A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

— BE HEARD EXT  

Official title:

A Phase 3, Open-Label, Parallel Group, Multicenter, Extension Study Evaluating the Long-Term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04901195
• Other study ID #: HS0005
• Secondary ID: 2020-004179-42
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 27, 2021
• Est. completion date: July 28, 2026

Study information

• Verified date: April 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 safety of long-term therapy of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 658
• Est. completion date: July 28, 2026
• Est. primary completion date: July 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Study participant has completed the Maintenance Treatment Period through Week 48 in HS0003 (NCT04242446) or HS0004 (NCT04242498), was eligible to receive bimekizumab at the time of completing the feeder study, and did not meet any withdrawal criteria of the feeder study
• Study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the Investigator
• 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 open-label extension period and for at least 20 weeks after the final dose of investigational medicinal product (IMP)

Exclusion Criteria:

• Female study participant 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)
• Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments Note: For any study participant with an ongoing serious adverse event (SAE) from HS0003 (NCT04242446) or HS0004 (NCT04242498), or any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry or a history of serious infections in HS0003 or HS0004, the Medical Monitor must be consulted prior to the study participant's entry into HS0005, although the decision on whether to enroll the participant remains with the Investigator.
• Study participant has a positive or indeterminate interferon-gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated
• Study participant has ongoing or planned use of prohibited hidradenitis suppurativa (HS) or non-HS treatment
• Study participant plans to participate in another study of a medicinal product or device under investigation during this study

