VELA-OLE
Research type
Research Study
Full title
A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with moderate to severe hidradenitis suppurativa
IRAS ID
1011879
Contact name
Lynsey Kennedy
Contact email
Sponsor organisation
MoonLake Immunotherapeutics AG
Clinicaltrials.gov Identifier
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 perianal area and is characterised by inflammatory nodules, abscesses, draining tunnels and scarring. 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 evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe HS who were previously enrolled in a parent study. Sonelokimab will be administered by subcutaneous (SC) injection by the Molly autoinjector device. Following successful training and supervision, participants (or caregivers) will be asked to use the autoinjector device to self-administer doses of sonelokimab SC at home and at the study centre.
Up to 835 participants may be enrolled.
Study phases:
• Screening – assessments performed at the EOT visit of the parent study
• Treatment phase – 2 years
• Survival follow up visit – 8 weeks after final dose of study treatment
Study procedures will include height/weight, vital signs, physical examinations, blood and urine tests, ECGs, diaries and questionnaires and lesion counts.REC name
East Midlands - Derby Research Ethics Committee
REC reference
25/EM/0179
Date of REC Opinion
8 Sep 2025
REC opinion
Further Information Favourable Opinion