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

NCT04242446 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: HS00032019-002550-23
• Study Type: interventional
• Target: 505
• Locations: 15 countries
• Sites: 88

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)

Conditions

Hidradenitis Suppurativa

Keywords

Bimekizumab; UCB4940; HS; Hidradenitis Suppurativa; Acne inversa

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16

  HiSCR50 was defined as at least a 50 percent (%) reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count. Intermittent missing data are imputed using multiple imputation with Markov Chain Monte Carlo (MCMC) method followed by monotone regression for monotone missing data. Lesion counts were imputed and then dichotomized to obtain the response status. Participants who experienced an intercurrent event were treated as nonresponders following the intercurrent event. An intercurrent event was defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to an adverse event (AE) or lack of efficacy. Percentage of participants shown do not account for model effects using the logistic regression model.

  Week 16

Secondary Outcomes (7)

• Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16

  Week 16

• Absolute Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16

  Baseline, Week 16

• Absolute Change From Baseline in Worst Skin Pain Score at Week 16

  Baseline, Week 16

• Percentage of Participants Achieving Worst Skin Pain Response at Week 16

  Week 16

• Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study

  From Baseline (Day 1) until Safety Follow-Up (up to Week 71)

Study Arms (4)

Bimekizumab dosing regimen 1

EXPERIMENTAL

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

Drug: Bimekizumab

Bimekizumab dosing regimen 2

EXPERIMENTAL

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

Drug: Bimekizumab

Bimekizumab dosing regimen 3

EXPERIMENTAL

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

Drug: Bimekizumab

Placebo Group

PLACEBO COMPARATOR

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

Drug: Bimekizumab; Other: Placebo

Interventions

Bimekizumab DRUG

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

Also known as: UCB4940

Bimekizumab dosing regimen 1; Bimekizumab dosing regimen 2; Bimekizumab dosing regimen 3; Placebo Group

Placebo OTHER

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

Also known as: PBO

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Not a woman of childbearing potential (WOCBP) OR
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (88)

