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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Keep this study
Lead
LEO Pharma
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
Clareo Health | 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
