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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: NCT04242446

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

505 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-19

Study Completion Date

2023-02-19

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
* 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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Hs0003 50140

Birmingham, Alabama, United States

Site Status

Hs0003 50175

Phoenix, Arizona, United States

Site Status

Hs0003 50161

Los Angeles, California, United States

Site Status

Hs0003 50220

San Diego, California, United States

Site Status

Hs0003 50205

North Miami Beach, Florida, United States

Site Status

Hs0003 50153

Ormond Beach, Florida, United States

Site Status

Hs0003 50141

Tampa, Florida, United States

Site Status

Hs0003 50210

Atlanta, Georgia, United States

Site Status

Hs0003 50280

Watkinsville, Georgia, United States

Site Status

Hs0003 50425

Murray, Kentucky, United States

Site Status

Hs0003 50198

Beverly, Massachusetts, United States

Site Status

Hs0003 50146

Boston, Massachusetts, United States

Site Status

Hs0003 50194

Omaha, Nebraska, United States

Site Status

Hs0003 50208

Las Vegas, Nevada, United States

Site Status

Hs0003 50137

East Windsor, New Jersey, United States

Site Status

Hs0003 50235

New York, New York, United States

Site Status

Hs0003 50151

Chapel Hill, North Carolina, United States

Site Status

Hs0003 50177

Cincinnati, Ohio, United States

Site Status

Hs0003 50138

Columbus, Ohio, United States

Site Status

Hs0003 50204

Tulsa, Oklahoma, United States

Site Status

Hs0003 50147

Hershey, Pennsylvania, United States

Site Status

Hs0003 50008

Johnston, Rhode Island, United States

Site Status

Hs0003 50180

Providence, Rhode Island, United States

Site Status

Hs0003 50142

Nashville, Tennessee, United States

Site Status

Hs0003 50201

Arlington, Texas, United States

Site Status

Hs0003 50166

Dallas, Texas, United States

Site Status

Hs0003 50149

San Antonio, Texas, United States

Site Status

Hs0003 50270

Seattle, Washington, United States

Site Status

Hs0003 30015

Campbelltown, , Australia

Site Status

Hs0003 30016

Carlton, , Australia

Site Status

Hs0003 30011

East Melbourne, , Australia

Site Status

Hs0003 30017

Kogarah, , Australia

Site Status

Hs0003 30012

Woolloongabba, , Australia

Site Status

Hs0003 40004

Brussels, , Belgium

Site Status

Hs0003 40121

Brussels, , Belgium

Site Status

Hs0003 40002

Leuven, , Belgium

Site Status

Hs0003 40060

Liège, , Belgium

Site Status

Hs0003 50233

Barrie, , Canada

Site Status

Hs0003 50190

Richmond Hill, , Canada

Site Status

Hs0003 50192

Saskatoon, , Canada

Site Status

Hs0003 50173

St. John's, , Canada

Site Status

Hs0003 50133

Surrey, , Canada

Site Status

Hs0003 40127

Aarhus N, , Denmark

Site Status

Hs0003 40197

Amiens, , France

Site Status

Hs0003 40342

Angers, , France

Site Status

Hs0003 40355

Le Mans, , France

Site Status

Hs0003 40132

Nice, , France

Site Status

Hs0003 40318

Rouen, , France

Site Status

Hs0003 40246

Saint-Mandé, , France

Site Status

Hs0003 40285

Toulon, , France

Site Status

Hs0003 40325

Berlin, , Germany

Site Status

Hs0003 40248

Bochum, , Germany

Site Status

Hs0003 40327

Bonn, , Germany

Site Status

Hs0003 40288

Darmstadt, , Germany

Site Status

Hs0003 40324

Dresden, , Germany

Site Status

Hs0003 40249

Kiel, , Germany

Site Status

Hs0003 40357

Magdeburg, , Germany

Site Status

Hs0003 40174

Mainz, , Germany

Site Status

Hs0003 40323

München, , Germany

Site Status

Hs0003 40177

Münster, , Germany

Site Status

Hs0003 40251

Athens, , Greece

Site Status

Hs0003 40253

Athens, , Greece

Site Status

Hs0003 40252

Thessaloniki, , Greece

Site Status

Hs0003 20089

Haifa, , Israel

Site Status

Hs0003 20088

Tel Aviv, , Israel

Site Status

Hs0003 40261

Catania, , Italy

Site Status

Hs0003 40257

Roma, , Italy

Site Status

Hs0003 40263

Roma, , Italy

Site Status

Hs0003 40258

Rozzano, , Italy

Site Status

Hs0003 40331

Terracina, , Italy

Site Status

Hs0003 40330

Torino, , Italy

Site Status

Hs0003 40351

Breda, , Netherlands

Site Status

Hs0003 40292

Groningen, , Netherlands

Site Status

Hs0003 40264

Rotterdam, , Netherlands

Site Status

Hs0003 40332

Trondheim, , Norway

Site Status

Hs0003 40266

Badalona, , Spain

Site Status

Hs0003 40294

Las Palmas de Gran Canaria, , Spain

Site Status

Hs0003 40295

Pontevedra, , Spain

Site Status

Hs0003 40049

Seville, , Spain

Site Status

Hs0003 40230

Valencia, , Spain

Site Status

Hs0003 40337

Bern, , Switzerland

Site Status

Hs0003 40406

Geneva, , Switzerland

Site Status

Hs0003 40053

Ankara, , Turkey (Türkiye)

Site Status

Hs0003 40270

Antalya, , Turkey (Türkiye)

Site Status

Hs0003 40273

Gaziantep, , Turkey (Türkiye)

Site Status

Hs0003 40050

Istanbul, , Turkey (Türkiye)

Site Status

Hs0003 40272

Istanbul, , Turkey (Türkiye)

Site Status

Hs0003 40271

Izmir, , Turkey (Türkiye)

Site Status

Countries

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United States Australia Belgium Canada Denmark France Germany Greece Israel Italy Netherlands Norway Spain Switzerland Turkey (Türkiye)

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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2019-002550-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HS0003

Identifier Type: -

Identifier Source: org_study_id