Clinical trial NCT04901195: A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Hidradenitis Suppurativa
Keywords: Bimekizumab
UCB4940
HS
Hidradenitis Suppurativa
Acne inversa
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2021-05-25
Enrollment: 658
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: Inclusion Criteria:

* 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:

  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:

* 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

Primary outcomes:
measure: Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
timeFrame: From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
Secondary outcomes:
measure: Percentage of participants with treatment-emergent serious adverse events (SAEs) during the study
timeFrame: From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
measure: Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study
timeFrame: From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
measure: Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
timeFrame: 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
measure: Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
timeFrame: 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
measure: Percentage of participants with Flare
timeFrame: 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
measure: Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) Response for Worst Pain
timeFrame: 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
measure: Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score
timeFrame: 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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Hs0005 50140
state: Alabama
city: Phoenix
country: United States
facility: Hs0005 50175
state: Arizona
city: Fountain Valley
country: United States
facility: Hs0005 50162
state: California
city: Los Angeles
country: United States
facility: Hs0005 50161
state: California
city: San Diego
country: United States
facility: Hs0005 50220
state: California
city: Thousand Oaks
country: United States
facility: Hs0005 50196
state: California
city: Miami
country: United States
facility: Hs0005 50199
state: Florida
city: North Miami Beach
country: United States
facility: Hs0005 50205
state: Florida
city: Orange Park
country: United States
facility: Hs0005 50152
state: Florida
city: Pembroke Pines
country: United States
facility: Hs0005 50184
state: Florida
city: Tampa
country: United States
facility: Hs0005 50141
state: Florida
city: Sandy Springs
country: United States
facility: Hs0005 50193
state: Georgia
city: Watkinsville
country: United States
facility: Hs0005 50280
state: Georgia
city: Plainfield
country: United States
facility: Hs0005 50234
state: Indiana
city: Murray
country: United States
facility: Hs0005 50425
state: Kentucky
city: Beverly
country: United States
facility: Hs0005 50198
state: Massachusetts
city: Boston
country: United States
facility: Hs0005 50146
state: Massachusetts
city: Clarkston
country: United States
facility: Hs0005 50178
state: Michigan
city: Saint Louis
country: United States
facility: Hs0005 50105
state: Missouri
city: Omaha
country: United States
facility: Hs0005 50194
state: Nebraska
city: Las Vegas
country: United States
facility: Hs0005 50208
state: Nevada
city: Portsmouth
country: United States
facility: Hs0005 50159
state: New Hampshire
city: East Windsor
country: United States
facility: Hs0005 50137
state: New Jersey
city: Verona
country: United States
facility: Hs0005 50200
state: New Jersey
city: Albuquerque
country: United States
facility: Hs0005 50237
state: New Mexico
city: New York
country: United States
facility: Hs0005 50235
state: New York
city: Chapel Hill
country: United States
facility: Hs0005 50151
state: North Carolina
city: Durham
country: United States
facility: Hs0005 50211
state: North Carolina
city: Winston-Salem
country: United States
facility: Hs0005 50179
state: North Carolina
city: Cincinnati
country: United States
facility: Hs0005 50177
state: Ohio
city: Columbus
country: United States
facility: Hs0005 50138
state: Ohio
city: Columbus
country: United States
facility: Hs0005 50145
state: Ohio
city: Fairborn
country: United States
facility: Hs0005 50202
state: Ohio
city: Tulsa
country: United States
facility: Hs0005 50204
state: Oklahoma
city: Hershey
country: United States
facility: Hs0005 50147
state: Pennsylvania
city: Johnston
country: United States
facility: Hs0005 50008
state: Rhode Island
city: Providence
country: United States
facility: Hs0005 50180
state: Rhode Island
city: Charleston
country: United States
facility: Hs0005 50084
state: South Carolina
city: Greenville
country: United States
facility: Hs0005 50236
state: South Carolina
city: Nashville
country: United States
facility: Hs0005 50142
state: Tennessee
city: Arlington
country: United States
facility: Hs0005 50201
state: Texas
city: Pflugerville
country: United States
facility: Hs0005 50148
state: Texas
city: Seattle
country: United States
facility: Hs0005 50270
state: Washington
city: Campbelltown
country: Australia
facility: Hs0005 30015
city: Carlton
country: Australia
facility: Hs0005 30016
city: East Melbourne
country: Australia
facility: Hs0005 30011
city: Kogarah
country: Australia
facility: Hs0005 30017
city: Parkville
country: Australia
facility: Hs0005 30018
