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

Hidradenitis Suppurativa Clinical Trial

— BE HEARD I  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04242446
• Other study ID #: HS0003
• Secondary ID: 2019-002550-23
• Status: Completed
• Phase: Phase 3
• Start date: February 19, 2020
• Est. completion date: February 19, 2023

Study information

• Verified date: March 2024
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 505
• Est. completion date: February 19, 2023
• Est. primary completion date: April 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

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

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

Locations

Country	Name	City	State
Australia	Hs0003 30015	Campbelltown
Australia	Hs0003 30016	Carlton
Australia	Hs0003 30011	East Melbourne
Australia	Hs0003 30017	Kogarah
Australia	Hs0003 30012	Woolloongabba
Belgium	Hs0003 40004	Brussels
Belgium	Hs0003 40121	Bruxelles
Belgium	Hs0003 40002	Leuven
Belgium	Hs0003 40060	Liege
Canada	Hs0003 50233	Barrie
Canada	Hs0003 50190	Richmond Hill
Canada	Hs0003 50192	Saskatoon
Canada	Hs0003 50173	St. John's
Canada	Hs0003 50133	Surrey
Denmark	Hs0003 40127	Aarhus N
France	Hs0003 40197	Amiens Cedex 1
France	Hs0003 40342	Angers
France	Hs0003 40355	Le Mans
France	Hs0003 40132	Nice
France	Hs0003 40318	Rouen Cedex
France	Hs0003 40246	Saint Mandé
France	Hs0003 40285	Toulon
Germany	Hs0003 40325	Berlin
Germany	Hs0003 40248	Bochum
Germany	Hs0003 40327	Bonn
Germany	Hs0003 40288	Darmstadt
Germany	Hs0003 40324	Dresden
Germany	Hs0003 40249	Kiel
Germany	Hs0003 40357	Magdeburg
Germany	Hs0003 40174	Mainz
Germany	Hs0003 40323	München
Germany	Hs0003 40177	Münster
Greece	Hs0003 40251	Athens
Greece	Hs0003 40253	Athens
Greece	Hs0003 40252	Thessaloniki
Israel	Hs0003 20089	Haifa
Israel	Hs0003 20088	Tel Aviv
Italy	Hs0003 40261	Catania
Italy	Hs0003 40257	Roma
Italy	Hs0003 40263	Roma
Italy	Hs0003 40258	Rozzano
Italy	Hs0003 40331	Terracina
Italy	Hs0003 40330	Torino
Netherlands	Hs0003 40351	Breda
Netherlands	Hs0003 40292	Groningen
Netherlands	Hs0003 40264	Rotterdam
Norway	Hs0003 40332	Trondheim
Spain	Hs0003 40266	Badalona
Spain	Hs0003 40294	Las Palmas de Gran Canaria
Spain	Hs0003 40295	Pontevedra
Spain	Hs0003 40049	Sevilla
Spain	Hs0003 40230	Valencia
Switzerland	Hs0003 40337	Bern
Switzerland	Hs0003 40406	Genève
Turkey	Hs0003 40053	Ankara
Turkey	Hs0003 40270	Antalya
Turkey	Hs0003 40273	Gaziantep
Turkey	Hs0003 40271	I?zmir
Turkey	Hs0003 40050	Istanbul
Turkey	Hs0003 40272	Istanbul
United States	Hs0003 50201	Arlington	Texas
United States	Hs0003 50210	Atlanta	Georgia
United States	Hs0003 50198	Beverly	Massachusetts
United States	Hs0003 50140	Birmingham	Alabama
United States	Hs0003 50146	Boston	Massachusetts
United States	Hs0003 50151	Chapel Hill	North Carolina
United States	Hs0003 50177	Cincinnati	Ohio
United States	Hs0003 50138	Columbus	Ohio
United States	Hs0003 50166	Dallas	Texas
United States	Hs0003 50137	East Windsor	New Jersey
United States	Hs0003 50147	Hershey	Pennsylvania
United States	Hs0003 50008	Johnston	Rhode Island
United States	Hs0003 50208	Las Vegas	Nevada
United States	Hs0003 50161	Los Angeles	California
United States	Hs0003 50425	Murray	Kentucky
United States	Hs0003 50142	Nashville	Tennessee
United States	Hs0003 50235	New York	New York
United States	Hs0003 50205	North Miami Beach	Florida
United States	Hs0003 50194	Omaha	Nebraska
United States	Hs0003 50153	Ormond Beach	Florida
United States	Hs0003 50175	Phoenix	Arizona
United States	Hs0003 50180	Providence	Rhode Island
United States	Hs0003 50149	San Antonio	Texas
United States	Hs0003 50220	San Diego	California
United States	Hs0003 50270	Seattle	Washington
United States	Hs0003 50141	Tampa	Florida
United States	Hs0003 50204	Tulsa	Oklahoma
United States	Hs0003 50280	Watkinsville	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at 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.	Week 16
Secondary	Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at 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.	Week 16
Secondary	Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at 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.	From Baseline (Day 1) to Week 16
Secondary	Absolute change from Baseline in Skin Pain score at 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).	From Baseline (Day 1) to Week 16
Secondary	Percentage of participants achieving Skin Pain response at 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.	From Baseline (Day 1) to Week 16
Secondary	Percentage of participants with treatment-emergent adverse events (TEAEs) during the study	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 Safety Follow-Up (up to Week 71)
Secondary	Percentage of participants with serious treatment-emergent adverse events during the study	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 Safety Follow-Up (up to Week 71)
Secondary	Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study	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 Safety Follow-Up (up to Week 71)