A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy
Topic / Pathology
- Biologic
- interventional
Objectives
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 placebo 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
https://clinicaltrials.gov/study/NCT05958407?term=LP0162-2328&rank=1
Sponsor
LEO Pharma
Investigator
Dr Claire Bernier
Critères d'inclusion
Diagnosis of atopic dermatitis for ≥1 year Presence of atopic hand eczema (AHE) that has persisted for more than 3 months or returned twice or more within the last 12 months, AD involvement of at least one body location other than the hands and wrists at screening, An Investigator's Global Assessment AHE score of 3 or 4 (moderate to severe) at screening and baseline...
Critères de non-inclusion
Subjects must not enter the trial if they have active subtypes of hand eczema other than AHE, Active dermatologic conditions that may confound the diagnosis of AD or AHE...
Status
Ongoing
