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

Launched by LEO PHARMA · Jul 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called tralokinumab for people with moderate-to-severe atopic hand eczema, a skin condition that causes dry, itchy, and inflamed skin on the hands. The goal is to find out if this treatment is safe and effective in improving symptoms and overall quality of life for those who have struggled with this condition for a long time. To participate, individuals must be at least 18 years old and have had a diagnosis of atopic dermatitis for at least a year, with persistent hand eczema for over three months.

Participants in the trial will visit the clinic up to 15 times over approximately 40 weeks, including some phone check-ins. They will first receive either tralokinumab or a placebo (a dummy injection) for 16 weeks, and then everyone will continue with tralokinumab for another 16 weeks. After treatment, there will be a 4-week follow-up period to monitor safety. This trial provides a chance for those who haven't found relief with current treatments to explore a potential new option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 years or above at screening
• • Diagnosis of atopic dermatitis (AD) as by the Hanifin and Rajka (1980) criteria for AD
• • History of AD 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, with avoidance of any known and relevant irritants and allergens
• • 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
• • A HESD itch score (weekly average) of ≥4 at baseline
• • Subjects who have a documented recent history (within 12 months before the screening visit) of inadequate response to treatment of AHE with topical prescription medications or for whom topical treatments are otherwise medically inadvisable (e.g., due to important side effects or safety risks)
• Exclusion Criteria:
• * Subjects must not enter the trial if they have active subtypes of hand eczema other than AHE that are considered to be the predominant cause of the current hand eczema including:
• • Active irritant contact dermatitis
• • Active allergic contact dermatitis
• • Active protein contact dermatitis/contact urticaria
• • Active hyperkeratotic hand eczema
• • Active vesicular hand eczema (pompholyx)
• • Active dermatologic conditions that may confound the diagnosis of AD or AHE, or that would interfere with the assessment of treatment
• • Use of tanning beds or phototherapy (e.g., UVB, UVA1, PUVA), or Grenz ray therapy on the hands or wrists within 28 days prior to baseline or use of bleach baths on the hands or wrists within 7 days prior to baseline
• • Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 28 days prior to baseline
• • Treatment with topical corticosteroids, topical calcineurin inhibitors, topical phosphodiesterase 4 inhibitors, or topical Janus kinase inhibitors within 7 days prior to baseline
• • Receipt of any marketed biological therapy (i.e. immunoglobulin, anti immunoglobulin E) including dupilumab or investigational biologic agents 3 to 6 months prior to baseline