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

NCT ID: NCT04242498

Last Updated: 2025-11-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

509 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-02

Study Completion Date

2022-09-28

Brief Summary

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

Detailed Description

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Conditions

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Hidradenitis Suppurativa

Keywords

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Bimekizumab UCB4940 HS Hidradenitis Suppurativa Acne inversa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bimekizumab dosing regimen 1

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

Group Type EXPERIMENTAL

Bimekizumab

Intervention Type DRUG

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

Bimekizumab dosing regimen 2

Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the Treatment Period.

Group Type EXPERIMENTAL

Bimekizumab

Intervention Type DRUG

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

Bimekizumab dosing regimen 3

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

Group Type EXPERIMENTAL

Bimekizumab

Intervention Type DRUG

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

Placebo Group

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

Group Type PLACEBO_COMPARATOR

Bimekizumab

Intervention Type DRUG

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

Placebo

Intervention Type OTHER

Subjects will receive placebo at pre-specified time-points during the Initial Treatment Period.

Interventions

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Bimekizumab

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

Intervention Type DRUG

Placebo

Subjects will receive placebo at pre-specified time-points during the Initial Treatment Period.

Intervention Type OTHER

Other Intervention Names

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UCB4940 PBO

Eligibility Criteria

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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 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Biopharma SRL

