BE HEARD II
Research type
Research Study
Full 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
IRAS ID
1003010
Contact name
J R Ingram
Contact email
Eudract number
2019-002551-42
Research summary
Hidradenitis suppurativa (HS) is a persistent, recurring, inflammatory skin disease that
usually presents after puberty. It is characterised by deep, painful, inflamed lesions
(nodules) in the apocrine (sweat) gland-bearing areas of the body; most commonly the
armpits, groin, and around the genitals. These lesions can swell and become infected to
form abscesses (open wounds), and may rupture and cause scarring. Many patients with
HS develop long lasting damage that can only be fixed by surgery to remove the damaged
areas of skin. Fistulas and scarring can permanently damage internal structures of the
groin (such as anus and urethra) and can limit mobility.
HS is estimated to affect about 1% of the adult European population, with women three
times more likely to suffer from the disease than men. People with HS have a significantly
reduced quality of life due to the location of lesions and associated discharge and pain.
The reduction in quality of life is comparable to, or greater than, that of heart disease,
diabetes and asthma.
Current treatments for HS include topical treatments, anti-inflammatory medications,
antibiotics and pain management medication; but these are often ineffective and do not
provide long-lasting relief. There is currently no cure for HS.
Bimekizumab is an engineered humanised antibody (immune system protein) which binds
to IL-17A and IL-17F. IL-17 is a molecule which is released by the immune system and
causes inflammation. In HS too much IL-17 is released causing the symptoms of HS.
Bimekizumab binds to (“mops-up”) the excessive IL-17A and IL-17F, and previous
studies suggest that this can reduce inflammation and subsequent HS symptoms.
The purpose of this study is to confirm the safety and effectiveness of Bimekizumab.
This study aims to recruit 490 participants across approximately 110 hospitals
worldwide. The Sponsor for this study is UCB Biopharma SRL.Summary of Results
UCB will be providing plain language summaries of all UCB-sponsored clinical trials conducted in the UK that end in 2022 and beyond on UCB.com.
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: Results are planned to be added on 28th of September but will not be publicly available until reviewed by the PRS team. This is currently not showing yet.
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Pending
If yes, describe or provide URLs to disseminated materials:
If pending, date when dissemination is expected: 29/12/2023
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: Pending
If yes, describe and/or provide URLs to materials shared and how they were shared:
If pending, date when feedback is expected: 29/12/2023
If no, explain why they haven't:
Have you enabled sharing of study data with others?: No
If yes, describe or provide URLs to how it has been shared:
If no, explain why sharing hasn't been enabled: UCB Policy is to share individual patient level data with qualified researchers 18 months after marketing authorization in the EU and US or global discontinuation of development and 6 months after the trial ends.
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL:
If no, explain why: Sharing tissue samples is outside of UCB’s Data Sharing Policy
Submitted on: 27/10/2023REC name
London - Surrey Borders Research Ethics Committee
REC reference
20/LO/0453
Date of REC Opinion
28 Apr 2020
REC opinion
Further Information Favourable Opinion