city: St Leonards
country: Australia
facility: Hs0005 30014
city: Westmead
country: Australia
facility: Hs0005 30009
city: Woolloongabba
country: Australia
facility: Hs0005 30012
city: Leuven
country: Belgium
facility: Hs0005 40002
city: Woluwe-saint-lambert
country: Belgium
facility: Hs0005 40121
city: Pleven
country: Bulgaria
facility: Hs0005 40313
city: Sofia
country: Bulgaria
facility: Hs0005 40284
city: Sofia
country: Bulgaria
facility: Hs0005 40311
city: Sofia
country: Bulgaria
facility: Hs0005 40314
city: Sofia
country: Bulgaria
facility: Hs0005 40315
city: Stara Zagora
country: Bulgaria
facility: Hs0005 40353
city: Barrie
country: Canada
facility: Hs0005 50233
city: Cobourg
country: Canada
facility: Hs0005 50172
city: Edmonton
country: Canada
facility: Hs0005 50135
city: London
country: Canada
facility: Hs0005 50174
city: Richmond Hill
country: Canada
facility: Hs0005 50190
city: Saskatoon
country: Canada
facility: Hs0005 50192
city: Surrey
country: Canada
facility: Hs0005 50133
city: Waterloo
country: Canada
facility: Hs0005 50134
city: Winnipeg
country: Canada
facility: Hs0005 50136
city: Praha 10
country: Czechia
facility: Hs0005 40194
city: Praha 5
country: Czechia
facility: Hs0005 40063
city: Amiens Cedex
country: France
facility: Hs0005 40197
city: Antony
country: France
facility: Hs0005 40245
city: Auxerre
country: France
facility: Hs0005 40321
city: La Rochelle
country: France
facility: Hs0005 40320
city: Le Mans
country: France
facility: Hs0005 40355
city: Lyon
country: France
facility: Hs0005 40247
city: Marseille
country: France
facility: Hs0005 40130
city: Nice
country: France
facility: Hs0005 40132
city: Reims
country: France
facility: Hs0005 40404
city: Rouen Cedex
country: France
facility: Hs0005 40318
city: Saint Mandé
country: France
facility: Hs0005 40246
city: Saint-etienne
country: France
facility: Hs0005 40403
city: Toulon
country: France
facility: Hs0005 40285
city: Toulouse
country: France
facility: Hs0005 40286
city: Berlin
country: Germany
facility: Hs0005 40325
city: Berlin
country: Germany
facility: Hs0005 40326
city: Bochum
country: Germany
facility: Hs0005 40248
city: Bonn
country: Germany
facility: Hs0005 40327
city: Darmstadt
country: Germany
facility: Hs0005 40288
city: Dresden
country: Germany
facility: Hs0005 40324
city: Dresden
country: Germany
facility: Hs0005 40356
city: Frankfurt/main
country: Germany
facility: Hs0005 40287
city: Hamburg
country: Germany
facility: Hs0005 40142
city: Hannover
country: Germany
facility: Hs0005 40328
city: Kiel
country: Germany
facility: Hs0005 40249
city: Lübeck
country: Germany
facility: Hs0005 40250
city: Mainz
country: Germany
facility: Hs0005 40174
city: München
country: Germany
facility: Hs0005 40323
city: Münster
country: Germany
facility: Hs0005 40177
city: Athens
country: Greece
facility: Hs0005 40251
city: Efkarpia
country: Greece
facility: Hs0005 40252
city: Debrecen
country: Hungary
facility: Hs0005 40254
city: Dublin 4
country: Ireland
facility: Hs0005 40344
city: Catania
country: Italy
facility: Hs0005 40261
city: Roma
country: Italy
facility: Hs0005 40263
city: Rozzano
country: Italy
facility: Hs0005 40258
city: Torino
country: Italy
facility: Hs0005 40330
city: Bunkyo-ku
country: Japan
facility: Hs0005 20196
city: Fukuoka
country: Japan
facility: Hs0005 20144
city: Ginowan City
country: Japan
facility: Hs0005 20152
city: Itabashi-ku
country: Japan
facility: Hs0005 20043
city: Kagoshima
country: Japan
facility: Hs0005 20195
city: Kurume
country: Japan
facility: Hs0005 20170
city: Kyoto
country: Japan
facility: Hs0005 20190
city: Nagoya
country: Japan
facility: Hs0005 20033
city: Nishinomiya
country: Japan
facility: Hs0005 20178
city: Obihiro
country: Japan
facility: Hs0005 20153
city: Osaka
country: Japan
facility: Hs0005 20037
city: Sapporo
country: Japan
facility: Hs0005 20154
city: Sendai
country: Japan
facility: Hs0005 20171
city: Breda
country: Netherlands
facility: Hs0005 40351
city: Groningen
country: Netherlands
facility: Hs0005 40292
city: Rotterdam
country: Netherlands
facility: Hs0005 40264
city: Lodz
country: Poland
facility: Hs0005 40347
city: Rzeszow
country: Poland
facility: Hs0005 40293
city: Warszawa
country: Poland
facility: Hs0005 40335
city: Wroclaw
country: Poland
facility: Hs0005 40095
city: Wroclaw
country: Poland
facility: Hs0005 40333
city: Wroclaw
country: Poland
facility: Hs0005 40334
city: Badalona
country: Spain
facility: Hs0005 40266
city: Barcelona
country: Spain
facility: Hs0005 40159
city: Barcelona
country: Spain
facility: Hs0005 40267
city: Granada
country: Spain
facility: Hs0005 40298
city: Las Palmas de Gran Canaria
country: Spain
facility: Hs0005 40294
city: Madrid
country: Spain
facility: Hs0005 40268
city: Manises
country: Spain
facility: Hs0005 40297
city: Pontevedra
country: Spain
facility: Hs0005 40295
city: Sevilla
country: Spain
facility: Hs0005 40049
city: Valencia
country: Spain
facility: Hs0005 40230
city: Genève
country: Switzerland
facility: Hs0005 40406
city: Antalya
country: Turkey
facility: Hs0005 40270
city: Gaziantep
country: Turkey
facility: Hs0005 40273
city: Istanbul
country: Turkey
facility: Hs0005 40272
city: İ̇zmir
country: Turkey
facility: Hs0005 40271
city: Leeds
country: United Kingdom
facility: Hs0005 40339
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References: