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BE HEARD I: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

Sponsor
UCB Biopharma SRL (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04242446
Collaborator
(none)
505
Enrollment
88
Locations
4
Arms
36.8
Anticipated Duration (Months)
5.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
505 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Feb 19, 2020
Actual Primary Completion Date :
Apr 7, 2022
Anticipated Study Completion Date :
Mar 16, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bimekizumab dosing regimen 1

Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the Treatment 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 Treatment Period.

    Drug: Bimekizumab
    Subjects will receive bimekizumab at pre-specified time-points.
    Other Names:
  • UCB4940

    		•
    Experimental: Bimekizumab dosing regimen 3

    Subjects participating in the study will receive assigned bimekizumab dosing regimen 3 during the Treatment Period.

    Drug: Bimekizumab
    Subjects will receive bimekizumab at pre-specified time-points.
    Other Names:
  • UCB4940

    		•
    Placebo Comparator: Placebo Group

    Subjects randomized to this arm will receive placebo during the Initial Treatment Period and bimekizumab during the Maintenance Treatment Period.

    Drug: Bimekizumab
    Subjects will receive bimekizumab at pre-specified time-points.
    Other Names:
  • UCB4940

    • Other: Placebo
    Subjects will receive placebo at pre-specified time-points during the Initial Treatment Period.
    Other Names:
  • PBO

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16 [Week 16]

      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.

    Secondary Outcome Measures

    1. Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16 [Week 16]

      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.

    2. Percentage of participants with Flare by Week 16 [Week 16]

      Flare is defined as a ≥25% increase in AN count with an absolute increase in AN count of ≥2 relative to Baseline.

    3. Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 [From Baseline (Day 1) to Week 16]

      The DLQI is a skin disease specific questionnaire aimed at the evaluation of how symptoms and treatment affect participants' health related quality of life (QOL). The DLQI total score ranges from 0 to 30 with higher scores indicating lower skin health related QOL.

    4. Absolute change from Baseline in Skin Pain score at Week 16 [From Baseline (Day 1) to Week 16]

      Skin Pain score is assessed by the "worst pain" item (11 point numeric rating scale) in the Hidradenitis Suppurativa Symptom Daily Diary (HSSDD).

    5. Percentage of participants achieving Skin Pain response at Week 16 [From Baseline (Day 1) to Week 16]

      Pain response is defined as a decrease from Baseline in Hidradenitis Suppurativa Symptom Daily Diary (HSSDD) weekly worst skin pain score at or beyond the threshold for within-patient clinically meaningful change.

    6. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study [From Baseline (Day 1) until Safety Follow-Up (up to Week 71)]

      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.

    7. Percentage of participants with serious treatment-emergent adverse events during the study [From Baseline (Day 1) until Safety Follow-Up (up to Week 71)]

      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

    8. Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study [From Baseline (Day 1) until Safety Follow-Up (up to Week 71)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    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

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hs0003 50140 Birmingham Alabama United States 35233
    2 Hs0003 50175 Phoenix Arizona United States 85006
    3 Hs0003 50161 Los Angeles California United States 90045
    4 Hs0003 50220 San Diego California United States 92123
    5 Hs0003 50205 North Miami Beach Florida United States 33162-4708
    6 Hs0003 50153 Ormond Beach Florida United States 32174
    7 Hs0003 50141 Tampa Florida United States 33613
    8 Hs0003 50210 Atlanta Georgia United States 30309
    9 Hs0003 50280 Watkinsville Georgia United States 30677
    10 Hs0003 50425 Murray Kentucky United States 42071
    11 Hs0003 50198 Beverly Massachusetts United States 01915
    12 Hs0003 50146 Boston Massachusetts United States 02215
    13 Hs0003 50194 Omaha Nebraska United States 68144
    14 Hs0003 50208 Las Vegas Nevada United States 89148
    15 Hs0003 50137 East Windsor New Jersey United States 08520
    16 Hs0003 50235 New York New York United States 10003
    17 Hs0003 50151 Chapel Hill North Carolina United States 27516
    18 Hs0003 50177 Cincinnati Ohio United States 45219
    19 Hs0003 50138 Columbus Ohio United States 43213
    20 Hs0003 50204 Tulsa Oklahoma United States 74135
    21 Hs0003 50147 Hershey Pennsylvania United States 17033
    22 Hs0003 50008 Johnston Rhode Island United States 02919
    23 Hs0003 50180 Providence Rhode Island United States 02903
    24 Hs0003 50142 Nashville Tennessee United States 37215
    25 Hs0003 50201 Arlington Texas United States 76011
    26 Hs0003 50166 Dallas Texas United States 75246
    27 Hs0003 50149 San Antonio Texas United States 78213
    28 Hs0003 50270 Seattle Washington United States 98101
    29 Hs0003 30015 Campbelltown Australia
    30 Hs0003 30016 Carlton Australia
    31 Hs0003 30011 East Melbourne Australia
    32 Hs0003 30017 Kogarah Australia
    33 Hs0003 30012 Woolloongabba Australia
    34 Hs0003 40004 Brussels Belgium
    35 Hs0003 40121 Bruxelles Belgium
    36 Hs0003 40002 Leuven Belgium
    37 Hs0003 40060 Liege Belgium
    38 Hs0003 50233 Barrie Canada
    39 Hs0003 50190 Richmond Hill Canada
    40 Hs0003 50192 Saskatoon Canada
    41 Hs0003 50173 St. John's Canada
    42 Hs0003 50133 Surrey Canada
    43 Hs0003 40127 Aarhus N Denmark
    44 Hs0003 40197 Amiens Cedex France
    45 Hs0003 40342 Angers France
    46 Hs0003 40355 Le Mans France
    47 Hs0003 40132 Nice France
    48 Hs0003 40318 Rouen Cedex France
    49 Hs0003 40246 Saint Mandé France
    50 Hs0003 40285 Toulon France
    51 Hs0003 40325 Berlin Germany
    52 Hs0003 40248 Bochum Germany
    53 Hs0003 40327 Bonn Germany
    54 Hs0003 40288 Darmstadt Germany
    55 Hs0003 40324 Dresden Germany
    56 Hs0003 40249 Kiel Germany
    57 Hs0003 40357 Magdeburg Germany
    58 Hs0003 40174 Mainz Germany
    59 Hs0003 40323 München Germany
    60 Hs0003 40177 Münster Germany
    61 Hs0003 40251 Athens Greece
    62 Hs0003 40253 Athens Greece
    63 Hs0003 40252 Thessaloniki Greece
    64 Hs0003 20089 Haifa Israel
    65 Hs0003 20088 Tel Aviv Israel
    66 Hs0003 40261 Catania Italy
    67 Hs0003 40257 Roma Italy
    68 Hs0003 40263 Roma Italy
    69 Hs0003 40258 Rozzano Italy
    70 Hs0003 40331 Terracina Italy
    71 Hs0003 40330 Torino Italy
    72 Hs0003 40351 Breda Netherlands
    73 Hs0003 40292 Groningen Netherlands
    74 Hs0003 40264 Rotterdam Netherlands
    75 Hs0003 40332 Trondheim Norway
    76 Hs0003 40266 Badalona Spain
    77 Hs0003 40294 Las Palmas de Gran Canaria Spain
    78 Hs0003 40295 Pontevedra Spain
    79 Hs0003 40049 Sevilla Spain
    80 Hs0003 40230 Valencia Spain
    81 Hs0003 40337 Bern Switzerland
    82 Hs0003 40406 Genève Switzerland
    83 Hs0003 40053 Ankara Turkey
    84 Hs0003 40270 Antalya Turkey
    85 Hs0003 40273 Gaziantep Turkey
    86 Hs0003 40050 Istanbul Turkey
    87 Hs0003 40272 Istanbul Turkey
    88 Hs0003 40271 İ̇zmir Turkey

    Sponsors and Collaborators

    • UCB Biopharma SRL

    Investigators

    • Study Director: UCB Cares, 001 844 599 2273 (UCB)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    UCB Biopharma SRL
    ClinicalTrials.gov Identifier:
    NCT04242446
    Other Study ID Numbers:
    • HS0003
    • 2019-002550-23
    First Posted:
    Jan 27, 2020
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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 Biopharma SRL
    Bimekizumab
    UCB4940
    HS
    Hidradenitis Suppurativa
    Acne inversa
    Additional relevant MeSH terms:
    Hidradenitis Suppurativa
    Hidradenitis

    Study Results

    No Results Posted as of Aug 24, 2022