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

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

Locations

Country	Name	City	State
Australia	Hs0005 30015	Campbelltown
Australia	Hs0005 30016	Carlton
Australia	Hs0005 30011	East Melbourne
Australia	Hs0005 30017	Kogarah
Australia	Hs0005 30018	Parkville
Australia	Hs0005 30014	St Leonards
Australia	Hs0005 30009	Westmead
Australia	Hs0005 30012	Woolloongabba
Belgium	Hs0005 40002	Leuven
Belgium	Hs0005 40121	Woluwe-saint-lambert
Bulgaria	Hs0005 40313	Pleven
Bulgaria	Hs0005 40284	Sofia
Bulgaria	Hs0005 40311	Sofia
Bulgaria	Hs0005 40314	Sofia
Bulgaria	Hs0005 40315	Sofia
Bulgaria	Hs0005 40353	Stara Zagora
Canada	Hs0005 50233	Barrie
Canada	Hs0005 50172	Cobourg
Canada	Hs0005 50135	Edmonton
Canada	Hs0005 50174	London
Canada	Hs0005 50190	Richmond Hill
Canada	Hs0005 50192	Saskatoon
Canada	Hs0005 50133	Surrey
Canada	Hs0005 50134	Waterloo
Canada	Hs0005 50136	Winnipeg
Czechia	Hs0005 40194	Praha 10
Czechia	Hs0005 40063	Praha 5
France	Hs0005 40197	Amiens Cedex
France	Hs0005 40245	Antony
France	Hs0005 40321	Auxerre
France	Hs0005 40320	La Rochelle
France	Hs0005 40355	Le Mans
France	Hs0005 40247	Lyon
France	Hs0005 40130	Marseille
France	Hs0005 40132	Nice
France	Hs0005 40404	Reims
France	Hs0005 40318	Rouen Cedex
France	Hs0005 40246	Saint Mandé
France	Hs0005 40403	Saint-etienne
France	Hs0005 40285	Toulon
France	Hs0005 40286	Toulouse
Germany	Hs0005 40325	Berlin
Germany	Hs0005 40326	Berlin
Germany	Hs0005 40248	Bochum
Germany	Hs0005 40327	Bonn
Germany	Hs0005 40288	Darmstadt
Germany	Hs0005 40324	Dresden
Germany	Hs0005 40356	Dresden
Germany	Hs0005 40287	Frankfurt/main
Germany	Hs0005 40142	Hamburg
Germany	Hs0005 40328	Hannover
Germany	Hs0005 40249	Kiel
Germany	Hs0005 40250	Lübeck
Germany	Hs0005 40174	Mainz
Germany	Hs0005 40323	München
Germany	Hs0005 40177	Münster
Greece	Hs0005 40251	Athens
Greece	Hs0005 40252	Thessaloniki
Hungary	Hs0005 40254	Debrecen
Ireland	Hs0005 40344	Dublin
Italy	Hs0005 40261	Catania
Italy	Hs0005 40263	Roma
Italy	Hs0005 40258	Rozzano
Italy	Hs0005 40330	Turin
Japan	Hs0005 20196	Bunkyo-ku
Japan	Hs0005 20144	Fukuoka
Japan	Hs0005 20043	Itabashi-ku
Japan	Hs0005 20195	Kagoshima
Japan	Hs0005 20170	Kurume
Japan	Hs0005 20190	Kyoto
Japan	Hs0005 20033	Nagoya
Japan	Hs0005 20152	Nakagami-gun
Japan	Hs0005 20178	Nishinomiya
Japan	Hs0005 20153	Obihiro
Japan	Hs0005 20037	Osaka
Japan	Hs0005 20154	Sapporo
Japan	Hs0005 20171	Sendai
Netherlands	Hs0005 40351	Breda
Netherlands	Hs0005 40292	Groningen
Netherlands	Hs0005 40264	Rotterdam
Poland	Hs0005 40347	Lodz
Poland	Hs0005 40293	Rzeszow
Poland	Hs0005 40335	Warszawa
Poland	Hs0005 40095	Wroclaw
Poland	Hs0005 40333	Wroclaw
Poland	Hs0005 40334	Wroclaw
Spain	Hs0005 40266	Badalona
Spain	Hs0005 40159	Barcelona
Spain	Hs0005 40267	Barcelona
Spain	Hs0005 40298	Granada
Spain	Hs0005 40294	Las Palmas de Gran Canaria
Spain	Hs0005 40268	Madrid
Spain	Hs0005 40297	Manises
Spain	Hs0005 40295	Pontevedra
Spain	Hs0005 40049	Sevilla
Spain	Hs0005 40230	Valencia
Switzerland	Hs0005 40406	Genève
Turkey	Hs0005 40270	Antalya
Turkey	Hs0005 40273	Gaziantep
Turkey	Hs0005 40271	I?zmir
Turkey	Hs0005 40272	Istanbul
United Kingdom	Hs0005 40339	Leeds
United States	Hs0005 50237	Albuquerque	New Mexico
United States	Hs0005 50201	Arlington	Texas
United States	Hs0005 50198	Beverly	Massachusetts
United States	Hs0005 50140	Birmingham	Alabama
United States	Hs0005 50146	Boston	Massachusetts
United States	Hs0005 50151	Chapel Hill	North Carolina
United States	Hs0005 50084	Charleston	South Carolina
United States	Hs0005 50177	Cincinnati	Ohio
United States	Hs0005 50178	Clarkston	Michigan
United States	Hs0005 50138	Columbus	Ohio
United States	Hs0005 50145	Columbus	Ohio
United States	Hs0005 50211	Durham	North Carolina
United States	Hs0005 50137	East Windsor	New Jersey
United States	Hs0005 50202	Fairborn	Ohio
United States	Hs0005 50162	Fountain Valley	California
United States	Hs0005 50236	Greenville	South Carolina
United States	Hs0005 50147	Hershey	Pennsylvania
United States	Hs0005 50008	Johnston	Rhode Island
United States	Hs0005 50208	Las Vegas	Nevada
United States	Hs0005 50161	Los Angeles	California
United States	Hs0005 50199	Miami	Florida
United States	Hs0005 50425	Murray	Kentucky
United States	Hs0005 50142	Nashville	Tennessee
United States	Hs0005 50235	New York	New York
United States	Hs0005 50205	North Miami Beach	Florida
United States	Hs0005 50194	Omaha	Nebraska
United States	Hs0005 50152	Orange Park	Florida
United States	Hs0005 50184	Pembroke Pines	Florida
United States	Hs0005 50148	Pflugerville	Texas
United States	Hs0005 50175	Phoenix	Arizona
United States	Hs0005 50234	Plainfield	Indiana
United States	Hs0005 50159	Portsmouth	New Hampshire
United States	Hs0005 50180	Providence	Rhode Island
United States	Hs0005 50105	Saint Louis	Missouri
United States	Hs0005 50220	San Diego	California
United States	Hs0005 50193	Sandy Springs	Georgia
United States	Hs0005 50270	Seattle	Washington
United States	Hs0005 50141	Tampa	Florida
United States	Hs0005 50196	Thousand Oaks	California
United States	Hs0005 50204	Tulsa	Oklahoma
United States	Hs0005 50200	Verona	New Jersey
United States	Hs0005 50280	Watkinsville	Georgia
United States	Hs0005 50179	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  Canada,  Czechia,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Japan,  Netherlands,  Poland,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 end of Safety Follow-Up (up to Week 196)
Secondary	Percentage of participants with treatment-emergent serious adverse events (SAEs) 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 end of Safety Follow-Up (up to Week 196)
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 end of Safety Follow-Up (up to Week 196)
Secondary	Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)	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.; Results will be presented individually per week listed under time points.	Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
Secondary	Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)	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.; Results will be presented individually per week listed under time points.	Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
Secondary	Percentage of participants with Flare	Flare is defined as a =25 % increase in abscess and inflammatory nodule (AN) count with an absolute increase in AN count of =2 relative to Baseline.; Results will be presented individually per week listed under time points.	Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
Secondary	Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) Response for Worst Pain	The 4 items on the HSSQ assess the study participant's perception of the core symptoms of HS experienced in the past 7 days - pain, smell or odor, drainage or oozing from HS lesions, and itch on an 11-point numeric rating scale with higher scores indicating higher symptom level.; Results will be presented individually per week listed under time points.	Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
Secondary	Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score	The DLQI is a skin disease specific questionnaire aimed at the evaluation of how the disease affects participants health related quality of life (QOL). The DLQI total score ranges from 0 to 30 with higher scores indicating higher skin disease impact on QOL.; Results will be presented individually per week listed under time points.	Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180