharsko
- Hs0005 40315
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Stara Zagora, Bulharsko
- Hs0005 40353
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Amiens, Francie
- Hs0005 40197
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Antony, Francie
- Hs0005 40245
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Auxerre, Francie
- Hs0005 40321
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La Rochelle, Francie
- Hs0005 40320
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Le Mans, Francie
- Hs0005 40355
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Lyon, Francie
- Hs0005 40247
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Marseille, Francie
- Hs0005 40130
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Nice, Francie
- Hs0005 40132
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Reims, Francie
- Hs0005 40404
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Rouen, Francie
- Hs0005 40318
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Saint-Etienne, Francie
- Hs0005 40403
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Saint-Mandé, Francie
- Hs0005 40246
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Toulon, Francie
- Hs0005 40285
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Toulouse, Francie
- Hs0005 40286
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Breda, Holandsko
- Hs0005 40351
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Groningen, Holandsko
- Hs0005 40292
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Rotterdam, Holandsko
- Hs0005 40264
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Dublin, Irsko
- Hs0005 40344
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Catania, Itálie
- Hs0005 40261
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Roma, Itálie
- Hs0005 40263
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Rozzano, Itálie
- Hs0005 40258
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Torino, Itálie
- Hs0005 40330
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Bunkyō City, Japonsko
- Hs0005 20196
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Fukuoka, Japonsko
- Hs0005 20144
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Kagoshima, Japonsko
- Hs0005 20195
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Kurume, Japonsko
- Hs0005 20170
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Kyoto, Japonsko
- Hs0005 20190
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Nagoya, Japonsko
- Hs0005 20033
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Nakagami-gun, Japonsko
- Hs0005 20152
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Nishinomiya, Japonsko
- Hs0005 20178
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Obihiro, Japonsko
- Hs0005 20153
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Osaka, Japonsko
- Hs0005 20037
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Sapporo, Japonsko
- Hs0005 20154
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Sendai, Japonsko
- Hs0005 20171
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tabashi City, Japonsko
- Hs0005 20043
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Barrie, Kanada
- Hs0005 50233
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Cobourg, Kanada
- Hs0005 50172
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Edmonton, Kanada
- Hs0005 50135
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London, Kanada
- Hs0005 50174
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Richmond Hill, Kanada
- Hs0005 50190
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Saskatoon, Kanada
- Hs0005 50192
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Surrey, Kanada
- Hs0005 50133
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Waterloo, Kanada
- Hs0005 50134
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Winnipeg, Kanada
- Hs0005 50136
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Debrecen, Maďarsko
- Hs0005 40254
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Berlin, Německo
- Hs0005 40325
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Berlin, Německo
- Hs0005 40326
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Bochum, Německo
- Hs0005 40248
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Bonn, Německo
- Hs0005 40327
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Darmstadt, Německo
- Hs0005 40288
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Dresden, Německo
- Hs0005 40324
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Dresden, Německo
- Hs0005 40356
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Frankfurt am Main, Německo
- Hs0005 40287
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Hamburg, Německo
- Hs0005 40142
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Hanover, Německo
- Hs0005 40328
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Kiel, Německo
- Hs0005 40249
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Lübeck, Německo
- Hs0005 40250
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Mainz, Německo
- Hs0005 40174
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München, Německo
- Hs0005 40323
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Münster, Německo
- Hs0005 40177
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Lodz, Polsko
- Hs0005 40347
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Rzeszów, Polsko
- Hs0005 40293
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Warsaw, Polsko
- Hs0005 40335
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Wroclaw, Polsko
- Hs0005 40095
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Wroclaw, Polsko
- Hs0005 40333
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Wroclaw, Polsko
- Hs0005 40334
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Leeds, Spojené království
- Hs0005 40339
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Alabama
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Birmingham, Alabama, Spojené státy, 35249
- Hs0005 50140
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Arizona
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Phoenix, Arizona, Spojené státy, 85006
- Hs0005 50175
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California
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Fountain Valley, California, Spojené státy, 92708
- Hs0005 50162
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Los Angeles, California, Spojené státy, 90045
- Hs0005 50161
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San Diego, California, Spojené státy, 92123
- Hs0005 50220
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Thousand Oaks, California, Spojené státy, 91320
- Hs0005 50196
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Florida
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Miami, Florida, Spojené státy, 33136
- Hs0005 50199
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North Miami Beach, Florida, Spojené státy, 33162-4708
- Hs0005 50205
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Orange Park, Florida, Spojené státy, 32073
- Hs0005 50152
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Pembroke Pines, Florida, Spojené státy, 33028
- Hs0005 50184
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Georgia
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Sandy Springs, Georgia, Spojené státy, 30329
- Hs0005 50193
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Watkinsville, Georgia, Spojené státy, 30677
- Hs0005 50280
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Indiana
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Plainfield, Indiana, Spojené státy, 46168
- Hs0005 50234
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Kentucky
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Murray, Kentucky, Spojené státy, 42071
- Hs0005 50425
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Massachusetts
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Beverly, Massachusetts, Spojené státy, 01915
- Hs0005 50198
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Boston, Massachusetts, Spojené státy, 02215
- Hs0005 50146
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Michigan
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Clarkston, Michigan, Spojené státy, 48346
- Hs0005 50178
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Missouri
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St Louis, Missouri, Spojené státy, 63110
- Hs0005 50105
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Nebraska
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Omaha, Nebraska, Spojené státy, 68144
- Hs0005 50194
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Nevada
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Las Vegas, Nevada, Spojené státy, 89148
- Hs0005 50208
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New Hampshire
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Newington, New Hampshire, Spojené státy, 03801
