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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04242498




Registration number
NCT04242498
Ethics application status
Date submitted
23/01/2020
Date registered
27/01/2020

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
2019-002551-42
Secondary ID [2] 0 0
HS0004
Universal Trial Number (UTN)
Trial acronym
BE HEARD II
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
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
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of Participants With Flare by Week 16
Timepoint [2] 0 0
From Baseline to Week 16
Secondary outcome [3] 0 0
Absolute Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
Timepoint [3] 0 0
Baseline, Week 16
Secondary outcome [4] 0 0
Absolute Change From Baseline in Worst Skin Pain Score at Week 16
Timepoint [4] 0 0
Baseline, Week 16
Secondary outcome [5] 0 0
Percentage of Participants Achieving Skin Pain Response at Week 16
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
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 Serious Treatment-emergent Adverse Events During the Study
Timepoint [7] 0 0
From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Secondary outcome [8] 0 0
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From the Study
Timepoint [8] 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
Sex
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 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

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/09/2022
Sample size
Target
Accrual to date
Final
509
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Hs0004 30018 - Parkville
Recruitment hospital [2] 0 0
Hs0004 30014 - St Leonards
Recruitment hospital [3] 0 0
Hs0004 30009 - Westmead
Recruitment postcode(s) [1] 0 0
- Parkville
Recruitment postcode(s) [2] 0 0
- St Leonards
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment outside Australia
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United States of America
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California
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Florida
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Georgia
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Illinois
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Indiana
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Michigan
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Missouri
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Nevada
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New Hampshire
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New Jersey
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New Mexico
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Texas
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Bulgaria
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Pleven
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Canada
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Cobourg
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Canada
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Edmonton
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Canada
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London
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Canada
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St. John's
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Canada
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Waterloo
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Canada
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Winnipeg
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Czechia
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Praha 10
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Czechia
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Praha 5
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France
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Antony
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France
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Auxerre
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France
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Bordeaux Cedex
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La Rochelle
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Lyon
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Reims
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France
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Saint-etienne
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Toulouse
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Germany
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Berlin
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Germany
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Dessau
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Germany
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Dresden
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Germany
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Frankfurt/main
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Hamburg
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Germany
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Hannover
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Germany
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Lübeck
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Hungary
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Debrecen
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Ireland
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Dublin
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Israel
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Afula
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Japan
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Bunkyo-ku
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Fukuoka
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Itabashi-ku
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Kagoshima
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Kurume
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Kyoto
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Nagoya
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Nakagami-gun
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Nishinomiya
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Obihiro
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Osaka
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Sapporo
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Japan
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Sendai
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Poland
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Lodz
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Poland
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Rzeszow
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Poland
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Warszawa
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Poland
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Wroclaw
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Spain
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Barcelona
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Spain
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Granada
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Spain
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Madrid
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Spain
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Manises
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Spain
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Sabadell
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Cardiff
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Leeds
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United Kingdom
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London
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Northampton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
001 844 599 2273
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Available to whom?
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.Vivli.org


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04242498