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Clinical Disclosure (+1) 8775571168
disclosure@leo-pharma.com


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Be Part of Research - Trial Details - 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
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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

Recruiting

Open to: ALL

Age: 18.0 - N/A

Dudley Salford Middlesborough London

Medical Conditions

Dermatitis
Eczema

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Aug 2023 Nov 2026

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants are administered a dose of 300 mg every two weeks for 32 weeks

Intervention Arm Group : Tralokinumab;

Intervention Type : DRUG
Intervention Description : After a loading dose under the skin (s.c.) at baseline, trial participants are administered a placebo dose every two weeks for 16 weeks

Intervention Arm Group : Placebo + tralokinumab;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • LEO Pharma Investigational Site
    Dudley
    West Midlands
    DY1 2HQ
  • LEO Pharma Investigational Site
    Salford
    Greater Manchester
  • LEO Pharma Investigational Site
    Middlesborough
    North Yorkshire
    TS4 3BW
  • LEO Pharma Investigational Site
    London
    SE1 7EH

Clinical Disclosure (+1) 8775571168
disclosure@leo-pharma.com



The study is sponsored by LEO Pharma



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Read full details for Trial ID: NCT05958407
Last updated 21 February 2025

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