Tralokinumab for Atopic Hand Eczema
(ADHAND Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
Yes, you may need to stop certain medications. The trial requires stopping some treatments like systemic immunosuppressive drugs, corticosteroids, and certain topical treatments before starting the trial.
What data supports the effectiveness of the drug Tralokinumab for treating atopic hand eczema?
Tralokinumab has been shown to be effective in treating moderate-to-severe atopic dermatitis, a similar skin condition, by improving symptoms and quality of life in clinical trials. It works by targeting and neutralizing interleukin-13, a protein involved in inflammation, and has been approved for use in adults with atopic dermatitis.12345
Is Tralokinumab safe for humans?
How is the drug Tralokinumab unique for treating atopic hand eczema?
Tralokinumab is unique because it is a monoclonal antibody that specifically targets and neutralizes interleukin-13, a protein involved in inflammation, which is different from traditional treatments like topical corticosteroids. This targeted approach may offer a new option for patients with atopic hand eczema, especially those who need systemic therapy.12345
Research Team
Medical Expert
Principal Investigator
LEO Pharma
Eligibility Criteria
Adults over 18 with moderate-to-severe atopic hand eczema, unresponsive to or unsuitable for topical treatments, and a history of atopic dermatitis. Participants must have had eczema on their hands for more than 3 months or recurrent episodes and other body areas affected. They should not have used certain therapies before joining the trial.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment (Double-blinded)
Participants receive either tralokinumab or placebo injections every two weeks
Treatment (Open-label)
All participants receive tralokinumab injections every two weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Tralokinumab
Tralokinumab is already approved in United States, European Union, Canada for the following indications:
- Moderate-to-severe atopic dermatitis
- Moderate-to-severe atopic dermatitis
- Moderate-to-severe atopic dermatitis
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Who Is Running the Clinical Trial?
LEO Pharma
Lead Sponsor
Christophe Bourdon
LEO Pharma
Chief Executive Officer since 2022
Engineering degree from Université de Technologie de Compiègne
Dr. Siri Torhaug
LEO Pharma
Chief Medical Officer since 2022
MD, PhD