A Phase 3 Long Term Study to Assess Nemolizumab in Prurigo Nodularis
Research type
Research Study
Full title
A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Prurigo Nodularis
IRAS ID
281697
Contact name
Michael Graeber
Contact email
Sponsor organisation
Galderma S.A.
Eudract number
2019-004294-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 16 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. 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.
This Long Term Extension study is to determine safety and effectiveness of nemolizumab in 400 patients with PN from previous nemolizumab studies. The study will last up to 64 weeks.
Patients enrolled from the phase 2a study will receive 2 injections on Day 1 of 30mg nemolizumab. After which, patients will receive open-label nemolizumab (1 or 2 injections of 30mg every 4 weeks until Week 48 based on Baseline weight).
Patients enrolled from a phase 3 study will receive 2 injections on Day 1 to maintain the blind of the lead-in study (2 x 30mg nemolizumab / 1 x 30mg nemolizumab and 1 x placebo). After which, patients will receive open-label nemolizumab (1 or 2 injections of 30mg every 4 weeks until Week 48 based on Baseline weight in the phase 3 study).
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
20/EE/0239
Date of REC Opinion
10 Dec 2020
REC opinion
Further Information Favourable Opinion