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

• ClinicalTrials.gov Identifier: NCT04901195
• Recruitment Status: Active, not recruiting
• First Posted: May 25, 2021
• Last Update Posted: April 15, 2024
• Sponsor: UCB Biopharma SRL
• Information provided by (Responsible Party): UCB Pharma ( UCB Biopharma SRL )

Tracking Information

• First Submitted Date: May 20, 2021
• First Posted Date: May 25, 2021
• Last Update Posted Date: April 15, 2024
• Actual Study Start Date: May 27, 2021
• Estimated Primary Completion Date: July 28, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 10, 2023)

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 196) ]

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.

Original Primary Outcome Measures (submitted: May 20, 2021)

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.

Current Secondary Outcome Measures (submitted: October 10, 2023)

• 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 196) ]
  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
• 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 196) ]
  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.
• 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, Week 116, Week 132, Week 148, Week 164, and Week 180 ]
  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.
• 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, Week 116, Week 132, Week 148, Week 164, and Week 180 ]
  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.
• Percentage of participants with Flare [ Time Frame: 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 ]
  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.
• 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, Week 116, Week 132, Week 148, Week 164, and Week 180 ]
  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.
• 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, Week 116, Week 132, Week 148, Week 164, and Week 180 ]
  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.

Original Secondary Outcome Measures (submitted: May 20, 2021)

• 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
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
• 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
• 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)
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hidradenitis Suppurativa

Intervention

Drug: Bimekizumab

Subjects will receive bimekizumab at pre-specified time-points.

Other Name: UCB4940

Study Arms

• Experimental: Bimekizumab dosing regimen 1
  Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the open-label extension period.
  Intervention: Drug: Bimekizumab
• Experimental: Bimekizumab dosing regimen 2
  Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the open-label extension period.
  Intervention: Drug: Bimekizumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: March 23, 2023): 658
• Original Estimated Enrollment (submitted: May 20, 2021): 830
• Estimated Study Completion Date: July 28, 2026
• Estimated Primary Completion Date: July 28, 2026 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Belgium, Bulgaria, Canada, Czechia, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Netherlands, Poland, Spain, Switzerland, Turkey, United Kingdom, United States
• Removed Location Countries: Israel

Administrative Information

• NCT Number: NCT04901195
• Other Study ID Numbers: HS0005; 2020-004179-42 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: 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

• Current Responsible Party: UCB Pharma ( UCB Biopharma SRL )
• Original Responsible Party: Same as current
• Current Study Sponsor: UCB Biopharma SRL
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: UCB Cares; 001 844 599 2273

• PRS Account: UCB Pharma
• Verification Date: April 2024