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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 (ADHAND)

Primary Purpose

Atopic Dermatitis, Atopic Hand Eczema

Status
Recruiting
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Tralokinumab
Placebo
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting
  • LEO Pharma Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tralokinumab

Placebo + tralokinumab

Arm Description

Tralokinumab is administered for 32 weeks (16 weeks double-blinded period + 16 weeks open-label period)

Placebo is administered for 16 weeks (double-blinded period) prior to roll-over to a 16 weeks open-label period where tralokinumab is administered

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Having a decrease in HECSI of at least 75% (HECSI-75)
HECSI: The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs using a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and the extent of the lesions on each of the 5 hand areas by assessing the percentage of the areas these lesions occupy and converting it to a score based on a 5-point scale.
Having a decrease in HECSI of at least 50% (HECSI-50)
Having a decrease in HECSI of at least 90% (HECSI-90)
Percentage change in HECSI score
Having a ≥2-point reduction in IGA-AHE score
Reduction in HESD itch score (weekly average) of ≥4 points
HESD: 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)'. Only the items on itch and pain will be completed.
Reduction in HESD pain score (weekly average) of ≥4 points
Among subjects with a baseline HESD pain score (weekly average) ≥4 points.
Percentage change in HEIS score
HEIS: The Hand Eczema Impact Scale (HEIS) includes 9 items addressing the subject's perception of the impact of hand eczema on their daily activities 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').
Percentage change in DLQI score
DLQI: 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. Each item is scored on a 4-point Likert scale (0 = 'not at all ⁄not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much').
Percentage change in HESD itch score (weekly average)
Percentage change in HESD pain score (weekly average)
Change in WPAI+CIQ:AHE domain scores
WPAI+CIQ:AHE: The impact of AHE on the subject's ability to work/school and perform regular activities will be assessed by WPAI+CIQ:AHE, which is an instrument to measure impairments in both paid work and unpaid work/school attendance. The WPAI+CIQ:AHE consists of 10 items, and scores can be calculated for 7 domains, each reflecting the percentage impairment due to AHE during the past 7 days, with higher numbers indicating greater impairment and less productivity/school attendance.
Number of treatment-emergent adverse events
IGA-AHE score of 0 (clear) or 1 (almost clear)
Having a decrease in HECSI of at least 75% (HECSI-75)
Reduction in HESD itch score (weekly average) of ≥4 points
Reduction in HESD pain score (weekly average) of ≥4 points
Among subjects with a baseline HESD pain score (weekly average) ≥4 points
Percentage change in HEIS score
Percentage change in DLQI score
Change in WPAI+CIQ:AHE domain scores
Number of treatment-emergent adverse events during the open-label treatment period

