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Atopic Hand and Foot DermatitisPhase 3ADtouchNCT06921759

A Study to Investigate the Efficacy and Safety of Lebrikizumab in Participants With Moderate-to-Severe Atopic Hand and Foot Dermatitis

A Phase 3 study testing Lebrikizumab in people with Atopic Hand and Foot Dermatitis, run by Eli Lilly and Company at 76 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main purpose of this study is to assess the efficacy of lebrikizumab versus placebo on skin lesions in adults and adolescent participants with atopic hand and foot dermatitis. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Atopic Hand and Foot Dermatitis
What is being tested?
Lebrikizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
221 participants
Where
76 sitesin 8 countries
Study dates
21 Apr 2025to 28 Jul 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

76 sites in 8 countries.

76 sites in 8 countries

United States14 sites

  • Optima Research - Boardman

    Boardman, Ohio, 44512

  • DeNova Research

    Chicago, Illinois, 60602

  • First OC Dermatology Research Inc

    Fountain Valley, California, 92708

  • Care Access - Hoboken

    Hoboken, New Jersey, 07030

  • Encore Medical Research

    Hollywood, Florida, 33024

  • Dermatology Research Associates

    Los Angeles, California, 90045

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

    Miami, Florida, 33134

  • Southern Indiana Clinical Trials

    New Albany, Indiana, 47150

  • Renstar Medical Research

    Ocala, Florida, 34470

  • MediSearch Clinical Trials

    Saint Joseph, Missouri, 64506

  • Progressive Clinical Research

    San Antonio, Texas, 78213

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

  • Complete Dermatology

    Sugar Land, Texas, 77479

  • Revival Research Institute, LLC

    Troy, Michigan, 48084

Other trials in United States

South Korea12 sites

  • Korea University Ansan Hospital

    Ansan-si, 15355

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

    Bupyeong-gu, 21431

  • Pusan National University Yangsan Hospital

    Busan, 50612

  • Chosun University Hospital

    Gwangju, 61453

  • Kyungpook National University Hospital

    Junggu, 41944

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Konkuk University Medical Center

    Seoul, 05030

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278

  • Asan Medical Center

    Seoul, 05505

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

    Seoul, 06591

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

Argentina11 sites

  • CONEXA Investigacion Clinica S.A.

    Buenos Aires, 1012

  • Investigaciones Medicas Imoba Srl

    Buenos Aires, C1056ABH

  • CIPREC

    Buenos Aires, C1061AAS

  • Instituto de Neumonologia Y Dermatologia

    Buenos Aires, C1425BEA

  • Psoriahue

    Buenos Aires, C1425DKG

  • Fundación Respirar

    Buenos Aires, C1426ABP

  • Parra Dermatología

    Mendoza, 5500

  • Fundacion Estudios Clinicos

    Rosario, 2000

  • INECO Neurociencias Oroño

    Rosario, 2000

  • Instituto de Investigaciones Clinicas Rosario

    Rosario, S2000CVD

  • Centro de Investigaciones San Miguel

    San Miguel, 1663

Other trials in Argentina

Canada10 sites

  • SimcoDerm Medical and Surgical Dermatology Center

    Barrie, L4M 7G1

  • INTERMED Groupe Sante

    Chicoutimi, G7H 7Y8

  • Interior Dermatology Centre - Probity - PPDS

    Kelowna, V1W 4V5

  • DermEffects

    London, N6H 5L5

  • Centre de Recherche Saint-Louis

    Montreal, H1Y 3L1

  • Centre de Recherche Saint-Louis

    Québec, G1W 4R4

  • CaRe Clinic

    Red Deer, T4P 1K4

  • Private Practice - Dr. Rachel Asiniwasis

    Regina, S4V 1R9

  • FACET Dermatology

    Toronto, M4E 1R7

  • Wiseman Dermatology Research Inc.

    Winnipeg, R3M 3Z4

Other trials in Canada

Australia8 sites

  • The Skin Centre

    Benowa, 4217

  • Skin Health Institute Inc.

