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New drug shows promise for stubborn hand and foot eczema in phase 3 trial

NCT ID NCT06921759

Disease control Sponsor: Eli Lilly and Company 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 21, 2026 · Updated 2 times

Summary

This study tests a drug called lebrikizumab against a placebo in 221 adults and teenagers with moderate-to-severe hand and foot eczema. The treatment is given as an injection under the skin over 16 weeks. The main goal is to see if the drug can clear or nearly clear the skin rash and reduce itch better than a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lebrikizumab (a drug given as an injection under the skin)
What this could lead to
If it works, this could provide a new treatment option for people with stubborn hand and foot eczema that hasn't responded to other therapies.
What could go wrong
This is a Phase 3 trial, but results are not yet known. The drug may not work better than placebo, and side effects like injection reactions or infections are possible.

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

221 people

The number who actually took part.

Started

Apr 2025

Finished

Jul 2026

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

12 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: * Have an unequivocal diagnosis of chronic atopic hand and/or foot dermatitis at least 1 year prior to screening, regardless of the extent and severity of concomitant atopic dermatitis (AD) on other areas of the body. AD must be present in at least 2 of the 4 mentioned anatomical areas: left hand, right hand, left foot, or right foot at screening and baseline. * Have a Hand Foot - Investigator Global Assessment (HF-IGA) score of 3 or 4 at the screening and baseline visits. * Have a baseline hand and foot peak pruritus (numeric rating scale) NRS score ≥4. * Have a documented history by the investigator of inadequate response to topical medication(s) (topical corticosteroids (TCIs/TCS), topical PDE-4 inhibitors, or topical janus kinase (JAK) inhibitors) in the treatment of atopic hand foot dermatitis (AHFD) within 6 months of screening, or use of topical medications is medically inadvisable (due to intolerance to treatment, hypersensitivity reactions, significant skin atrophy of hand and feet, and systemic effects, as assessed by the investigator or by the treating physician of the participant). * For adolescent participants, body weight ≥40 kilograms (kg) at baseline. Exclusion Criteria: * Have a positive patch test reaction to 1 or more allergens (a score of 1+ or above according to the International Contact Dermatitis Research Group grading scale) before baseline AND which are deemed to be clinically relevant in the view of the investigator as the current cause of the hand and foot dermatitis. * Have a documented diagnosis of allergic contact dermatitis (ACD) of hands and/or feet, and have a positive patch test reaction at screening, regardless of whether the history of current skin exposure to products containing this allergen (current relevance) is present. * Have a documented or strong clinical suspicion of the diagnosis of protein contact dermatitis of hands and/or feet. These are the participants with occupational or nonoccupational contact with proteins such as food, latex, and so on, who have positive prick test results and present with lesions of contact urticaria or dermatitis on hands and feet. * Have a documented exposure to irritants in the occupational or non-occupational (household/recreational) setting that is believed to be a predominant cause of the current hand and foot dermatitis as per the judgment of the investigator. * Presence of skin comorbidities on hand and/or foot that may interfere with study assessments, such as (but not limited to) palmoplantar psoriasis, palmoplantar keratoderma, impetiginized eczema, lichen planus, pityriasis rubra pilaris, herpes simplex, erythema multiforme, tinea, or scabies. * Have skin comorbidities that may interfere with study assessments. * Treatment with topical medications on the hands and feet within 2 weeks before the baseline visit (except for the use of the participant's own emollients). * Prior treatment with interleukin-13 (IL-13) inhibitors such as lebrikizumab or tralokinumab. * Have received any live attenuated vaccine within less than 4 weeks of the baseline visit or intend to receive a live attenuated vaccine during the study, or within 4 weeks after receiving the last dose of study intervention.

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Conditions

The condition(s) this trial relates to.

atopic eczema dyshidrosis

As listed by the trial registrant

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

Atopic hand and foot dermatitis

Contacts and locations

Locations

  • Ajou University Hospital

    Suwon, 16499, South Korea

  • Arké SMO S.A de C.V

    Veracruz, 91900, Mexico

  • Asan Medical Center

    Seoul, 05505, South Korea

  • CIPREC

    Buenos Aires, C1061AAS, Argentina

  • CONEXA Investigacion Clinica S.A.

    Buenos Aires, 1012, Argentina

  • CaRe Clinic

    Red Deer, T4P 1K4, Canada

  • Care Access - Hoboken

    Hoboken, New Jersey, 07030, United States

  • Centre de Recherche Saint-Louis

    Montreal, H1Y 3L1, Canada

  • Centre de Recherche Saint-Louis

    Québec, G1W 4R4, Canada

  • Centro de Investigaciones San Miguel

    San Miguel, 1663, Argentina

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333, Taiwan

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung Niao Sung Dist, 83301, Taiwan

  • Chosun University Hospital

    Gwangju, 61453, South Korea

  • Complete Dermatology

    Sugar Land, Texas, 77479, United States

  • Cornerstone Dermatology

    Coorparoo, 4151, Australia

  • Cryptex Investigación Clínica S.A. de C.V.

