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A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD EXT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04901195
Recruitment Status : Enrolling by invitation
First Posted : May 25, 2021
Last Update Posted : June 21, 2022
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

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)

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Drug: Bimekizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 830 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : May 27, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bimekizumab dosing regimen 1
Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the open-label extension period.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other Name: UCB4940

Experimental: Bimekizumab dosing regimen 2
Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the open-label extension period.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other Name: UCB4940




Primary Outcome Measures :
  1. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study [ Time Frame: From Baseline (Day 1) until end of Safety Follow-Up (up to Week 120) ]
    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.


Secondary Outcome Measures :
  1. Percentage of participants with treatment-emergent serious adverse events (SAEs) during the study [ Time Frame: From Baseline (Day 1) until end of Safety Follow-Up (up to Week 120) ]

    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

  2. Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study [ Time Frame: From Baseline (Day 1) until end of Safety Follow-Up (up to Week 120) ]
    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.

  3. Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) [ Time Frame: Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100 ]

    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 tunnel count.

    Results will be presented individually per week listed under time points.


  4. Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) [ Time Frame: Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100 ]

    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 tunnel count.

    Results will be presented individually per week listed under time points.


  5. Percentage of participants with Flare [ Time Frame: Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100 ]

    Flare is defined as a ≥25 % increase in abscess and inflammatory nodule (AN) count with an absolute increase in AN count of ≥2 relative to Baseline.

    Results will be presented individually per week listed under time points.


  6. Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) Response for Worst Pain [ Time Frame: Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100 ]

    The 4 items on the HSSQ assess the study participant's perception of the core symptoms of HS experienced in the past 7 days - pain, smell or odor, drainage or oozing from HS lesions, and itch on an 11-point numeric rating scale with higher scores indicating higher symptom level.

    Results will be presented individually per week listed under time points.


  7. Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score [ Time Frame: Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100 ]

    The DLQI is a skin disease specific questionnaire aimed at the evaluation of how the disease affects participants health related quality of life (QOL). The DLQI total score ranges from 0 to 30 with higher scores indicating higher skin disease impact on QOL.

    Results will be presented individually per week listed under time points.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04901195


Locations
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Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT04901195    
Other Study ID Numbers: HS0005
2020-004179-42 ( EudraCT Number )
First Posted: May 25, 2021    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 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.
Access Criteria: 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.
URL: https://www.Vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
Bimekizumab
UCB4940
HS
Hidradenitis Suppurativa
Acne inversa
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Suppuration