RE-UNITE-AD
Research type
Research Study
Full title
Real-world Experience Using Nemolizumab in the Treatment of Moderate-to-Severe Atopic Dermatitis in Adolescents & Adults
IRAS ID
359020
Contact name
Liliana Ulianov
Contact email
Sponsor organisation
Galderma S.A.
Duration of Study in the UK
2 years, 1 months, 17 days
Research summary
This is a non-interventional study to evaluate the use of Nemolizumab in the treatment of moderate to severe Atopic Dermatitis (AD) in Adults and Children. The sponsor conducting this study is Galderma.
Atopic Dermatitis (AD), also known as Eczema is a long-lasting skin condition that causes inflammation of the skin and really affects a person's quality of life. One of the biggest problems is the constant itching, which makes people scratch their skin, causing irritation and inflammation of the skin. A substance in the body called interleukin-31 (or IL-31) plays a big role in causing AD.
The aim of this study is to observe how Nemolizumab impacts AD in everyday life, based on doctors evaluations of up to 12 months, to evaluate the change in overall health and to evaluate the side effects that are serious and related to the use of Nemolizumab.
Approximately 1000 participants (both adults and children) will take part in this research study at about 200 study sites in Europe and North America, with a 12-month observation period. Unlike traditional clinical trials, the treatment will be prescribed based on participants regular clinical care, meaning no additional tests or procedures beyond routine practice will be required.
A sub-study will be completed in Germany and UK and will include daily assessments of itch, pain, sleep disturbance, and overall symptoms using numerical rating scales (NRS). Data collection will occur remotely, and no clinic visits will be required.REC name
Wales REC 6
REC reference
25/WA/0232
Date of REC Opinion
21 Aug 2025
REC opinion
Favourable Opinion