    Cuauhtémoc, Ciudad de México, 06100, Mexico

  • DeNova Research

    Chicago, Illinois, 60602, United States

  • DermEffects

    London, N6H 5L5, Canada

  • Dermatology Research Associates

    Los Angeles, California, 90045, United States

  • Dermatology and Ophthalmology Kume Clinic

    Sakai, 593-8324, Japan

  • Encore Medical Research

    Hollywood, Florida, 33024, United States

  • Eukarya Pharmasite S.C.

    Monterrey, 64718, Mexico

  • FACET Dermatology

    Toronto, M4E 1R7, Canada

  • First OC Dermatology Research Inc

    Fountain Valley, California, 92708, United States

  • Fremantle Dermatology

    Fremantle, 6160, Australia

  • Fundacion Estudios Clinicos

    Rosario, 2000, Argentina

  • Fundación Respirar

    Buenos Aires, C1426ABP, Argentina

  • INECO Neurociencias Oroño

    Rosario, 2000, Argentina

  • INTERMED Groupe Sante

    Chicoutimi, G7H 7Y8, Canada

  • Institute for Skin, Health and Immunity

    Mitcham, 3132, Australia

  • Instituto de Investigaciones Clinicas Rosario

    Rosario, S2000CVD, Argentina

  • Instituto de Neumonologia Y Dermatologia

    Buenos Aires, C1425BEA, Argentina

  • Interior Dermatology Centre - Probity - PPDS

    Kelowna, V1W 4V5, Canada

  • Investigaciones Medicas Imoba Srl

    Buenos Aires, C1056ABH, Argentina

  • Kohler & Milstein Research S.A. De C.V.

    Mérida, 97070, Mexico

  • Konkuk University Medical Center

    Seoul, 05030, South Korea

  • Korea University Ansan Hospital

    Ansan-si, 15355, South Korea

  • Kosugi Dermatology Clinic

    Kawasaki-shi, 211-0063, Japan

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278, South Korea

  • Kyungpook National University Hospital

    Junggu, 41944, South Korea

  • Maruyama Dermatology Clinic

    Kōtoku, 136-0074, Japan

  • MediSearch Clinical Trials

    Saint Joseph, Missouri, 64506, United States

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • National Taiwan University Hospital - Hsinchu branch

    Zhubei, 302, Taiwan

  • New Taipei Municipal TuCheng Hospital

    New Taipei City, 236, Taiwan

  • Optima Research - Boardman

    Boardman, Ohio, 44512, United States

  • Pansy Skin Clinic

    Saitama, 330-0064, Japan

  • Paratus Clinical Research Woden

    Phillip, 2606, Australia

  • Parra Dermatología

    Mendoza, 5500, Argentina

  • Private Practice - Dr. Rachel Asiniwasis

    Regina, S4V 1R9, Canada

  • Progressive Clinical Research

    San Antonio, Texas, 78213, United States

  • Psoriahue

    Buenos Aires, C1425DKG, Argentina

  • Pusan National University Yangsan Hospital

    Busan, 50612, South Korea

  • Renstar Medical Research

    Ocala, Florida, 34470, United States

  • Research Associates of South Florida - Miami - Southwest 8th Street

    Miami, Florida, 33134, United States

  • Revival Research Institute, LLC

    Troy, Michigan, 48084, United States

  • Scientia Investigacion Clinica S.C.

    Chihuahua City, 31203, Mexico

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • SimcoDerm Medical and Surgical Dermatology Center

    Barrie, L4M 7G1, Canada

  • Skin Health Institute Inc.

    Carlton, 3053, Australia

  • Southern Indiana Clinical Trials

    New Albany, Indiana, 47150, United States

  • St George Dermatology & Skin Cancer Centre

    Kogarah, 2217, Australia

  • Tachikawa Dermatology Clinic

    Tachikawa, 190-0023, Japan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tanpopo Skin Clinic

    Ōta-ku, 143-0023, Japan

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218, United States

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital

    Seoul, 06591, South Korea

  • The Catholic University of Korea, Incheon St. Mary's Hospital

    Bupyeong-gu, 21431, South Korea

  • The Skin Centre

    Benowa, 4217, Australia

  • Tokyo Medical University Hospital

    Shinjuku-ku, 160-0023, Japan

  • Tri-Service General Hospital

    Taipei, 114, Taiwan

  • University Hospital,Kyoto Prefectural University of Medicine

    Kyoto, 602-8566, Japan

  • Veracity Clinical Research

    Woolloongabba, 4102, Australia

  • Wiseman Dermatology Research Inc.

    Winnipeg, R3M 3Z4, Canada