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Completed

NCT Number: NCT05958407

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

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.

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Key information

Conditions

Atopic Dermatitis Atopic Hand Eczema Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

LEO Pharma Investigational Site, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tralokinumab

Drug

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

Placebo

Drug

After a loading dose under the skin (s.c.) at baseline, trial participants are administered a placebo dose every two weeks for 16 weeks

Primary outcomes

  1. Percentage of Participants With IGA-AHE Score of 0 (Clear) or 1 (Almost Clear)

    Time frame: At Week 16

    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).

Secondary outcomes

  1. Percentage of Participants Having a ≥2-point Reduction in IGA-AHE Score

    Time frame: From baseline to Week 16

    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).

  2. Percentage of Participants Having a Decrease in HECSI of at Least 75% (HECSI-75)

    Time frame: From baseline (Day 1) to Week 16

    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.

  3. Percentage of Participants Having a Decrease in HECSI of at Least 50% (HECSI-50)

    Time frame: From baseline to Week 16

    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.

  4. Percentage of Participants Having a Decrease in HECSI of at Least 90% (HECSI-90)

    Time frame: From baseline to Week 16

    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.

  5. Percentage Change in HECSI Score

    Time frame: From baseline to Week 16

    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.

  6. Percentage of Participants With Reduction in HESD Itch Score (Weekly Average) of ≥4 Points

    Time frame: From baseline to Week 16

    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.

  7. Percentage Change in HESD Itch Score (Weekly Average)

    Time frame: From baseline to Week 16

    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.

  8. Percentage of Participants With Reduction in HESD Pain Score (Weekly Average) of ≥4 Points

    Time frame: From baseline to Week 16

    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.

  9. Percentage Change in HESD Pain Score (Weekly Average)

    Time frame: From baseline to Week 16

    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.

  10. Percentage Change in HEIS Score

    Time frame: From baseline to Week 16

    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.

  11. Percentage Change in DLQI Score

    Time frame: From baseline to Week 16

    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.

  12. Change in WPAI+CIQ:AHE Domain Scores

    Time frame: From baseline to Week 16

    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.

  13. Number of Participants With IGA-AHE Score of 0 (Clear) or 1 (Almost Clear)

    Time frame: At Week 32

    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).

  14. Number of Participants Having a Decrease in HECSI of at Least 75% (HECSI-75)

    Time frame: From baseline to Week 32

    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.

  15. Number of Participants With Reduction in HESD Itch Score (Weekly Average) of ≥4 Points

    Time frame: From baseline to Week 32

    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.

  16. Number of Participants With Reduction in HESD Pain Score (Weekly Average) of ≥4 Points

    Time frame: From baseline to Week 32

    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.

  17. Percentage Change in HEIS Score

    Time frame: From baseline to Week 32

    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.

  18. Percentage Change in DLQI Score

    Time frame: From baseline to Week 32

    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.

  19. Change in WPAI+CIQ:AHE Domain Scores

    Time frame: From baseline to Week 32

    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.

  20. Number of Treatment-emergent Adverse Events

    Time frame: From baseline to Week 16

    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.

  21. Number of Treatment-emergent Adverse Events During the Open-label Treatment Period

    Time frame: Week 16 to Week 32

    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.

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study 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

Acronym: ADHAND

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2023
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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