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 II  

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: NCT04242498
• Other study ID #: HS0004
• Secondary ID: 2019-002551-42
• Status: Completed
• Phase: Phase 3
• Start date: March 2, 2020
• Est. completion date: September 28, 2022

Study information

• Verified date: October 2023
• 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: 509
• Est. completion date: September 28, 2022
• Est. primary completion date: November 9, 2021
• 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 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	Hs0004 30018	Parkville
Australia	Hs0004 30014	St Leonards
Australia	Hs0004 30009	Westmead
Bulgaria	Hs0004 40313	Pleven
Bulgaria	Hs0004 40284	Sofia
Bulgaria	Hs0004 40311	Sofia
Bulgaria	Hs0004 40314	Sofia
Bulgaria	Hs0004 40315	Sofia
Bulgaria	Hs0004 40353	Stara Zagora
Canada	Hs0004 50172	Cobourg
Canada	Hs0004 50135	Edmonton
Canada	Hs0004 50174	London
Canada	Hs0004 50189	St. John's
Canada	Hs0004 50134	Waterloo
Canada	Hs0004 50136	Winnipeg
Czechia	Hs0004 40194	Praha 10
Czechia	Hs0004 40063	Praha 5
France	Hs0004 40245	Antony
France	Hs0004 40321	Auxerre
France	Hs0004 40129	Bordeaux Cedex
France	Hs0004 40320	La Rochelle
France	Hs0004 40247	Lyon
France	Hs0004 40130	Marseille
France	Hs0004 40404	Reims
France	Hs0004 40403	Saint-etienne
France	Hs0004 40286	Toulouse
Germany	Hs0004 40289	Berlin
Germany	Hs0004 40326	Berlin
Germany	Hs0004 40322	Dessau
Germany	Hs0004 40356	Dresden
Germany	Hs0004 40287	Frankfurt/main
Germany	Hs0004 40142	Hamburg
Germany	Hs0004 40328	Hannover
Germany	Hs0004 40250	Lübeck
Hungary	Hs0004 40254	Debrecen
Ireland	Hs0004 40344	Dublin
Israel	Hs0004 20090	Afula
Japan	Hs0004 20196	Bunkyo-ku
Japan	Hs0004 20144	Fukuoka
Japan	Hs0004 20043	Itabashi-ku
Japan	Hs0004 20195	Kagoshima
Japan	Hs0004 20170	Kurume
Japan	Hs0004 20190	Kyoto
Japan	Hs0004 20033	Nagoya
Japan	Hs0004 20152	Nakagami-gun
Japan	Hs0004 20178	Nishinomiya
Japan	Hs0004 20153	Obihiro
Japan	Hs0004 20037	Osaka
Japan	Hs0004 20154	Sapporo
Japan	Hs0004 20171	Sendai
Poland	Hs0004 40347	Lodz
Poland	Hs0004 40293	Rzeszow
Poland	Hs0004 40335	Warszawa
Poland	Hs0004 40095	Wroclaw
Poland	Hs0004 40333	Wroclaw
Poland	Hs0004 40334	Wroclaw
Spain	Hs0004 40159	Barcelona
Spain	Hs0004 40267	Barcelona
Spain	Hs0004 40298	Granada
Spain	Hs0004 40268	Madrid
Spain	Hs0004 40297	Manises
Spain	Hs0004 40101	Sabadell
United Kingdom	Hs0004 40300	Cardiff
United Kingdom	Hs0004 40339	Leeds
United Kingdom	Hs0004 40113	London
United Kingdom	Hs0004 40240	Newcastle Upon Tyne
United Kingdom	Hs0004 40338	Northampton
United States	Hs0004 50237	Albuquerque	New Mexico
United States	Hs0004 50178	Clarkston	Michigan
United States	Hs0004 50145	Columbus	Ohio
United States	Hs0004 50211	Durham	North Carolina
United States	Hs0004 50202	Fairborn	Ohio
United States	Hs0004 50162	Fountain Valley	California
United States	Hs0004 50236	Greenville	South Carolina
United States	Hs0004 50197	Henderson	Nevada
United States	Hs0004 50084	Johns Island	South Carolina
United States	Hs0004 50199	Miami	Florida
United States	Hs0004 50152	Orange Park	Florida
United States	Hs0004 50144	Orlando	Florida
United States	Hs0004 50184	Pembroke Pines	Florida
United States	Hs0004 50148	Pflugerville	Texas
United States	Hs0004 50150	Philadelphia	Pennsylvania
United States	Hs0004 50234	Plainfield	Indiana
United States	Hs0004 50159	Portsmouth	New Hampshire
United States	Hs0004 50105	Saint Louis	Missouri
United States	Hs0004 50193	Sandy Springs	Georgia
United States	Hs0004 50223	Savannah	Georgia
United States	Hs0004 50164	Skokie	Illinois
United States	Hs0004 50196	Thousand Oaks	California
United States	Hs0004 50200	Verona	New Jersey
United States	Hs0004 50179	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

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

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	Percentage of participants with Flare by Week 16	Flare is defined as a =25% increase in AN count with an absolute increase in AN count of =2 relative to Baseline.	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)