    Carlton, 3053

  • Cornerstone Dermatology

    Coorparoo, 4151

  • Fremantle Dermatology

    Fremantle, 6160

  • St George Dermatology & Skin Cancer Centre

    Kogarah, 2217

  • Institute for Skin, Health and Immunity

    Mitcham, 3132

  • Paratus Clinical Research Woden

    Phillip, 2606

  • Veracity Clinical Research

    Woolloongabba, 4102

Other trials in Australia

Japan8 sites

  • Kosugi Dermatology Clinic

    Kawasaki-shi, 211-0063

  • Maruyama Dermatology Clinic

    Kōtoku, 136-0074

  • University Hospital,Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Tanpopo Skin Clinic

    Ōta-ku, 143-0023

  • Pansy Skin Clinic

    Saitama, 330-0064

  • Dermatology and Ophthalmology Kume Clinic

    Sakai, 593-8324

  • Tokyo Medical University Hospital

    Shinjuku-ku, 160-0023

  • Tachikawa Dermatology Clinic

    Tachikawa, 190-0023

Other trials in Japan

Taiwan8 sites

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung Niao Sung Dist, 83301

  • New Taipei Municipal TuCheng Hospital

    New Taipei City, 236

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Tri-Service General Hospital

    Taipei, 114

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

  • National Taiwan University Hospital - Hsinchu branch

    Zhubei, 302

Other trials in Taiwan

Mexico5 sites

  • Scientia Investigacion Clinica S.C.

    Chihuahua City, 31203

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

    Cuauhtémoc, Ciudad de México, 06100

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

    Mérida, 97070

  • Eukarya Pharmasite S.C.

    Monterrey, 64718

  • Arké SMO S.A de C.V

    Veracruz, 91900

Other trials in Mexico

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Atopic Hand and Foot Dermatitis

The main purpose of this study is to assess the efficacy of lebrikizumab versus placebo on skin lesions in adults and adolescent participants with atopic hand and foot dermatitis.

This study lasts up to 32 weeks, including a 6-week screening period, a 16-week treatment period, and a safety follow-up visit 12 weeks after the last dose.

Being tested
Lebrikizumab, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LebrikizumabDrug

    Also called LY3650150

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT06921759
Study groupRoleWhat they receive
LebrikizumabExperimentalLebrikizumab administered subcutaneously (SC).
Receives: Drug: Lebrikizumab
PlaceboPlacebo comparatorPlacebo Administered SC.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving a Hand and Foot Investigator Global Assessment (HF-IGA) Score of 0 or 1 with ≥2-point Improvement from Baseline

    The HF-IGA is an assessment scale used to determine the severity of hand and foot atopic dermatitis (AD) and clinical response to treatment on a 5-point scale, 0 (clear) to 4 (severe). Higher scores indicate more disease severity.

    Measured: Week 16

Secondary outcomes (14)

  1. Percentage of Participants with a HF-Peak Pruritus Numeric Rating Score (NRS) of ≥4 points at Baseline Who Achieve a ≥4-point Reduction (Improvement) from Baseline

    The HF-peak pruritus NRS scale is an assessment tool used daily by the participants to rate their worst hand and feet itch intensity on a scale ranging from 0 (no itch) to 10 (worst imaginable itch).

    Measured: Week 16

  2. Percentage of Participants with a HF-Peak Pruritus Numeric Rating Score (NRS) of ≥4 points at Baseline Who Achieve a ≥4-point Reduction (Improvement) from Baseline

    The HF-peak pruritus NRS scale is an assessment tool used daily by the participants to rate their worst hand and feet itch intensity on a scale ranging from 0 (no itch) to 10 (worst imaginable itch).

    Measured: Week 2

  3. Percentage of Participants with HF-Peak Pruritus NRS of ≥4 points at Baseline Who Achieve a ≥4-point Reduction (Improvement) from Baseline

    The HF-peak pruritus NRS scale is an assessment tool used daily by the participants to rate their worst hand and feet itch intensity on a scale ranging from 0 (no itch) to 10 (worst imaginable itch).

    Measured: Baseline, Week 4

  4. Percentage of Participants with a HF-Peak Pain NRS of ≥4 points at Baseline Who Achieve a ≥4-point Reduction (Improvement) from Baseline

    The HF-peak pain NRS Scale is an assessment tool used daily by the participants to report the intensity of pain. Participants select the number between 0 and 10 that best fits their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain possible).

