Sonelokimab in adults with HS: VELA-1
Research type
Research Study
Full title
A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of subcutaneous sonelokimab in adult participants with moderate to severe hidradenitis suppurativa.
IRAS ID
1010062
Contact name
Kristian Reich
Contact email
Sponsor organisation
MoonLake Immunotherapeutics AG
Research summary
Hidradenitis suppurativa (HS) is a chronic, inflammatory, recurrent debilitating skin disease that usually presents in early
adulthood. Risk factors include family history, with 34% of first-degree relatives (parents, siblings or children) being affected. Additional risks are smoking and obesity. HS manifests as painful inflammatory skin lesions primarily in the armpits, groin, buttocks, and in the anal area and is characterised by inflammatory nodules and abscesses.
HS occurs in around 1% of the adult population. Currently, treatment options are limited and there is a significant unmet need for new therapies.
Sonelokimab is a nanobody. Nanobody molecules are a type of miniature antibody that recognises other proteins in the body and specifically bind to them. Sonelokimab belongs to a group of medicines called interleukin (IL) inhibitors which work on the immune system to reduce inflammation and other symptoms. Sonelokimab works by inhibiting the activity of two inflammatory interleukin proteins called IL-17A and IL-17F, which are present at increased levels in HS. The purpose of this study is to determine if sonelokimab is effective in reducing the signs and symptoms of HS in people with moderate to severe disease, compared to placebo (an inactive substance that looks like the study drug being tested).
Participants will be in this study for about 52 weeks. Following the screening phase, which will last between 7 and 28 days there will be 2 treatment phases. During the first treatment phase, which will last for 16 weeks, participants will be randomly assigned to receive either sonelokimab or placebo. After 16 weeks the second treatment phase will begin and all participants who had been receiving placebo will switch so that all participants are receiving sonelokimab for the duration of the second treatment period of 32 weeks.
Study procedures will include blood and urine tests, physical examinations, ECGs, vital signs and diary and questionnaire completion.REC name
Wales REC 5
REC reference
24/WA/0147
Date of REC Opinion
1 Jul 2024
REC opinion
Further Information Favourable Opinion