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Clinical trial

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 (ADHAND)

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Last updated:10th Jun 2024
Status: RECRUITING
Identifier: NCT05958407
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 (ADHAND)

ClinicalTrials.gov ID: NCT05958407
Sponsor: LEO Pharma
Information provided by: LEO Pharma (Responsible Party)
Last Update Posted: 2024-06-04

Brief 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.

Official 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

Intervention / Treatment: 
- Drug: Tralokinumab
- Drug: Placebo

Category Value
Study Start (Actual) 2023-08-28
Primary Completion (Estimated) 2026-11-01
Study Completion (Estimated) 2027-03-22
Enrollment (Estimated) 402
Study Type Interventional
Phase Phase 3
Other Study ID Numbers
LP0162-2328

U1111-1285-7014 (Other Identifier) (OTHER: World Health Organization (WHO))

2022-502653-34-00 (Other Identifier) (OTHER: European Medicines Agency (EMA))


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