Efficacy and safety of dupilumab in patients with prurigo nodularis
Research type
Research Study
Full title
A randomized, double blind, placebo-controlled, multi-center, parallel group study to evaluate the efficacy and safety of dupilumab in patients with prurigo nodularis who are inadequately controlled on topical prescription therapies or when those therapies are not advisable
IRAS ID
273930
Contact name
catherine chene
Contact email
Sponsor organisation
sanofi-aventis recherche & développement
Eudract number
2019-003801-90
Duration of Study in the UK
0 years, 3 months, 1 days
Research summary
Summary of Research
The purpose of the study is to evaluate how effective dupilumab is and how safe it is in reducing the signs and symptoms in patient with prurigo nodularis where the symptoms are not adequately controlled on topical prescription therapy or when use of those therapies are not advisable.
Prurigo nodularis is a skin disease characterized by multiple, intensely itchy skin eruptions in the extremities. The main symptom is prolonged, repetitive and uncontrollable rubbing, scratching and uncontrollable itching which leads to papules and nodules on the skin.
Dupilumab is a fully human monoclonal antibody (a protein) that blocks the activity of interleukin 4 and 13 in the body (interleukins are proteins that stimulate immune response and can cause inflammation).
It is a randomized, double blind, placebo-controlled study and is planned to include approximately 150 participants. Each participant will be involved in the study for approximately 40 weeks.
Participation in the study will involve approximately 7 visits to the research site, plus daily completion of questionnaires on a tablet. After the screening period (2-4 week) participants will be randomised to study drug or placebo which they will receive for up to 24 weeks. After study drug / placebo is stopped participants will be followed-up for another 12 weeks. Assessments during study visits include physical examinations and vital sign checks, electrocardiograms, blood and urine sample collection, completion of questionnaires on a tablet, and administration of study drug or placebo. Most participants will also be expected to administer study drug at home between study visits.
There is the option to consent to collection of additional samples for genetic testing and future research.Summary of Results
Not available as yetREC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
20/NE/0087
Date of REC Opinion
27 Apr 2020
REC opinion
Further Information Favourable Opinion