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273

Locations

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Hs0004 50162

Fountain Valley, California, United States

Site Status

Hs0004 50196

Thousand Oaks, California, United States

Site Status

Hs0004 50199

Miami, Florida, United States

Site Status

Hs0004 50152

Orange Park, Florida, United States

Site Status

Hs0004 50144

Orlando, Florida, United States

Site Status

Hs0004 50184

Pembroke Pines, Florida, United States

Site Status

Hs0004 50193

Sandy Springs, Georgia, United States

Site Status

Hs0004 50223

Savannah, Georgia, United States

Site Status

Hs0004 50164

Skokie, Illinois, United States

Site Status

Hs0004 50234

Plainfield, Indiana, United States

Site Status

Hs0004 50178

Clarkston, Michigan, United States

Site Status

Hs0004 50105

St Louis, Missouri, United States

Site Status

Hs0004 50197

Henderson, Nevada, United States

Site Status

Hs0004 50159

Portsmouth, New Hampshire, United States

Site Status

Hs0004 50200

Verona, New Jersey, United States

Site Status

Hs0004 50237

Albuquerque, New Mexico, United States

Site Status

Hs0004 50211

Durham, North Carolina, United States

Site Status

Hs0004 50179

Winston-Salem, North Carolina, United States

Site Status

Hs0004 50145

Columbus, Ohio, United States

Site Status

Hs0004 50202

Fairborn, Ohio, United States

Site Status

Hs0004 50150

Philadelphia, Pennsylvania, United States

Site Status

Hs0004 50236

Greenville, South Carolina, United States

Site Status

Hs0004 50084

Johns Island, South Carolina, United States

Site Status

Hs0004 50148

Pflugerville, Texas, United States

Site Status

Hs0004 30018

Parkville, , Australia

Site Status

Hs0004 30014

St Leonards, , Australia

Site Status

Hs0004 30009

Westmead, , Australia

Site Status

Hs0004 40313

Pleven, , Bulgaria

Site Status

Hs0004 40284

Sofia, , Bulgaria

Site Status

Hs0004 40311

Sofia, , Bulgaria

Site Status

Hs0004 40314

Sofia, , Bulgaria

Site Status

Hs0004 40315

Sofia, , Bulgaria

Site Status

Hs0004 40353

Stara Zagora, , Bulgaria

Site Status

Hs0004 50172

Cobourg, , Canada

Site Status

Hs0004 50135

Edmonton, , Canada

Site Status

Hs0004 50174

London, , Canada

Site Status

Hs0004 50189

St. John's, , Canada

Site Status

Hs0004 50134

Waterloo, , Canada

Site Status

Hs0004 50136

Winnipeg, , Canada

Site Status

Hs0004 40063

Prague, , Czechia

Site Status

Hs0004 40194

Prague, , Czechia

Site Status

Hs0004 40245

Antony, , France

Site Status

Hs0004 40321

Auxerre, , France

Site Status

Hs0004 40129

Bordeaux, , France

Site Status

Hs0004 40320

La Rochelle, , France

Site Status

Hs0004 40247

Lyon, , France

Site Status

Hs0004 40130

Marseille, , France

Site Status

Hs0004 40404

Reims, , France

Site Status

Hs0004 40403

Saint-Etienne, , France

Site Status

Hs0004 40286

Toulouse, , France

Site Status

Hs0004 40289

Berlin, , Germany

Site Status

Hs0004 40326

Berlin, , Germany

Site Status

Hs0004 40322

Dessau, , Germany

Site Status

Hs0004 40356

Dresden, , Germany

Site Status

Hs0004 40287

Frankfurt am Main, , Germany

Site Status

Hs0004 40142

Hamburg, , Germany

Site Status

Hs0004 40328

Hanover, , Germany

Site Status

Hs0004 40250

Lübeck, , Germany

Site Status

Hs0004 40254

Debrecen, , Hungary

Site Status

Hs0004 40344

Dublin, , Ireland

Site Status

Hs0004 20090

Afula, , Israel

Site Status

Hs0004 20196

Bunkyō City, , Japan

Site Status

Hs0004 20144

Fukuoka, , Japan

Site Status

Hs0004 20043

Itabashi-ku, , Japan

Site Status

Hs0004 20195

Kagoshima, , Japan

Site Status

Hs0004 20170

Kurume, , Japan

Site Status

Hs0004 20190

Kyoto, , Japan

Site Status

Hs0004 20033

Nagoya, , Japan

Site Status

Hs0004 20152

Nakagami-gun, , Japan

Site Status

Hs0004 20178

Nishinomiya, , Japan

Site Status

Hs0004 20153

Obihiro, , Japan

Site Status

Hs0004 20037

Osaka, , Japan

Site Status

Hs0004 20154

Sapporo, , Japan

Site Status

Hs0004 20171

Sendai, , Japan

Site Status

Hs0004 40347

Lodz, , Poland

Site Status

Hs0004 40293

Rzeszów, , Poland

Site Status

Hs0004 40335

Warsaw, , Poland

Site Status

Hs0004 40095

Wroclaw, , Poland

Site Status

Hs0004 40333

Wroclaw, , Poland

Site Status

Hs0004 40334

Wroclaw, , Poland

Site Status

Hs0004 40159

Barcelona, , Spain

Site Status

Hs0004 40267

Barcelona, , Spain

Site Status

Hs0004 40298

Granada, , Spain

Site Status

Hs0004 40268

Madrid, , Spain

Site Status

Hs0004 40297

Manises, , Spain

Site Status

Hs0004 40101

Sabadell, , Spain

Site Status

Hs0004 40300

Cardiff, , United Kingdom

Site Status

Hs0004 40339

Leeds, , United Kingdom

Site Status

Hs0004 40113

London, , United Kingdom

Site Status

Hs0004 40240

Newcastle upon Tyne, , United Kingdom

Site Status

Hs0004 40338

Northampton, , United Kingdom

Site Status

Countries

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United States Australia Bulgaria Canada Czechia France Germany Hungary Ireland Israel Japan Poland Spain United Kingdom

References

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Kirby JS, Thorlacius L, Lambert J, Ciaravino V, Rolleri R, Pansar I, Muller E, Pelligra CG, Ingram JR. Psychometric validation and interpretation thresholds of the Hidradenitis Suppurativa Quality of Life (HiSQOL(c)) questionnaire using pooled data from the phase III BE HEARD I & II trials of bimekizumab in hidradenitis suppurativa. Br J Dermatol. 2025 Jun 20;193(1):93-104. doi: 10.1093/bjd/ljaf067.

Reference Type RESULT
PMID: 40172122 (View on PubMed)

Ingram JR, Lambert J, Ciaravino V, Rolleri R, Pansar I, Peterson L, Pelligra CG, Thorlacius L. Hidradenitis Suppurativa Symptom Daily Diary (HSSDD) and Questionnaire (HSSQ): Psychometric Validation and Interpretation Threshold Derivation Using Phase 3 Study Data. Dermatol Ther (Heidelb). 2025 May;15(5):1093-1111. doi: 10.1007/s13555-025-01346-w. Epub 2025 Mar 28.

Reference Type RESULT
PMID: 40153232 (View on PubMed)

Shi VY, Ingram JR, Lev-Tov H, Schneider-Burrus S, Forman S, Porter ML, Hayama K, Thorlacius L, Lambert J, Vaux T, Lukowski B, Rolleri RL, Szepietowski JC. Bimekizumab Impact on Patient-Reported Outcomes in Patients with Moderate to Severe Hidradenitis Suppurativa: Pooled 48-Week Results from BE HEARD I&II. Dermatol Ther (Heidelb). 2025 Sep;15(9):2553-2570. doi: 10.1007/s13555-025-01465-4. Epub 2025 Jul 13.

Reference Type RESULT
PMID: 40652434 (View on PubMed)

Ingram JR, Fujita H, Gottlieb AB, Lev-Tov H, Prens E, Sayed CJ, Shi VY, Szepietowski JC, Takahashi K, Frew JW, Lambert J, Davis L, Oh T, Rolleri R, Saintmard MH, Orenstein LAV. Bimekizumab Pain Outcomes in Patients with Hidradenitis Suppurativa: Pooled 48-Week Results from BE HEARD I&II Phase 3 Randomized Clinical Trials. Pain Ther. 2025 Oct 17. doi: 10.1007/s40122-025-00779-7. Online ahead of print.

Reference Type RESULT
PMID: 41107641 (View on PubMed)

Kimball AB, Jemec GBE, Sayed CJ, Kirby JS, Prens E, Ingram JR, Garg A, Gottlieb AB, Szepietowski JC, Bechara FG, Giamarellos-Bourboulis EJ, Fujita H, Rolleri R, Joshi P, Dokhe P, Muller E, Peterson L, Madden C, Bari M, Zouboulis CC. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48-week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials. Lancet. 2024 Jun 8;403(10443):2504-2519. doi: 10.1016/S0140-6736(24)00101-6. Epub 2024 May 22.

Reference Type DERIVED
PMID: 38795716 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2019-002551-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HS0004

Identifier Type: -

Identifier Source: org_study_id