Hs0003 50140

Birmingham, Alabama, 35233, United States

Location

Hs0003 50175

Phoenix, Arizona, 85006, United States

Location

Hs0003 50161

Los Angeles, California, 90045, United States

Location

Hs0003 50220

San Diego, California, 92123, United States

Location

Hs0003 50205

North Miami Beach, Florida, 33162-4708, United States

Location

Hs0003 50153

Ormond Beach, Florida, 32174, United States

Location

Hs0003 50141

Tampa, Florida, 33613, United States

Location

Hs0003 50210

Atlanta, Georgia, 30309, United States

Location

Hs0003 50280

Watkinsville, Georgia, 30677, United States

Location

Hs0003 50425

Murray, Kentucky, 42071, United States

Location

Hs0003 50198

Beverly, Massachusetts, 01915, United States

Location

Hs0003 50146

Boston, Massachusetts, 02215, United States

Location

Hs0003 50194

Omaha, Nebraska, 68144, United States

Location

Hs0003 50208

Las Vegas, Nevada, 89148, United States

Location

Hs0003 50137

East Windsor, New Jersey, 08520, United States

Location

Hs0003 50235

New York, New York, 10003, United States

Location

Hs0003 50151

Chapel Hill, North Carolina, 27516, United States

Location

Hs0003 50177

Cincinnati, Ohio, 45219, United States

Location

Hs0003 50138

Columbus, Ohio, 43213, United States

Location

Hs0003 50204

Tulsa, Oklahoma, 74135, United States

Location

Hs0003 50147

Hershey, Pennsylvania, 17033, United States

Location

Hs0003 50008

Johnston, Rhode Island, 02919, United States

Location

Hs0003 50180

Providence, Rhode Island, 02903, United States

Location

Hs0003 50142

Nashville, Tennessee, 37215, United States

Location

Hs0003 50201

Arlington, Texas, 76011, United States

Location

Hs0003 50166

Dallas, Texas, 75246, United States

Location

Hs0003 50149

San Antonio, Texas, 78213, United States

Location

Hs0003 50270

Seattle, Washington, 98101, United States

Location

Hs0003 30015

Campbelltown, Australia

Location

Hs0003 30016

Carlton, Australia

Location

Hs0003 30011

East Melbourne, Australia

Location

Hs0003 30017

Kogarah, Australia

Location

Hs0003 30012

Woolloongabba, Australia

Location

Hs0003 40004

Brussels, Belgium

Location

Hs0003 40121

Brussels, Belgium

Location

Hs0003 40002

Leuven, Belgium

Location

Hs0003 40060

Liège, Belgium

Location

Hs0003 50233

Barrie, Canada

Location

Hs0003 50190

Richmond Hill, Canada

Location

Hs0003 50192

Saskatoon, Canada

Location

Hs0003 50173

St. John's, Canada

Location

Hs0003 50133

Surrey, Canada

Location

Hs0003 40127

Aarhus N, Denmark

Location

Hs0003 40197

Amiens, France

Location

Hs0003 40342

Angers, France

Location

Hs0003 40355

Le Mans, France

Location

Hs0003 40132

Nice, France

Location

Hs0003 40318

Rouen, France

Location

Hs0003 40246

Saint-Mandé, France

Location

Hs0003 40285

Toulon, France

Location

Hs0003 40325

Berlin, Germany

Location

Hs0003 40248

Bochum, Germany

Location

Hs0003 40327

Bonn, Germany

Location

Hs0003 40288

Darmstadt, Germany

Location

Hs0003 40324

Dresden, Germany

Location

Hs0003 40249

Kiel, Germany

Location

Hs0003 40357

Magdeburg, Germany

Location

Hs0003 40174

Mainz, Germany

Location

Hs0003 40323

München, Germany

Location

Hs0003 40177

Münster, Germany

Location

Hs0003 40251

Athens, Greece

Location

Hs0003 40253

Athens, Greece

Location

Hs0003 40252

Thessaloniki, Greece

Location

Hs0003 20089

Haifa, Israel

Location

Hs0003 20088

Tel Aviv, Israel

Location

Hs0003 40261

Catania, Italy

Location

Hs0003 40257

Roma, Italy

Location

Hs0003 40263

Roma, Italy

Location

Hs0003 40258

Rozzano, Italy

Location

Hs0003 40331

Terracina, Italy

Location

Hs0003 40330

Torino, Italy

Location

Hs0003 40351

Breda, Netherlands

Location

Hs0003 40292

Groningen, Netherlands

Location

Hs0003 40264

Rotterdam, Netherlands

Location

Hs0003 40332

Trondheim, Norway

Location

Hs0003 40266

Badalona, Spain

Location

Hs0003 40294

Las Palmas de Gran Canaria, Spain

Location

Hs0003 40295

Pontevedra, Spain

Location

Hs0003 40049

Seville, Spain

Location

Hs0003 40230

Valencia, Spain

Location

Hs0003 40337

Bern, Switzerland

Location

Hs0003 40406

Geneva, Switzerland

Location

Hs0003 40053

Ankara, Turkey (Türkiye)

Location

Hs0003 40270

Antalya, Turkey (Türkiye)

Location

Hs0003 40273

Gaziantep, Turkey (Türkiye)

Location

Hs0003 40050

Istanbul, Turkey (Türkiye)

Location

Hs0003 40272

Istanbul, Turkey (Türkiye)

Location

Hs0003 40271

Izmir, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 40172122 RESULT

• 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.

  PMID: 40153232 RESULT

• 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.

  PMID: 40652434 RESULT

• 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 Dec;14(6):1861-1878. doi: 10.1007/s40122-025-00779-7. Epub 2025 Oct 17.

  PMID: 41107641 RESULT

• Tzellos T, Giamarellos-Bourboulis EJ, van Straalen KR, Martorell A, Kirby B, Alavi A, Hayama K, Khattri S, Gulliver W, Sayed CJ, Davis L, Rolleri RL, Crater C, Pansar I, Lambert J, Zouboulis CC. Bimekizumab efficacy using IHS4 outcomes in hidradenitis suppurativa: Results from BE HEARD I and II. J Eur Acad Dermatol Venereol. 2026 Feb 14. doi: 10.1111/jdv.70356. Online ahead of print.

  PMID: 41689425 RESULT

• Sayed CJ, Kirby B, Garg A, Naik HB, Kimball AB, Zouboulis CC, Jemec GBE, Kokolakis G, Ingram JR, Morita A, Deherder D, Crater C, Rolleri RL, Vaux T, Lambert J, Lukowski B, Bechara FG. Bimekizumab demonstrated a favorable safety profile and high levels of efficacy with up to 2 years of treatment in patients with moderate to severe hidradenitis suppurativa: Pooled results from two phase 3 randomized, controlled trials and their open-label extension. J Am Acad Dermatol. 2026 Mar;94(3):867-878. doi: 10.1016/j.jaad.2025.11.031. Epub 2025 Nov 15.

  PMID: 41248770 RESULT

• 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.

  PMID: 38795716 DERIVED

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

bimekizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 27, 2020
• Study Start: February 19, 2020
• Primary Completion: April 7, 2022
• Study Completion: February 19, 2023
• Last Updated: May 19, 2026
• Results First Posted: January 9, 2025

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

FR (7); AU (5); IL (2); DK (1); GR (3); BE (4); TU (6); CA (5); US (28); ES (5); IT (6); NL (3); NO (1); CH (2); DE (10)