Clinical trial NCT04242446: 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: 505
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
* 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: 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 Worst 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: Birmingham
country: United States
facility: Hs0003 50140
state: Alabama
city: Phoenix
country: United States
facility: Hs0003 50175
state: Arizona
city: Los Angeles
country: United States
facility: Hs0003 50161
state: California
city: San Diego
country: United States
facility: Hs0003 50220
state: California
city: North Miami Beach
country: United States
facility: Hs0003 50205
state: Florida
city: Ormond Beach
country: United States
facility: Hs0003 50153
state: Florida
city: Tampa
country: United States
facility: Hs0003 50141
state: Florida
city: Atlanta
country: United States
facility: Hs0003 50210
state: Georgia
city: Watkinsville
country: United States
facility: Hs0003 50280
state: Georgia
city: Murray
country: United States
facility: Hs0003 50425
state: Kentucky
city: Beverly
country: United States
facility: Hs0003 50198
state: Massachusetts
city: Boston
country: United States
facility: Hs0003 50146
state: Massachusetts
city: Omaha
country: United States
facility: Hs0003 50194
state: Nebraska
city: Las Vegas
country: United States
facility: Hs0003 50208
state: Nevada
city: East Windsor
country: United States
facility: Hs0003 50137
state: New Jersey
city: New York
country: United States
facility: Hs0003 50235
state: New York
city: Chapel Hill
country: United States
facility: Hs0003 50151
state: North Carolina
city: Cincinnati
country: United States
facility: Hs0003 50177
state: Ohio
city: Columbus
country: United States
facility: Hs0003 50138
state: Ohio
city: Tulsa
country: United States
facility: Hs0003 50204
state: Oklahoma
city: Hershey
country: United States
facility: Hs0003 50147
state: Pennsylvania
city: Johnston
country: United States
facility: Hs0003 50008
state: Rhode Island
city: Providence
country: United States
facility: Hs0003 50180
state: Rhode Island
city: Nashville
country: United States
facility: Hs0003 50142
state: Tennessee
city: Arlington
country: United States
facility: Hs0003 50201
state: Texas
city: Dallas
country: United States
facility: Hs0003 50166
state: Texas
city: San Antonio
country: United States
facility: Hs0003 50149
state: Texas
city: Seattle
country: United States
facility: Hs0003 50270
state: Washington
city: Campbelltown
country: Australia
facility: Hs0003 30015
city: Carlton
country: Australia
facility: Hs0003 30016
city: East Melbourne
country: Australia
facility: Hs0003 30011
city: Kogarah
country: Australia
facility: Hs0003 30017
city: Woolloongabba
country: Australia
facility: Hs0003 30012
city: Brussels
country: Belgium
facility: Hs0003 40004
city: Bruxelles
country: Belgium
facility: Hs0003 40121
city: Leuven
country: Belgium
facility: Hs0003 40002
city: Liege
country: Belgium
facility: Hs0003 40060
city: Barrie
country: Canada
facility: Hs0003 50233
city: Richmond Hill
country: Canada
facility: Hs0003 50190
city: Saskatoon
country: Canada
facility: Hs0003 50192
city: St. John's
country: Canada
facility: Hs0003 50173
city: Surrey
country: Canada
facility: Hs0003 50133
city: Aarhus N
country: Denmark
facility: Hs0003 40127
city: Amiens Cedex 1
country: France
facility: Hs0003 40197
city: Angers
country: France
facility: Hs0003 40342
city: Le Mans
country: France
facility: Hs0003 40355
city: Nice
country: France
facility: Hs0003 40132
city: Rouen Cedex
country: France
facility: Hs0003 40318
city: Saint Mandé
country: France
facility: Hs0003 40246
city: Toulon
country: France
facility: Hs0003 40285
city: Berlin
country: Germany
facility: Hs0003 40325
city: Bochum
country: Germany
facility: Hs0003 40248
city: Bonn
country: Germany
facility: Hs0003 40327
city: Darmstadt
country: Germany
facility: Hs0003 40288
city: Dresden
country: Germany
facility: Hs0003 40324
city: Kiel
country: Germany
facility: Hs0003 40249
city: Magdeburg
country: Germany
facility: Hs0003 40357
city: Mainz
country: Germany
facility: Hs0003 40174
city: München
country: Germany
facility: Hs0003 40323
city: Münster
country: Germany
facility: Hs0003 40177
city: Athens
country: Greece
facility: Hs0003 40251
city: Athens
country: Greece
facility: Hs0003 40253
city: Thessaloniki
country: Greece
facility: Hs0003 40252
city: Haifa
country: Israel
facility: Hs0003 20089
city: Tel Aviv
country: Israel
facility: Hs0003 20088
city: Catania
country: Italy
facility: Hs0003 40261
city: Roma
country: Italy
facility: Hs0003 40257
city: Roma
country: Italy
facility: Hs0003 40263
city: Rozzano
country: Italy
facility: Hs0003 40258
city: Terracina
country: Italy
facility: Hs0003 40331
city: Torino
country: Italy
facility: Hs0003 40330
city: Breda
country: Netherlands
facility: Hs0003 40351
city: Groningen
country: Netherlands
facility: Hs0003 40292
city: Rotterdam
country: Netherlands
facility: Hs0003 40264
city: Trondheim
country: Norway
facility: Hs0003 40332
city: Badalona
country: Spain
facility: Hs0003 40266
city: Las Palmas de Gran Canaria
country: Spain
facility: Hs0003 40294
city: Pontevedra
country: Spain
facility: Hs0003 40295
city: Sevilla
country: Spain
facility: Hs0003 40049
city: Valencia
country: Spain
facility: Hs0003 40230
city: Bern
country: Switzerland
facility: Hs0003 40337
city: Genève
country: Switzerland
facility: Hs0003 40406
city: Ankara
country: Turkey
facility: Hs0003 40053
city: Antalya
country: Turkey
facility: Hs0003 40270
city: Gaziantep
country: Turkey
facility: Hs0003 40273
city: Istanbul
country: Turkey
facility: Hs0003 40050
city: Istanbul
country: Turkey
facility: Hs0003 40272
city: İ̇zmir
country: Turkey
facility: Hs0003 40271
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References: