Atopic DermatitisPhase 3ADHANDNCT05958407
A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy
A Phase 3 study testing Tralokinumab in people with Atopic Dermatitis and Atopic Hand Eczema, run by LEO Pharma at 69 sites in 10 countries.
Trial summary
The purpose of this study is to test if treatment with tralokinumab is safe and efficacious in treating moderate-to-severe atopic hand eczema. This will be judged by a range of assessments that rate the severity and extent of atopic hand eczema and its symptoms, as well as general health status and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis, Atopic Hand Eczema
- What is being tested?
- Tralokinumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 235 participants
- Where
- 69 sitesin 10 countries
- Study dates
- 28 Aug 2023to 22 Sep 2025
- Phase
- Phase 3
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
69 sites in 10 countries.
69 sites in 10 countries
United States23 sites
LEO Pharma Investigational Site
Bangor, Maine, 04401
LEO Pharma Investigational Site
Birmingham, Alabama, 35209
LEO Pharma Investigational Site
Caledonia, Michigan, 49316
LEO Pharma Investigational Site
Cortland, New York, 13045
LEO Pharma Investigational Site
Dallas, Texas, 75225
LEO Pharma Investigational Site
Detroit, Michigan, 48202
LEO Pharma Investigational Site
Farmington, Connecticut, 06032
LEO Pharma Investigational Site
Fort Smith, Arkansas, 72916
LEO Pharma Investigational Site
Fountain Valley, California, 92708
LEO Pharma Investigational Site
Frisco, Texas, 75034
LEO Pharma Investigational Site
Hialeah, Florida, 33012
LEO Pharma Investigational Site
Los Angeles, California, 90025
LEO Pharma Investigational Site
Louisville, Kentucky, 40217
LEO Pharma Investigational Site
Nashville, Tennessee, 37211
LEO Pharma Investigational Site
New Orleans, Louisiana, 70115
LEO Pharma Investigational Site
New York, New York, 10075
LEO Pharma Investigational Site
Plainfield, Indiana, 46168
LEO Pharma Investigational Site
Portland, Oregon, 97201
LEO Pharma Investigational Site
Portland, Oregon, 97210
LEO Pharma Investigational Site
Portsmouth, New Hampshire, 03801
LEO Pharma Investigational Site
Sacramento, California, 95816
LEO Pharma Investigational Site
San Antonio, Texas, 78213
LEO Pharma Investigational Site
Webster, Texas, 77598
Canada13 sites
LEO Pharma Investigational Site
Calgary, Alberta, T3E 0B2
LEO Pharma Investigational Site
Edmonton, Alberta, T5J 3S9
LEO Pharma Investigational Site
Edmonton, Alberta, T6X 0N9
LEO Pharma Investigational Site
Fredericton, New Brunswick, E3B 1G9
LEO Pharma Investigational Site
Hamilton, Ontario, L8L 3C3
LEO Pharma Investigational Site
Québec, G1V 4X7
LEO Pharma Investigational Site
Québec, G1W 4R4
LEO Pharma Investigational Site
Red Deer, Alberta, T4P 1K4
LEO Pharma Investigational Site
Richmond Hill, Ontario, L4B 1A5
LEO Pharma Investigational Site
Saint-Jérôme, Quebec, J7Z 7E2
LEO Pharma Investigational Site
Surrey, British Columbia, V3R 6A7
LEO Pharma Investigational Site
Toronto, Ontario, M2N 3A6
LEO Pharma Investigational Site
Windsor, Ontario, N8T 1E6
South Korea9 sites
LEO Pharma Investigational Site
Ansan-si, Gyeonggi-do, 15355
LEO Pharma Investigational Site
Daegu, 41944
LEO Pharma Investigational Site
Seoul, 03080
LEO Pharma Investigational Site
Seoul, 04763
LEO Pharma Investigational Site
Seoul, 05030
LEO Pharma Investigational Site
Seoul, 05278
LEO Pharma Investigational Site
Seoul, 4564
LEO Pharma Investigational Site
Wŏnju, Gangwon-do, 26426
LEO Pharma Investigational Site
Yangsan, Gyeongsangnam-do, 05278
Germany6 sites
LEO Investigational Site
Bretzenheim, 55128
LEO Pharma Investigational Site
Frankfurt am Main, 60590
LEO Pharma Investigational Site
Haßfurt, 97437
LEO Pharma Investigational Site
Osnabrück, 49074
LEO Pharma Investigational Site
Tübingen, 72076
LEO Pharma Investigational Site
Wuppertal, 42283
Spain4 sites
LEO Pharma Investigational site
Alicante, 03010
LEO Pharma Investigational Site
Badalona, Barcelona, 08916
LEO Pharma Investigational site
Barcelona, 08916
LEO Pharma Investigational site
Granada, 18016
Belgium3 sites
LEO Pharma Investigational Site
Brussels, 1200
LEO Pharma Investigational Site
Edegem, 2650
LEO Pharma Investigational site
Ghent, 9000
France3 sites
LEO Pharma Investigational Site
Nantes, 44093
LEO Pharma Investigational Site
Pierre-Bénite, 69495
LEO Pharma Investigational Site
Rouen, 76031