Full Information

First Posted
July 13, 2023
Last Updated
October 19, 2023
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT05958407
Brief Title
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
Acronym
ADHAND
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2023 (Actual)
Primary Completion Date
November 1, 2026 (Anticipated)
Study Completion Date
March 22, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to test if treatment with tralokinumab is safe and effectful to treat 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. There will be up to 15 visits, 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 are off the drug for safety follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Atopic Hand Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
402 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tralokinumab
Arm Type
Experimental
Arm Description
Tralokinumab is administered for 32 weeks (16 weeks double-blinded period + 16 weeks open-label period)
Arm Title
Placebo + tralokinumab
Arm Type
Placebo Comparator
Arm Description
Placebo is administered for 16 weeks (double-blinded period) prior to roll-over to a 16 weeks open-label period where tralokinumab is administered
Intervention Type
Drug
Intervention Name(s)
Tralokinumab
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
IGA-AHE score of 0 (clear) or 1 (almost clear)
Description
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).
Time Frame
At Week 16
Secondary Outcome Measure Information:
Title
Having a decrease in HECSI of at least 75% (HECSI-75)
Description
HECSI: The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs using a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and the extent of the lesions on each of the 5 hand areas by assessing the percentage of the areas these lesions occupy and converting it to a score based on a 5-point scale.
Time Frame
From baseline (Day 1) to Week 16
Title
Having a decrease in HECSI of at least 50% (HECSI-50)
Time Frame
From baseline to Week 16
Title
Having a decrease in HECSI of at least 90% (HECSI-90)
Time Frame
From baseline to Week 16
Title
Percentage change in HECSI score
Time Frame
From baseline to Week 16
Title
Having a ≥2-point reduction in IGA-AHE score
Time Frame
From baseline to Week 16
Title
Reduction in HESD itch score (weekly average) of ≥4 points
Description
HESD: 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)'. Only the items on itch and pain will be completed.
Time Frame
From baseline to Week 16
Title
Reduction in HESD pain score (weekly average) of ≥4 points
Description
Among subjects with a baseline HESD pain score (weekly average) ≥4 points.
Time Frame
From baseline to Week 16
Title
Percentage change in HEIS score
Description
HEIS: The Hand Eczema Impact Scale (HEIS) includes 9 items addressing the subject's perception of the impact of hand eczema on their daily activities 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').
Time Frame
From baseline to Week 16
Title
Percentage change in DLQI score
Description
DLQI: 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. Each item is scored on a 4-point Likert scale (0 = 'not at all ⁄not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much').
Time Frame
From baseline to Week 16
Title
Percentage change in HESD itch score (weekly average)
Time Frame
From baseline to Week 16
Title
Percentage change in HESD pain score (weekly average)
Time Frame
From baseline to Week 16
Title
Change in WPAI+CIQ:AHE domain scores
Description
WPAI+CIQ:AHE: The impact of AHE on the subject's ability to work/school and perform regular activities will be assessed by WPAI+CIQ:AHE, which is an instrument to measure impairments in both paid work and unpaid work/school attendance. The WPAI+CIQ:AHE consists of 10 items, and scores can be calculated for 7 domains, each reflecting the percentage impairment due to AHE during the past 7 days, with higher numbers indicating greater impairment and less productivity/school attendance.
Time Frame
From baseline to Week 16
Title
Number of treatment-emergent adverse events
Time Frame
From baseline to Week 16
Title
IGA-AHE score of 0 (clear) or 1 (almost clear)
Time Frame
At Week 32
Title
Having a decrease in HECSI of at least 75% (HECSI-75)
Time Frame
From baseline to Week 32
Title
Reduction in HESD itch score (weekly average) of ≥4 points
Time Frame
From baseline to Week 32
Title
Reduction in HESD pain score (weekly average) of ≥4 points
Description
Among subjects with a baseline HESD pain score (weekly average) ≥4 points
Time Frame
From baseline to Week 32
Title
Percentage change in HEIS score
Time Frame
From baseline to Week 32
Title
Percentage change in DLQI score
Time Frame
From baseline to Week 32
Title
Change in WPAI+CIQ:AHE domain scores
Time Frame
From baseline to Week 32
Title
Number of treatment-emergent adverse events during the open-label treatment period
Time Frame
Week 16 to Week 32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Disclosure
Phone
(+1) 8775571168
Email
clinicaltrialscontactus@leo-pharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Expert
Organizational Affiliation
LEO Pharma
Official's Role
Study Director
Facility Information:
Facility Name
LEO Pharma Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 0B2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LEO PI Site
Facility Name
LEO Pharma Investigational Site
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4P 1K4
Country
Canada
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 1G9
Country
Canada
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2N 3A6
Country
Canada
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8T 1E6
Country
Canada
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Saint-Jérôme
State/Province
Quebec
ZIP/Postal Code
J7Z 7E2
Country
Canada
Individual Site Status
Recruiting
Facility Name
LEO Pharma Investigational Site
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified IPD can be made available to researchers in a closed environment for a specified period of time
IPD Sharing Access Criteria
Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
IPD Sharing URL
http://leopharmatrials.com/for-professionals

Learn more about this trial

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

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