- Hs0005 50159
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New Jersey
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East Windsor, New Jersey, Spojené státy, 08520
- Hs0005 50137
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Verona, New Jersey, Spojené státy, 07044
- Hs0005 50200
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87102
- Hs0005 50237
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New York
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New York, New York, Spojené státy, 10003
- Hs0005 50235
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North Carolina
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Chapel Hill, North Carolina, Spojené státy, 27516
- Hs0005 50151
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Durham, North Carolina, Spojené státy, 27710
- Hs0005 50211
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Winston-Salem, North Carolina, Spojené státy, 27157
- Hs0005 50179
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Ohio
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Cincinnati, Ohio, Spojené státy, 45219
- Hs0005 50177
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Columbus, Ohio, Spojené státy, 43213
- Hs0005 50138
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Columbus, Ohio, Spojené státy, 43230
- Hs0005 50145
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Fairborn, Ohio, Spojené státy, 45324
- Hs0005 50202
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Oklahoma
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Tulsa, Oklahoma, Spojené státy, 74137
- Hs0005 50204
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Pennsylvania
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Hershey, Pennsylvania, Spojené státy, 17033
- Hs0005 50147
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Rhode Island
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Johnston, Rhode Island, Spojené státy, 02919
- Hs0005 50008
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Providence, Rhode Island, Spojené státy, 02903
- Hs0005 50180
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South Carolina
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Charleston, South Carolina, Spojené státy, 29425
- Hs0005 50084
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Greenville, South Carolina, Spojené státy, 29615
- Hs0005 50236
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Tennessee
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Nashville, Tennessee, Spojené státy, 37215
- Hs0005 50142
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Texas
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Arlington, Texas, Spojené státy, 76011
- Hs0005 50201
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Pflugerville, Texas, Spojené státy, 78660
- Hs0005 50148
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Utah
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Salt Lake City, Utah, Spojené státy, 84107
- Hs0005 50141
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Washington
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Seattle, Washington, Spojené státy, 98101
- Hs0005 50270
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Antalya, Turecko (Türkiye)
- Hs0005 40270
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Gaziantep, Turecko (Türkiye)
- Hs0005 40273
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Istanbul, Turecko (Türkiye)
- Hs0005 40272
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Izmir, Turecko (Türkiye)
- Hs0005 40271
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Prague, Česko
- Hs0005 40063
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Prague, Česko
- Hs0005 40194
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Athens, Řecko
- Hs0005 40251
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Efkarpia, Řecko
- Hs0005 40252
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Badalona, Španělsko
- Hs0005 40266
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Barcelona, Španělsko
- Hs0005 40159
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Barcelona, Španělsko
- Hs0005 40267
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Granada, Španělsko
- Hs0005 40298
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Las Palmas de Gran Canaria, Španělsko
- Hs0005 40294
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Madrid, Španělsko
- Hs0005 40268
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Manises, Španělsko
- Hs0005 40297
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Pontevedra, Španělsko
- Hs0005 40295
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Seville, Španělsko
- Hs0005 40049
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Valencia, Španělsko
- Hs0005 40230
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Geneva, Švýcarsko
- Hs0005 40406
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
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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
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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
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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)
Exclusion Criteria:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Bimekizumab dosing regimen 1
Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the open-label extension period. |
Subjects will receive bimekizumab at pre-specified time-points.
Ostatní jména:
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Experimentální: Bimekizumab dosing regimen 2
Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the open-label extension period. |
Subjects will receive bimekizumab at pre-specified time-points.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
Časové okno: From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
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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)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of participants with treatment-emergent serious adverse events (SAEs) during the study
Časové okno: From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
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A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:
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From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
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Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study
Časové okno: From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
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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. |
From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
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Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Časové okno: 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
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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. |
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
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Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Časové okno: 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
|
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. |
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
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Percentage of participants with Flare
Časové okno: 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
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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. |
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
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Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) Response for Worst Pain
Časové okno: 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
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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. |
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
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Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score
Časové okno: 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
|
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. |
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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: UCB Cares, 001 844 599 2273
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HS0005
- 2020-004179-42 (Číslo EudraCT)
- U1111-1307-6132 (Jiný identifikátor: World Health Organization (WHO))
- 2024-511035-10 (Identifikátor registru: EU Clinical Trials)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Časový rámec sdílení IPD
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.
Kritéria přístupu pro sdílení IPD
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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .