ADHAND
Research type
Research Study
Full title
A phase 3b, interventional, adaptive, clinical trial to evaluate the efficacy and safety of tralokinumab 300 mg every second week monotherapy compared with placebo in subjects with moderate-to-severe atopic hand eczema who are candidates for systemic therapy (ADHAND)
IRAS ID
1007484
Contact name
Anita Ilievska Silva
Contact email
Sponsor organisation
LEO Pharma A/S
Eudract number
2022-502653-34
Research summary
The purpose of this study is to test if treatment with tralokinumab is safe and effectful to treat moderate-to-severe atopic hand eczema. This will be judged by a range of assessments that rate the severity and extent of atopic hand eczema and its symptoms, as well as general health status and quality of life.
The trial will last for up to 40 weeks. There will be up to 15 visits, 3 of which will be conducted by phone. The first part of the trial is called a screening period and will last up to 4 weeks. For the first 16 weeks after screening, trial participants will receive either tralokinumab or dummy injections every two weeks. After the first 16 weeks, all trial participants will receive tralokinumab injections every two weeks for 16 weeks. The last part of the trial is a period of 4 weeks after the end of treatment period, where trial participants are off the drug
for safety follow-up.REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0178
Date of REC Opinion
15 Sep 2023
REC opinion
Further Information Favourable Opinion