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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04242446




Registration number
NCT04242446
Ethics application status
Date submitted
23/01/2020
Date registered
27/01/2020
Date last updated
7/05/2021

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
Scientific 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
Secondary ID [1] 0 0
2019-002550-23
Secondary ID [2] 0 0
HS0003
Universal Trial Number (UTN)
Trial acronym
BE HEARD I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bimekizumab
Other interventions - Placebo

Experimental: Bimekizumab dosing regimen 1 - Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the Treatment Period.

Experimental: Bimekizumab dosing regimen 2 - Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the Treatment Period.

Experimental: Bimekizumab dosing regimen 3 - Subjects participating in the study will receive assigned bimekizumab dosing regimen 3 during the Treatment Period.

Placebo Comparator: Placebo Group - Subjects randomized to this arm will receive placebo during the Initial Treatment Period and bimekizumab during the Maintenance Treatment Period.


Treatment: Drugs: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.

Other interventions: Placebo
Subjects will receive placebo at pre-specified time-points during the Initial Treatment Period.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16 - 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 fistula count.
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16 - 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 fistula count.
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of participants with Flare by Week 16 - Flare is defined as a =25% increase in AN count with an absolute increase in AN count of =2 relative to Baseline.
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Absolute change from Baseline in Skin Pain score at Week 16 - Skin Pain score is assessed by the "worst pain" item (11 point numeric rating scale) in the Hidradenitis Suppurativa Symptom Daily Diary (HSSDD).
Timepoint [3] 0 0
From Baseline (Day 1) to Week 16
Secondary outcome [4] 0 0
Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 - The DLQI is a skin disease specific questionnaire aimed at the evaluation of how symptoms and treatment affect participants' health related quality of life (QOL). The DLQI total score ranges from 0 to 30 with higher scores indicating lower skin health related QOL.
Timepoint [4] 0 0
From Baseline (Day 1) to Week 16
Secondary outcome [5] 0 0
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study - 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.
Timepoint [5] 0 0
From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Secondary outcome [6] 0 0
Percentage of participants with serious adverse events (SAEs) during the study - 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 events
Timepoint [6] 0 0
From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Secondary outcome [7] 0 0
Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study - 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.
Timepoint [7] 0 0
From Baseline (Day 1) until Safety Follow-Up (up to Week 71)

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

- Presence of active suicidal ideation, or moderately severe major depression or severe
major depression

- Subject has a history of chronic alcohol or drug abuse within 6 months prior to
Screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QuuensiandVIC
Recruitment hospital [1] 0 0
Hs0003 30012 - Woolloongabba
Recruitment hospital [2] 0 0
Hs0003 30011 - East Melbourne
Recruitment hospital [3] 0 0
Hs0003 30016 - Carlton
Recruitment hospital [4] 0 0
Hs0003 30015 - Hectorville
Recruitment hospital [5] 0 0
Hs0003 30017 - Kogarah
Recruitment postcode(s) [1] 0 0
- Woolloongabba
Recruitment postcode(s) [2] 0 0
- East Melbourne
Recruitment postcode(s) [3] 0 0
- Carlton
Recruitment postcode(s) [4] 0 0
- Hectorville
Recruitment postcode(s) [5] 0 0
- Kogarah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Nebraska
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
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Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Rhode Island
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
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Washington
Country [20] 0 0
Belgium
State/province [20] 0 0
Bruxelles
Country [21] 0 0
Belgium
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Leuven
Country [22] 0 0
Belgium
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Liège
Country [23] 0 0
Canada
State/province [23] 0 0
Barrie
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Canada
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Richmond Hill
Country [25] 0 0
Canada
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Saint John's
Country [26] 0 0
Canada
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Saskatoon
Country [27] 0 0
Canada
State/province [27] 0 0
Surrey
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Denmark
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Aarhus
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Denmark
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Copenhagen
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Denmark
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Roskilde
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France
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Amiens
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France
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Angers
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France
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Le Mans
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France
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Nice
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France
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Rouen
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France
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Saint-Mandé
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France
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Toulon
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Darmstadt
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Germany
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Dresden
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Germany
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Kiel
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Germany
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Magdeburg
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Germany
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Mainz
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Germany
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München
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Germany
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Münster
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Greece
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Athens
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Greece
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Thessaloníki
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Italy
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Catania
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Italy
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Roma
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Netherlands
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Groningen
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Netherlands
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Rotterdam
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Norway
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Trondheim
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Spain
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Badalona
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Spain
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Bilbao
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Spain
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Pontevedra
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Spain
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Sevilla
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Spain
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Valencia
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Switzerland
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Bern
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Turkey
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Ankara
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Antalya
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Turkey
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Gaziantep
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Turkey
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Istanbul
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Turkey
State/province [64] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
UCB Biopharma SRL
Address
Country

Ethics approval
Ethics application status

Summary
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)
Trial website
https://clinicaltrials.gov/show/NCT04242446
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
001 844 599 2273 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
UCB Cares
Address 0 0
Country 0 0
Phone 0 0
+1844599
Fax 0 0
Email 0 0
UCBCares@ucb.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04242446