    Measured: Week 16

  5. Percentage of Participants Achieving a Hand and Foot Investigator Global Assessment (HF-IGA) Score of 0 or 1 with ≥2-point Improvement from Baseline

    The HF-IGA is an assessment scale used to determine the severity of hand and foot atopic dermatitis (AD) and clinical response to treatment on a 5-point scale, 0 (clear) to 4 (severe). Higher scores indicate more disease severity.

    Measured: Week 4

  6. Percentage of Participants Achieving a Hand and Foot Investigator Global Assessment (HF-IGA) Score of 0 or 1 with ≥2-point Improvement from Baseline

    The HF-IGA is an assessment scale used to determine the severity of hand and foot atopic dermatitis (AD) and clinical response to treatment on a 5-point scale, 0 (clear) to 4 (severe). Higher scores indicate more disease severity.

    Measured: Week 8

  7. Percentage of Participants Who Are "Satisfied" or "Very Satisfied" on Atopic Hand Dermatitis Clearance Satisfaction (AHDCS)

    This single-item question assesses participants' satisfaction with hand clearance at the current time. The response options are reported as the percentage of participants who selected 1 of the following: Very Satisfied, Satisfied, Neither Satisfied nor Dissatisfied, Dissatisfied, or Very Dissatisfied.

    Measured: Week 16

  8. Percent Change from Baseline in Hand and Foot Peak Pain NRS

    The HF-peak pain NRS Scale is an assessment tool used daily by the participants to report the intensity of pain. Participants select the number between 0 and 10 that best fits their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain possible).

    Measured: Baseline, Week 16

  9. Percent Change from Baseline in Modified Total Lesion Symptom Scale (mTLSS) for Hand and Foot Lesions

    The mTLSS is an investigator-reported scale that combines the evaluation of lesion severity of hand eczema (HE) (erythema, edema, desquamation, fissures, hyperkeratosis or lichenification, and vesicles) with the intensity of pruritus or pain to assess the severity of symptoms. This composite score assigns 0 (mild) to 3 (severe) to each component, giving a maximum disease severity of 21. A separate score is assigned for hands and feet.

    Measured: Baseline, Week 16

  10. Percentage of Participants with Hand Dermatitis Achieving HECSI-90 Score

    The HECSI scoring system incorporates both the extent and the intensity of the disease. The total sum called the HECSI score will be calculated, varying from 0 to a maximum severity score of 360 points.

    Measured: Week 16

  11. Percent Change from Baseline in Hand Eczema Severity Index (HECSI) Score for Participants with Hand Dermatitis

    The HECSI scoring system incorporates both the extent and the intensity of the disease. The total sum called the HECSI score will be calculated, varying from 0 to a maximum severity score of 360 points.

    Measured: Baseline, Week 16

  12. Percentage of Participants with Hand Dermatitis Achieving HECSI-50 Score

    The HECSI scoring system incorporates both the extent and the intensity of the disease. The total sum called the HECSI score will be calculated, varying from 0 to a maximum severity score of 360 points.

    Measured: Week 16

  13. Percentage of Participants with Hand Dermatitis Achieving HECSI-75 Score

    The HECSI scoring system incorporates both the extent and the intensity of the disease. The total sum called the HECSI score will be calculated, varying from 0 to a maximum severity score of 360 points.

    Measured: Week 16

  14. Change from Baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) for Participants with Hand Dermatitis

    The QOLHEQ consists of 30 items that can be summarized according to 4 domains of HRQoL: impairments over the last 7 days because of (1) symptoms, (2) emotions, (3) limitations in functioning, or (4) treatment and prevention. The total QOLHEQ score ranges between 0 and 117, with higher scores indicative of a poor HE-specific HRQoL.

    Measured: Baseline, Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2025
  2. Study start21 Apr 2025
  3. Primary completion13 May 2026
  4. Study completion28 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06921759
Sponsor's protocol ID
27349
Other IDs
J2T-MC-KGCD
Acronym
ADtouch
Status last verified
Aug 2026
First submitted
4 Apr 2025
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lebrikizumab in people with Atopic Hand and Foot Dermatitis, run by Eli Lilly and Company at 76 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, South Korea, Argentina, Canada, Australia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving a Hand and Foot Investigator Global Assessment (HF-IGA) Score of 0 or 1 with ≥2-point Improvement from Baseline (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06921759.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

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