Poland3 sites
LEO Pharma Investigational Site
Gdansk, 80-462
LEO Pharma Investigational Site
Krakow, 30-033
LEO Pharma Investigational Site
Krakow, 31-011
United Kingdom3 sites
LEO Pharma Investigational Site
London, SE1 7EH
LEO Pharma Investigational Site
Middlesbrough, North Yorkshire, TS4 3BW
LEO Pharma Investigational Site
Salford, Greater Manchester, M6 8HD
Netherlands2 sites
LEO Pharma Investigational Site
Amsterdam, 1105 AZ
LEO Pharma Investigational Site
Groningen, 9713 GZ
About this study
Official title: 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
The purpose of this study is to test if treatment with tralokinumab is safe and efficacious in treating moderate-to-severe atopic hand eczema. This will be judged by a range of assessments that rate the severity and extent of atopic hand eczema and its symptoms, as well as general health status and quality of life.
The trial will last for up to 40 weeks for each participant. There will be up to 15 visits for each participant, 3 of which will be conducted by phone. The first part of the trial is called a screening period and will last up to 4 weeks. For the first 16 weeks after screening, trial participants will receive either tralokinumab or dummy injections every two weeks. After the first 16 weeks, all trial participants will receive tralokinumab injections every two weeks for 16 weeks. The last part of the trial is a period of 4 weeks after the end of treatment period, where trial participants will not receive tralokinumab but are monitored for safety.
- Conditions
- Atopic Dermatitis, Atopic Hand Eczema
- Being tested
- Tralokinumab, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TralokinumabDrug
After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants are administered a dose of 300 mg every two weeks for 32 weeks
PlaceboDrug
After a loading dose under the skin (s.c.) at baseline, trial participants are administered a placebo dose every two weeks for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Tralokinumab | Experimental | Tralokinumab is administered for 32 weeks (16 weeks double-blinded period + 16 weeks open-label period) Receives: Drug: Tralokinumab |
| Placebo + tralokinumab | Placebo comparator | Placebo is administered for 16 weeks (double-blinded period) prior to roll-over to a 16 weeks open-label period where tralokinumab is administered Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With IGA-AHE Score of 0 (Clear) or 1 (Almost Clear)
IGA-AHE: The Investigator's Global Assessment for atopic hand eczema (IGA-AHE) is an instrument to rate the severity of the subject's AHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: At Week 16
Secondary outcomes (21)
Percentage of Participants Having a ≥2-point Reduction in IGA-AHE Score
IGA-AHE: The Investigator's Global Assessment for atopic hand eczema (IGA-AHE) is an instrument to rate the severity of the subject's AHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: From baseline to Week 16
Percentage of Participants Having a Decrease in HECSI of at Least 75% (HECSI-75)
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-75 is defined as at least 75% improvement in HECSI score from baseline.
Measured: From baseline (Day 1) to Week 16
Percentage of Participants Having a Decrease in HECSI of at Least 50% (HECSI-50)
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-50 is defined as at least 50% improvement in HECSI score from baseline.
Measured: From baseline to Week 16
Percentage of Participants Having a Decrease in HECSI of at Least 90% (HECSI-90)
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-90 is defined as at least 90% improvement in HECSI score from baseline.
Measured: From baseline to Week 16
Percentage Change in HECSI Score
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity.
Measured: From baseline to Week 16
Percentage of Participants With Reduction in HESD Itch Score (Weekly Average) of ≥4 Points
The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
Measured: From baseline to Week 16
Percentage Change in HESD Itch Score (Weekly Average)
The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
Measured: From baseline to Week 16
Percentage of Participants With Reduction in HESD Pain Score (Weekly Average) of ≥4 Points
The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'pain' component and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.
