BE HEARD EXTENSION
Research type
Research Study
Full 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
IRAS ID
1003865
Contact name
Brittany Reich
Contact email
Sponsor organisation
UCB Biopharma SRL
Eudract number
2020-004179-42
Clinicaltrials.gov Identifier
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 (i.e., anus and urethra) and can limit mobility.
HS is estimated to affect ~1% of the adult European population, with women 3 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 test the long-term treatment of Bimekizumab in study participants with moderate to severe HS. This study will involve ~830 participants across ~200 sites throughout Europe including UK, North America, Asia/Australia and Middle East. The Sponsor for this study is UCB Biopharma SRL.REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0311
Date of REC Opinion
19 Oct 2021
REC opinion
Further Information Favourable Opinion