A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
- Registration Number
- NCT04901195
- Lead Sponsor
- UCB Biopharma SRL
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 658
-
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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bimekizumab dosing regimen 1 Bimekizumab Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the open-label extension period. Bimekizumab dosing regimen 2 Bimekizumab Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the open-label extension period.
- Primary Outcome Measures
Name Time Method Percentage of participants with treatment-emergent adverse events (TEAEs) during the study From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196) 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.
- Secondary Outcome Measures
Name Time Method 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) 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 eventsPercentage 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 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.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) 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.
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 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.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 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.Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) Response for Worst Pain 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 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.Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score 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.
Trial Locations
- Locations (145)
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 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 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 40194
🇨🇿Praha 10, Czechia
Hs0005 40063
🇨🇿Praha 5, Czechia
Hs0005 40197
🇫🇷Amiens Cedex, 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 Cedex, France
Hs0005 40246
🇫🇷Saint Mandé, France
Hs0005 40403
🇫🇷Saint-etienne, 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/main, Germany
Hs0005 40142
🇩🇪Hamburg, Germany
Hs0005 40328
🇩🇪Hannover, 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
ðŸ‡ðŸ‡ºDebrecen, Hungary
Hs0005 40344
🇮🇪Dublin 4, Ireland
Hs0005 40261
🇮🇹Catania, Italy
Hs0005 40263
🇮🇹Roma, Italy
Hs0005 40258
🇮🇹Rozzano, Italy
Hs0005 40330
🇮🇹Torino, Italy
Hs0005 20196
🇯🇵Bunkyo-ku, Japan
Hs0005 20144
🇯🇵Fukuoka, Japan
Hs0005 20152
🇯🇵Ginowan City, 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
🇵🇱Rzeszow, Poland
Hs0005 40335
🇵🇱Warszawa, 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
🇪🇸Sevilla, Spain
Hs0005 40230
🇪🇸Valencia, Spain
Hs0005 40406
🇨ðŸ‡Genève, Switzerland
Hs0005 40270
🇹🇷Antalya, Turkey
Hs0005 40273
🇹🇷Gaziantep, Turkey
Hs0005 40272
🇹🇷Istanbul, Turkey
Hs0005 40271
🇹🇷İ̇zmir, Turkey
Hs0005 40339
🇬🇧Leeds, United Kingdom
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
🇺🇸Saint 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 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