A Phase 3 study to Assess Nemolizumab in Prurigo Nodularis
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects with Prurigo Nodularis
IRAS ID
279972
Contact name
Andrew Pink
Contact email
Sponsor organisation
Galderma S.A.
Eudract number
2019-004293-25
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 7 days
Research summary
Prurigo Nodularis (PN) is a disease associated with the presence of multiple, intensely itchy, and difficult to treat nodules on the skin. Chronic itching is believed to induce and maintain the PN skin lesions through an itch-scratch cycle. This leads to an impaired quality of life and high burden due not only to the severe itch but also the chronic skin lesions and lack of treatment options.
The goal of PN treatment is to break the itch-scratch cycle and allow the skin to heal. Treatment of chronic pruritus (itching) is still notoriously challenging and frustrating for both doctors and patients, as the response to current therapy options is typically limited or associated with adverse events. There is no standardised or approved therapy for PN to date and evidence from controlled studies is limited.
The cause of PN is not yet fully understood, however a protein called Interleukin-31 (IL-31) has been suggested to be a key player in the development of pruritus in PN and thus a potential therapeutic target(Park K, Mori T, Nakamura M, Tokura Y Eur J Dermatol 2011). Galderma S.A, the sponsor of this study, has developed an investigational drug called nemolizumab (CD14152)for the treatment of PN. Nemolizumab is a humanised IL-31 receptor A monoclonal antibody designed to bind to IL-31 and prevent its action.
The purpose of this study is to determine how safe and effective nemolizumab is in patients with PN. Eligible participants will be randomised 1:1 to receive either nemolizumab or placebo via subcutaneous injection every 4 weeks. The study consists of a screening period, a 16-week treatment period, and an 8-week follow up period. Total study participation will be up to 28 weeks.
This is a phase 3, double-blind, placebo-controlled, randomised study that will recruit 240 adult participants with PN at approximately 50 different study sites globally.
REC name
London - City & East Research Ethics Committee
REC reference
20/LO/0731
Date of REC Opinion
25 Jun 2020
REC opinion
Further Information Favourable Opinion