Measured: From baseline to Week 16
Percentage Change in HESD Pain Score (Weekly Average)
The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'pain' component and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.
Measured: From baseline to Week 16
Percentage Change in HEIS Score
HEIS: The Hand Eczema Impact Scale (HEIS) includes 9 items addressing the participant's perception of the impact of hand eczema on their daily activities, embarrassment, frustration, sleep, work, and physical functioning over the past 7 days. Each item is scored on a 5-point scale (0='not at all', 1='a little', 2='moderately', 3='a lot', 4='extremely'). The HEIS score is the average of the 9 items.
Measured: From baseline to Week 16
Percentage Change in DLQI Score
The Dermatology Life Quality Index (DLQI) consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life over the last week. The DLQI score is the sum of the 10 items (score ranging from 0 to 30); a high score is indicative of a poor quality of life.
Measured: From baseline to Week 16
Change in WPAI+CIQ:AHE Domain Scores
The impact of AHE on the subject's ability to work/school and perform regular activities was assessed by Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire in atopic hand eczema (WPAI+CIQ:AHE), which is an instrument to measure impairments in both paid work and unpaid work/school attendance. Only domain scores where an estimand analysis was possible are presented. Scores are on a scale from 0 to 100 and reflect the percentage impairment due to AHE during the past 7 days, with higher numbers indicating greater impairment and less productivity/school attendance.
Measured: From baseline to Week 16
Number of Participants With IGA-AHE Score of 0 (Clear) or 1 (Almost Clear)
The Investigator's Global Assessment for atopic hand eczema (IGA-AHE) is an instrument to rate the severity of the subject's AHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: At Week 32
Number of Participants Having a Decrease in HECSI of at Least 75% (HECSI-75)
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score ranges from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-75 is defined as at least 75% improvement in HECSI score from baseline.
Measured: From baseline to Week 32
Number of Participants With Reduction in HESD Itch Score (Weekly Average) of ≥4 Points
The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
Measured: From baseline to Week 32
Number of Participants With Reduction in HESD Pain Score (Weekly Average) of ≥4 Points
The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
Measured: From baseline to Week 32
Percentage Change in HEIS Score
HEIS: The Hand Eczema Impact Scale (HEIS) includes 9 items addressing the participant's perception of the impact of hand eczema on their daily activities, embarrassment, frustration, sleep, work, and physical functioning over the past 7 days. Each item is scored on a 5-point scale (0='not at all', 1='a little', 2='moderately', 3='a lot', 4='extremely'). The HEIS score is the average of the 9 items.
Measured: From baseline to Week 32
Percentage Change in DLQI Score
The Dermatology Life Quality Index (DLQI) consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life over the last week. The DLQI score is the sum of the 10 items (score ranging from 0 to 30); a high score is indicative of a poor quality of life.
Measured: From baseline to Week 32
Change in WPAI+CIQ:AHE Domain Scores
The impact of AHE on the subject's ability to work/school and perform regular activities was assessed by Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire in atopic hand eczema (WPAI+CIQ:AHE), which is an instrument to measure impairments in both paid work and unpaid work/school attendance. Only domain scores where an estimand analysis was possible are presented. Scores are on a scale from 0 to 100 and reflect the percentage impairment due to AHE during the past 7 days, with higher numbers indicating greater impairment and less productivity/school attendance.
Measured: From baseline to Week 32
Number of Treatment-emergent Adverse Events
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
Measured: From baseline to Week 16
Number of Treatment-emergent Adverse Events During the Open-label Treatment Period
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
Measured: Week 16 to Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start28 Aug 2023
- Primary completion5 May 2025
- Study completion22 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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, Investigator
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958407
- Sponsor's protocol ID
- LP0162-2328
- Other IDs
- U1111-1285-7014, 2022-502653-34-00
- Acronym
- ADHAND
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2023
- Last updated
- 22 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Armstrong A, Kircik L, Metelitsa A, Warren RB, Rodriguez A, Volc S, Issa N, Chovatiya R, von Eyben R, Festini T, Johansen P, Ehst B. Tralokinumab Versus Dupilumab for the Treatment of Atopic Dermatitis with Moderate-to-Severe Hand Involvement: A Matching-Adjusted Indirect Comparison. Dermatol Ther (Heidelb). 2026 Oct 2. doi: 10.1007/s13555-026-01922-8. Online ahead of print.
PubMed 42825999