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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04901195




Registration number
NCT04901195
Ethics application status
Date submitted
20/05/2021
Date registered
25/05/2021

Titles & IDs
Public title
A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
Scientific 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
Secondary ID [1] 0 0
2020-004179-42
Secondary ID [2] 0 0
HS0005
Universal Trial Number (UTN)
Trial acronym
BE HEARD EXT
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

Experimental: Bimekizumab dosing regimen 1 - Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the open-label extension period.

Experimental: Bimekizumab dosing regimen 2 - Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the open-label extension period.


Treatment: Drugs: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
Timepoint [1] 0 0
From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
Secondary outcome [1] 0 0
Percentage of participants with treatment-emergent serious adverse events (SAEs) during the study
Timepoint [1] 0 0
From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
Secondary outcome [2] 0 0
Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study
Timepoint [2] 0 0
From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
Secondary outcome [3] 0 0
Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
Percentage of participants with Flare
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) Response for Worst Pain
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score
Timepoint [7] 0 0
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

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/07/2026
Actual
Sample size
Target
Accrual to date
Final
658
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Hs0005 30015 - Campbelltown
Recruitment hospital [2] 0 0
Hs0005 30016 - Carlton
Recruitment hospital [3] 0 0
Hs0005 30011 - East Melbourne
Recruitment hospital [4] 0 0
Hs0005 30017 - Kogarah
Recruitment hospital [5] 0 0
Hs0005 30018 - Parkville
Recruitment hospital [6] 0 0
Hs0005 30014 - St Leonards
Recruitment hospital [7] 0 0
Hs0005 30009 - Westmead
Recruitment hospital [8] 0 0
Hs0005 30012 - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Campbelltown
Recruitment postcode(s) [2] 0 0
- Carlton
Recruitment postcode(s) [3] 0 0
- East Melbourne
Recruitment postcode(s) [4] 0 0
- Kogarah
Recruitment postcode(s) [5] 0 0
- Parkville
Recruitment postcode(s) [6] 0 0
- St Leonards
Recruitment postcode(s) [7] 0 0
- Westmead
Recruitment postcode(s) [8] 0 0
- Woolloongabba
Recruitment outside Australia
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Leeds

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 safety of long-term therapy of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)
Trial website
https://clinicaltrials.gov/study/NCT04901195
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: https://www.Vivli.org


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04901195