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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06921759




Registration number
NCT06921759
Ethics application status
Date submitted
4/04/2025
Date registered
10/04/2025

Titles & IDs
Public title
A Study to Investigate the Efficacy and Safety of Lebrikizumab in Participants With Moderate-to-Severe Atopic Hand and Foot Dermatitis
Scientific 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
Secondary ID [1] 0 0
J2T-MC-KGCD
Secondary ID [2] 0 0
27349
Universal Trial Number (UTN)
Trial acronym
ADtouch
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Hand and Foot Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lebrikizumab
Treatment: Drugs - Placebo

Experimental: Lebrikizumab - Lebrikizumab administered subcutaneously (SC).

Placebo comparator: Placebo - Placebo Administered SC.


Treatment: Drugs: Lebrikizumab
Administered SC

Treatment: Drugs: Placebo
Administered SC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving a Hand and Foot Investigator Global Assessment (HF-IGA) Score of 0 or 1 with =2-point Improvement from Baseline
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of Participants Who Are "Satisfied" or "Very Satisfied" on Atopic Hand Dermatitis Clearance Satisfaction (AHDCS)
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Percent Change from Baseline in Hand and Foot Peak Pain NRS
Timepoint [3] 0 0
Baseline, Week 16
Secondary outcome [4] 0 0
Percentage of Participants with HF-Peak Pruritus NRS of =4 points at Baseline Who Achieve a =4-point Reduction (Improvement) from Baseline
Timepoint [4] 0 0
Baseline, Week 4
Secondary outcome [5] 0 0
Percent Change from Baseline in Modified Total Lesion Symptom Scale (mTLSS) for Hand and Foot Lesions
Timepoint [5] 0 0
Baseline, Week 16
Secondary outcome [6] 0 0
Percent Change from Baseline in Hand Eczema Severity Index (HECSI) Score for Participants with Hand Dermatitis
Timepoint [6] 0 0
Baseline, Week 16
Secondary outcome [7] 0 0
Percentage of Participants with Hand Dermatitis Achieving HECSI-50 Score
Timepoint [7] 0 0
Week 16
Secondary outcome [8] 0 0
Percentage of Participants with Hand Dermatitis Achieving HECSI-75 Score
Timepoint [8] 0 0
Week 16
Secondary outcome [9] 0 0
Percentage of Participants with Hand Dermatitis Achieving HECSI-90 Score
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
Change from Baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) for Participants with Hand Dermatitis
Timepoint [10] 0 0
Baseline, Week 16

Eligibility
Key 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 corticosteroids (TCS) in the treatment of atopic hand foot dermatitis (AHFD) within 6 months of screening, or use of TCS 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.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
206
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Paratus Clinical Research Woden - Phillip
Recruitment hospital [2] 0 0
Emeritus Research - Botany
Recruitment hospital [3] 0 0
St George Dermatology & Skin Cancer Centre - Kogarah
Recruitment hospital [4] 0 0
The Skin Centre - Benowa
Recruitment hospital [5] 0 0
Cornerstone Dermatology - Coorparoo
Recruitment hospital [6] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment hospital [7] 0 0
Emeritus Research - Camberwell
Recruitment hospital [8] 0 0
Skin Health Institute Inc. - Carlton
Recruitment hospital [9] 0 0
Institute for Skin, Health and Immunity - Mitcham
Recruitment hospital [10] 0 0
Fremantle Dermatology - Fremantle
Recruitment hospital [11] 0 0
Brecken Health Bunbury - South Bunbury
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2019 - Botany
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
4217 - Benowa
Recruitment postcode(s) [5] 0 0
4151 - Coorparoo
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
3124 - Camberwell
Recruitment postcode(s) [8] 0 0
3053 - Carlton
Recruitment postcode(s) [9] 0 0
3132 - Mitcham
Recruitment postcode(s) [10] 0 0
6160 - Fremantle
Recruitment postcode(s) [11] 0 0
6230 - South Bunbury
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Argentina
State/province [11] 0 0
Buenos Aires
Country [12] 0 0
Argentina
State/province [12] 0 0
Ciudad Autónoma De Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
Santa Fe
Country [14] 0 0
Argentina
State/province [14] 0 0
Mendoza
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
British Columbia
Country [17] 0 0
Canada
State/province [17] 0 0
Manitoba
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Canada
State/province [20] 0 0
Saskatchewan
Country [21] 0 0
Japan
State/province [21] 0 0
Kanagawa
Country [22] 0 0
Japan
State/province [22] 0 0
Osaka
Country [23] 0 0
Japan
State/province [23] 0 0
Tokyo
Country [24] 0 0
Japan
State/province [24] 0 0
Kyoto
Country [25] 0 0
Japan
State/province [25] 0 0
Saitama
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Incheon-gwangyeoksi [Incheon]
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Kyonggi-do
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Kyongsangnam-do
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Seoul-teukbyeolsi [Seoul]
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Taegu-Kwangyokshi
Country [31] 0 0
Mexico
State/province [31] 0 0
Distrito Federal
Country [32] 0 0
Mexico
State/province [32] 0 0
Jalisco
Country [33] 0 0
Mexico
State/province [33] 0 0
Nuevo León
Country [34] 0 0
Mexico
State/province [34] 0 0
Yucatán
Country [35] 0 0
Mexico
State/province [35] 0 0
Chihuahua
Country [36] 0 0
Mexico
State/province [36] 0 0
Veracruz
Country [37] 0 0
Taiwan
State/province [37] 0 0
Hsinchu
Country [38] 0 0
Taiwan
State/province [38] 0 0
Kaohsiung
Country [39] 0 0
Taiwan
State/province [39] 0 0
New Taipei
Country [40] 0 0
Taiwan
State/province [40] 0 0
Taipei
Country [41] 0 0
Taiwan
State/province [41] 0 0
Tainan
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
3176154559
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06921759