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

April 11, 2024 updated by: UCB Biopharma SRL

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

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)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

658

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Campbelltown, Australia
        • Hs0005 30015
      • Carlton, Australia
        • Hs0005 30016
      • East Melbourne, Australia
        • Hs0005 30011
      • Kogarah, Australia
        • Hs0005 30017
      • Parkville, Australia
        • Hs0005 30018
      • St Leonards, Australia
        • Hs0005 30014
      • Westmead, Australia
        • Hs0005 30009
      • Woolloongabba, Australia
        • Hs0005 30012
  • Belgium
      • Leuven, Belgium
        • Hs0005 40002
      • Woluwe-saint-lambert, Belgium
        • Hs0005 40121
  • Bulgaria
      • Pleven, Bulgaria
        • Hs0005 40313
      • Sofia, Bulgaria
        • Hs0005 40284
      • Sofia, Bulgaria
        • Hs0005 40311
      • Sofia, Bulgaria
        • Hs0005 40314
      • Sofia, Bulgaria
        • Hs0005 40315
      • Stara Zagora, Bulgaria
        • Hs0005 40353
  • Canada
      • Barrie, Canada
        • Hs0005 50233
      • Cobourg, Canada
        • Hs0005 50172
      • Edmonton, Canada
        • Hs0005 50135
      • London, Canada
        • Hs0005 50174
      • Richmond Hill, Canada
        • Hs0005 50190
      • Saskatoon, Canada
        • Hs0005 50192
      • Surrey, Canada
        • Hs0005 50133
      • Waterloo, Canada
        • Hs0005 50134
      • Winnipeg, Canada
        • Hs0005 50136
  • Czechia
      • Praha 10, Czechia
        • Hs0005 40194
      • Praha 5, Czechia
        • Hs0005 40063
  • France
      • Amiens Cedex, France
        • Hs0005 40197
      • Antony, France
        • Hs0005 40245
      • Auxerre, France
        • Hs0005 40321
      • La Rochelle, France
        • Hs0005 40320
      • Le Mans, France
        • Hs0005 40355
      • Lyon, France
        • Hs0005 40247
      • Marseille, France
        • Hs0005 40130
      • Nice, France
        • Hs0005 40132
      • Reims, France
        • Hs0005 40404
      • Rouen Cedex, France
        • Hs0005 40318
      • Saint Mandé, France
        • Hs0005 40246
      • Saint-etienne, France
        • Hs0005 40403
      • Toulon, France
        • Hs0005 40285
      • Toulouse, France
        • Hs0005 40286
  • Germany
      • Berlin, Germany
        • Hs0005 40325
      • Berlin, Germany
        • Hs0005 40326
      • Bochum, Germany
        • Hs0005 40248
      • Bonn, Germany
        • Hs0005 40327
      • Darmstadt, Germany
        • Hs0005 40288
      • Dresden, Germany
        • Hs0005 40324
      • Dresden, Germany
        • Hs0005 40356
      • Frankfurt/main, Germany
        • Hs0005 40287
      • Hamburg, Germany
        • Hs0005 40142
      • Hannover, Germany
        • Hs0005 40328
      • Kiel, Germany
        • Hs0005 40249
      • Lübeck, Germany
        • Hs0005 40250
      • Mainz, Germany
        • Hs0005 40174
      • München, Germany
        • Hs0005 40323
      • Münster, Germany
        • Hs0005 40177
  • Greece
      • Athens, Greece
        • Hs0005 40251
      • Thessaloniki, Greece
        • Hs0005 40252
  • Hungary
      • Debrecen, Hungary
        • Hs0005 40254
  • Ireland
      • Dublin, Ireland
        • Hs0005 40344
  • Italy
      • Catania, Italy
        • Hs0005 40261
      • Roma, Italy
        • Hs0005 40263
      • Rozzano, Italy
        • Hs0005 40258
      • Turin, Italy
        • Hs0005 40330
  • Japan
      • Bunkyo-ku, Japan
        • Hs0005 20196
      • Fukuoka, Japan
        • Hs0005 20144
      • Itabashi-ku, Japan
        • Hs0005 20043
      • Kagoshima, Japan
        • Hs0005 20195
      • Kurume, Japan
        • Hs0005 20170
      • Kyoto, Japan
        • Hs0005 20190
      • Nagoya, Japan
        • Hs0005 20033
      • Nakagami-gun, Japan
        • Hs0005 20152
      • Nishinomiya, Japan
        • Hs0005 20178
      • Obihiro, Japan
        • Hs0005 20153
      • Osaka, Japan
        • Hs0005 20037
      • Sapporo, Japan
        • Hs0005 20154
      • Sendai, Japan
        • Hs0005 20171
  • Netherlands
      • Breda, Netherlands
        • Hs0005 40351
      • Groningen, Netherlands
        • Hs0005 40292
      • Rotterdam, Netherlands
        • Hs0005 40264
  • Poland
      • Lodz, Poland
        • Hs0005 40347
      • Rzeszow, Poland
        • Hs0005 40293
      • Warszawa, Poland
        • Hs0005 40335
      • Wroclaw, Poland
        • Hs0005 40095
      • Wroclaw, Poland
        • Hs0005 40333
      • Wroclaw, Poland
        • Hs0005 40334
  • Spain
      • Badalona, Spain
        • Hs0005 40266
      • Barcelona, Spain
        • Hs0005 40159
      • Barcelona, Spain
        • Hs0005 40267
      • Granada, Spain
        • Hs0005 40298
      • Las Palmas de Gran Canaria, Spain
        • Hs0005 40294
      • Madrid, Spain
        • Hs0005 40268
      • Manises, Spain
        • Hs0005 40297
      • Pontevedra, Spain
        • Hs0005 40295
      • Sevilla, Spain
        • Hs0005 40049
      • Valencia, Spain
        • Hs0005 40230
  • Switzerland
      • Genève, Switzerland
        • Hs0005 40406
  • Turkey
      • Antalya, Turkey
        • Hs0005 40270
      • Gaziantep, Turkey
        • Hs0005 40273
      • Istanbul, Turkey
        • Hs0005 40272
      • İ̇zmir, Turkey
        • Hs0005 40271
  • United Kingdom
      • Leeds, United Kingdom
        • Hs0005 40339
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Hs0005 50140
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Hs0005 50175
    • California
      • Fountain Valley, California, United States, 92708
        • Hs0005 50162
      • Los Angeles, California, United States, 90045
        • Hs0005 50161
      • San Diego, California, United States, 92123
        • Hs0005 50220
      • Thousand Oaks, California, United States, 91320
        • Hs0005 50196
    • Florida
      • Miami, Florida, United States, 33125
        • Hs0005 50199
      • North Miami Beach, Florida, United States, 33162-4708
        • Hs0005 50205
      • Orange Park, Florida, United States, 32073
        • Hs0005 50152
      • Pembroke Pines, Florida, United States, 33028
        • Hs0005 50184
      • Tampa, Florida, United States, 33606
        • Hs0005 50141
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Hs0005 50193
      • Watkinsville, Georgia, United States, 30677
        • Hs0005 50280
    • Indiana
      • Plainfield, Indiana, United States, 46168
        • Hs0005 50234
    • Kentucky
      • Murray, Kentucky, United States, 42071
        • Hs0005 50425
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • Hs0005 50198
      • Boston, Massachusetts, United States, 02215
        • Hs0005 50146
    • Michigan
      • Clarkston, Michigan, United States, 48346
        • Hs0005 50178
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Hs0005 50105
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Hs0005 50194
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Hs0005 50208
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Hs0005 50159
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Hs0005 50137
      • Verona, New Jersey, United States, 07044
        • Hs0005 50200
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Hs0005 50237
    • New York
      • New York, New York, United States, 10003
        • Hs0005 50235
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • Hs0005 50151
      • Durham, North Carolina, United States, 27710
        • Hs0005 50211
      • Winston-Salem, North Carolina, United States, 27157
        • Hs0005 50179
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Hs0005 50177
      • Columbus, Ohio, United States, 43213
        • Hs0005 50138
      • Columbus, Ohio, United States, 43230
        • Hs0005 50145
      • Fairborn, Ohio, United States, 45324
        • Hs0005 50202
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74137
        • Hs0005 50204
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Hs0005 50147
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Hs0005 50008
      • Providence, Rhode Island, United States, 02903
        • Hs0005 50180
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Hs0005 50084
      • Greenville, South Carolina, United States, 29615
        • Hs0005 50236
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Hs0005 50142
    • Texas
      • Arlington, Texas, United States, 76011
        • Hs0005 50201
      • Pflugerville, Texas, United States, 78660
        • Hs0005 50148
    • Washington
      • Seattle, Washington, United States, 98101
        • Hs0005 50270

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • UCB4940

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
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.
From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
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.
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
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.
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
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.
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
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.
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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Biopharma SRL

Investigators

  • Study Director: UCB Cares, 001 844 599 2273

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2021

Primary Completion (Estimated)

July 28, 2026

Study Completion (Estimated)

July 28, 2026

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

May 20, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS0005
  • 2020-004179-42 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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