Clinical trial NCT04242498: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hidradenitis Suppurativa
Keywords: Bimekizumab
UCB4940
HS
Hidradenitis Suppurativa
Acne inversa
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2020-01-27
Enrollment: 509
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)


Eligibility criteria: Inclusion Criteria:

* Participant must be at least 18 years of age, at the time of signing the informed consent. If a study participant is under the local age of consent and is at least 18 years of age, written informed consent will be obtained from both the study participant and the legal representative
* Study participants must have a diagnosis of Hidradenitis Suppurativa (HS) based on clinical history and physical examination for at least 6 months prior to the Baseline visit
* Study participant must have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla), 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline visits
* Study participant must have moderate to severe HS defined as a total of ≥5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline visits
* Study participant must have had an inadequate response to a course of a systemic antibiotic for treatment of HS as assessed by the Investigator through study participant interview and review of medical history
* 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 treatment period and for at least 20 weeks after the last dose of investigational medicinal product (IMP)

Exclusion Criteria:

* Draining tunnel count of \>20 at the Baseline Visit
* Any other active skin disease or condition (eg, bacterial cellulitis, candida intertrigo, extensive condyloma) that may, in the opinion of the Investigator, interfere with the assessment of hidradenitis suppurativa (HS)
* Study participant has a diagnosis of sarcoidosis, systemic lupus erythematosus, or active inflammatory bowel disease (IBD)
* Primary immunosuppressive condition, including taking immunosuppressive therapy following an organ transplant, or has had a splenectomy
* Female 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)
* Active infection or history of certain infection(s)
* Active tuberculosis (TB) infection, latent TB infection, high risk of exposure to TB infection, current or history of nontuberculous mycobacterium (NTM) infection
* Concurrent malignancy. Study participants with a history of malignancy within the past 5 years prior to the Screening Visit are excluded, EXCEPT if the malignancy was a cutaneous squamous or basal cell carcinoma, or in situ cervical cancer that has been treated and is considered cured
* History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease
* Known hypersensitivity to any components of bimekizumab or comparative drugs as stated in this protocol this protocol
* Concomitant and prior medication restrictions
* Myocardial infarction or stroke within the 6 months prior to the Screening Visit
* Study participant has the presence of active suicidal ideation, or positive suicide behavior using the "Screening" version of the electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
* Presence of moderately severe major depression or severe major depression
* Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening

Primary outcomes:
measure: Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16
timeFrame: Week 16
measure: Percentage of Participants With Flare by Week 16
timeFrame: From Baseline to Week 16
measure: Absolute Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
timeFrame: Baseline, Week 16
measure: Absolute Change From Baseline in Worst Skin Pain Score at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving Skin Pain Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
timeFrame: From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
measure: Percentage of Participants With Serious Treatment-emergent Adverse Events During the Study
timeFrame: From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From the Study
timeFrame: From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Hs0004 50162
state: California
city: Thousand Oaks
country: United States
facility: Hs0004 50196
state: California
city: Miami
country: United States
facility: Hs0004 50199
state: Florida
city: Orange Park
country: United States
facility: Hs0004 50152
state: Florida
city: Orlando
country: United States
facility: Hs0004 50144
state: Florida
city: Pembroke Pines
country: United States
facility: Hs0004 50184
state: Florida
city: Sandy Springs
country: United States
facility: Hs0004 50193
state: Georgia
city: Savannah
country: United States
facility: Hs0004 50223
state: Georgia
city: Skokie
country: United States
facility: Hs0004 50164
state: Illinois
city: Plainfield
country: United States
facility: Hs0004 50234
state: Indiana
city: Clarkston
country: United States
facility: Hs0004 50178
state: Michigan
city: Saint Louis
country: United States
facility: Hs0004 50105
state: Missouri
city: Henderson
country: United States
facility: Hs0004 50197
state: Nevada
city: Portsmouth
country: United States
facility: Hs0004 50159
state: New Hampshire
city: Verona
country: United States
facility: Hs0004 50200
state: New Jersey
city: Albuquerque
country: United States
facility: Hs0004 50237
state: New Mexico
city: Durham
country: United States
facility: Hs0004 50211
state: North Carolina
city: Winston-Salem
country: United States
facility: Hs0004 50179
state: North Carolina
city: Columbus
country: United States
facility: Hs0004 50145
state: Ohio
city: Fairborn
country: United States
facility: Hs0004 50202
state: Ohio
city: Philadelphia
country: United States
facility: Hs0004 50150
state: Pennsylvania
city: Greenville
country: United States
facility: Hs0004 50236
state: South Carolina
city: Johns Island
country: United States
facility: Hs0004 50084
state: South Carolina
city: Pflugerville
country: United States
facility: Hs0004 50148
state: Texas
city: Parkville
country: Australia
facility: Hs0004 30018
city: St Leonards
country: Australia
facility: Hs0004 30014
city: Westmead
country: Australia
facility: Hs0004 30009
city: Pleven
country: Bulgaria
facility: Hs0004 40313
city: Sofia
country: Bulgaria
facility: Hs0004 40284
city: Sofia
country: Bulgaria
facility: Hs0004 40311
city: Sofia
country: Bulgaria
facility: Hs0004 40314
city: Sofia
country: Bulgaria
facility: Hs0004 40315
city: Stara Zagora
country: Bulgaria
facility: Hs0004 40353
city: Cobourg
country: Canada
facility: Hs0004 50172
city: Edmonton
country: Canada
facility: Hs0004 50135
city: London
country: Canada
facility: Hs0004 50174
city: St. John's
country: Canada
facility: Hs0004 50189
city: Waterloo
country: Canada
facility: Hs0004 50134
city: Winnipeg
country: Canada
facility: Hs0004 50136
city: Praha 10
country: Czechia
facility: Hs0004 40194
city: Praha 5
country: Czechia
facility: Hs0004 40063
city: Antony
country: France
facility: Hs0004 40245
city: Auxerre
country: France
facility: Hs0004 40321
city: Bordeaux Cedex
country: France
facility: Hs0004 40129
city: La Rochelle
country: France
facility: Hs0004 40320
city: Lyon
country: France
facility: Hs0004 40247
city: Marseille
country: France
facility: Hs0004 40130
city: Reims
country: France
facility: Hs0004 40404
city: Saint-etienne
country: France
facility: Hs0004 40403
city: Toulouse
country: France
facility: Hs0004 40286
city: Berlin
country: Germany
facility: Hs0004 40289
city: Berlin
country: Germany
facility: Hs0004 40326
city: Dessau
country: Germany
facility: Hs0004 40322
city: Dresden
country: Germany
facility: Hs0004 40356
city: Frankfurt/main
country: Germany
facility: Hs0004 40287
city: Hamburg
country: Germany
facility: Hs0004 40142
city: Hannover
country: Germany
facility: Hs0004 40328
city: Lübeck
country: Germany
facility: Hs0004 40250
city: Debrecen
country: Hungary
facility: Hs0004 40254
city: Dublin
country: Ireland
facility: Hs0004 40344
city: Afula
country: Israel
facility: Hs0004 20090
city: Bunkyo-ku
country: Japan
facility: Hs0004 20196
city: Fukuoka
country: Japan
facility: Hs0004 20144
city: Itabashi-ku
country: Japan
facility: Hs0004 20043
city: Kagoshima
country: Japan
facility: Hs0004 20195
city: Kurume
country: Japan
facility: Hs0004 20170
city: Kyoto
country: Japan
facility: Hs0004 20190
city: Nagoya
country: Japan
facility: Hs0004 20033
city: Nakagami-gun
country: Japan
facility: Hs0004 20152
city: Nishinomiya
country: Japan
facility: Hs0004 20178
city: Obihiro
country: Japan
facility: Hs0004 20153
city: Osaka
country: Japan
facility: Hs0004 20037
city: Sapporo
country: Japan
facility: Hs0004 20154
city: Sendai
country: Japan
facility: Hs0004 20171
city: Lodz
country: Poland
facility: Hs0004 40347
city: Rzeszow
country: Poland
facility: Hs0004 40293
city: Warszawa
country: Poland
facility: Hs0004 40335
city: Wroclaw
country: Poland
facility: Hs0004 40095
city: Wroclaw
country: Poland
facility: Hs0004 40333
city: Wroclaw
country: Poland
facility: Hs0004 40334
city: Barcelona
country: Spain
facility: Hs0004 40159
city: Barcelona
country: Spain
facility: Hs0004 40267
city: Granada
country: Spain
facility: Hs0004 40298
city: Madrid
country: Spain
facility: Hs0004 40268
city: Manises
country: Spain
facility: Hs0004 40297
city: Sabadell
country: Spain
facility: Hs0004 40101
city: Cardiff
country: United Kingdom
facility: Hs0004 40300
city: Leeds
country: United Kingdom
facility: Hs0004 40339
city: London
country: United Kingdom
facility: Hs0004 40113
city: Newcastle Upon Tyne
country: United Kingdom
facility: Hs0004 40240
city: Northampton
country: United Kingdom
facility: Hs0004 40338
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References: