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Evaluating Tralokinumab for Moderate-to-Severe Atopic Hand Eczema

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

Phase 3 Interventional LEO Pharma · NCT05958407

This study is testing if a new medication called tralokinumab can help adults with moderate-to-severe atopic hand eczema feel better and improve their quality of life.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment402 (estimated)
Ages18 Years and up
SexAll
SponsorLEO Pharma Industry-sponsored
Drugs / interventionsdupilumab, tralokinumab
Locations76 sites (Birmingham, Alabama and 75 other locations)
Trial IDNCT05958407 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of tralokinumab in treating moderate-to-severe atopic hand eczema in adults. Participants will undergo a screening period followed by a 32-week treatment phase where they will receive either tralokinumab or a placebo. The study will involve multiple assessments to evaluate the severity of eczema, symptoms, and overall quality of life. After the treatment phase, there will be a follow-up period to monitor safety.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of atopic dermatitis and a history of atopic hand eczema that has not responded adequately to topical treatments.

Not a fit: Patients with active infections or those who have not had a recent inadequate response to topical treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from moderate-to-severe atopic hand eczema.

How similar studies have performed: Other studies have shown promise with similar biologic treatments for atopic dermatitis, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 75 other locations

+26 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atopic DermatitisAtopic Hand Eczema
Last reviewed 2026-06-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.