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New shot offers hope for stubborn hand eczema

NCT ID NCT05958407

Disease control Sponsor: LEO Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times

Summary

This study tested a drug called tralokinumab for people with moderate-to-severe atopic hand eczema that hasn't improved with standard treatments. 235 adults received either the drug or a placebo every two weeks for 16 weeks, then everyone got the drug for another 16 weeks. The goal was to see if the drug could clear or nearly clear the eczema and reduce symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

235 people

The number who actually took part.

Started

Aug 2023

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis Atopic hand eczema

Contacts and locations

Locations

  • LEO Investigational Site

    Bretzenheim, 55128, Germany

  • LEO Pharma Investigational Site

    Birmingham, Alabama, 35209, United States

  • LEO Pharma Investigational Site

    Fort Smith, Arkansas, 72916, United States

  • LEO Pharma Investigational Site

    Fountain Valley, California, 92708, United States

  • LEO Pharma Investigational Site

    Los Angeles, California, 90025, United States

  • LEO Pharma Investigational Site

    Sacramento, California, 95816, United States

  • LEO Pharma Investigational Site

    Farmington, Connecticut, 06032, United States

  • LEO Pharma Investigational Site

    Hialeah, Florida, 33012, United States

  • LEO Pharma Investigational Site

    Plainfield, Indiana, 46168, United States

  • LEO Pharma Investigational Site

    Louisville, Kentucky, 40217, United States

  • LEO Pharma Investigational Site

    New Orleans, Louisiana, 70115, United States

  • LEO Pharma Investigational Site

    Bangor, Maine, 04401, United States

  • LEO Pharma Investigational Site

    Caledonia, Michigan, 49316, United States

  • LEO Pharma Investigational Site

    Detroit, Michigan, 48202, United States

  • LEO Pharma Investigational Site

    Portsmouth, New Hampshire, 03801, United States

  • LEO Pharma Investigational Site

    Cortland, New York, 13045, United States

  • LEO Pharma Investigational Site

    New York, New York, 10075, United States

  • LEO Pharma Investigational Site

    Portland, Oregon, 97201, United States

  • LEO Pharma Investigational Site

    Portland, Oregon, 97210, United States

  • LEO Pharma Investigational Site

    Nashville, Tennessee, 37211, United States

  • LEO Pharma Investigational Site

    Dallas, Texas, 75225, United States

  • LEO Pharma Investigational Site

    Frisco, Texas, 75034, United States

  • LEO Pharma Investigational Site

    San Antonio, Texas, 78213, United States

  • LEO Pharma Investigational Site

    Webster, Texas, 77598, United States

  • LEO Pharma Investigational Site

    Brussels, 1200, Belgium

  • LEO Pharma Investigational Site

    Edegem, 2650, Belgium

  • LEO Pharma Investigational Site

    Calgary, Alberta, T3E 0B2, Canada

  • LEO Pharma Investigational Site

    Edmonton, Alberta, T5J 3S9, Canada

  • LEO Pharma Investigational Site

    Edmonton, Alberta, T6X 0N9, Canada

  • LEO Pharma Investigational Site

    Red Deer, Alberta, T4P 1K4, Canada

  • LEO Pharma Investigational Site

    Surrey, British Columbia, V3R 6A7, Canada

  • LEO Pharma Investigational Site

    Fredericton, New Brunswick, E3B 1G9, Canada

  • LEO Pharma Investigational Site

    Hamilton, Ontario, L8L 3C3, Canada

  • LEO Pharma Investigational Site

    Richmond Hill, Ontario, L4B 1A5, Canada

  • LEO Pharma Investigational Site

    Toronto, Ontario, M2N 3A6, Canada

  • LEO Pharma Investigational Site

    Windsor, Ontario, N8T 1E6, Canada

  • LEO Pharma Investigational Site

    Saint-Jérôme, Quebec, J7Z 7E2, Canada

  • LEO Pharma Investigational Site

    Québec, G1V 4X7, Canada

  • LEO Pharma Investigational Site

    Québec, G1W 4R4, Canada

  • LEO Pharma Investigational Site

    Nantes, 44093, France

  • LEO Pharma Investigational Site

    Pierre-Bénite, 69495, France

  • LEO Pharma Investigational Site

    Rouen, 76031, France

  • LEO Pharma Investigational Site

    Frankfurt am Main, 60590, Germany

  • LEO Pharma Investigational Site

    Haßfurt, 97437, Germany

  • LEO Pharma Investigational Site

    Osnabrück, 49074, Germany

  • LEO Pharma Investigational Site

    Tübingen, 72076, Germany

  • LEO Pharma Investigational Site

    Wuppertal, 42283, Germany

  • LEO Pharma Investigational Site

    Amsterdam, 1105 AZ, Netherlands

  • LEO Pharma Investigational Site

    Groningen, 9713 GZ, Netherlands

  • LEO Pharma Investigational Site

    Gdansk, 80-462, Poland

  • LEO Pharma Investigational Site

    Krakow, 30-033, Poland

  • LEO Pharma Investigational Site

    Krakow, 31-011, Poland

  • LEO Pharma Investigational Site

    Wŏnju, Gangwon-do, 26426, South Korea

  • LEO Pharma Investigational Site

    Ansan-si, Gyeonggi-do, 15355, South Korea

  • LEO Pharma Investigational Site

    Yangsan, Gyeongsangnam-do, 05278, South Korea

  • LEO Pharma Investigational Site

    Daegu, 41944, South Korea

  • LEO Pharma Investigational Site

    Seoul, 03080, South Korea

  • LEO Pharma Investigational Site

    Seoul, 04763, South Korea

  • LEO Pharma Investigational Site

    Seoul, 05030, South Korea

  • LEO Pharma Investigational Site

    Seoul, 05278, South Korea

  • LEO Pharma Investigational Site

    Seoul, 4564, South Korea

  • LEO Pharma Investigational Site

    Badalona, Barcelona, 08916, Spain

  • LEO Pharma Investigational Site

    Salford, Greater Manchester, M6 8HD, United Kingdom

  • LEO Pharma Investigational Site

    Middlesbrough, North Yorkshire, TS4 3BW, United Kingdom

  • LEO Pharma Investigational Site

    London, SE1 7EH, United Kingdom

  • LEO Pharma Investigational site

    Ghent, 9000, Belgium

  • LEO Pharma Investigational site

    Alicante, 03010, Spain

  • LEO Pharma Investigational site

    Barcelona, 08916, Spain

  • LEO Pharma Investigational site

    Granada, 18016, Spain

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Other studies related to the condition(s) this trial covers.