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)

April 10, 2024 updated by: LEO Pharma

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

402

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • Quebec, Canada, G1W 4R4
        • Recruiting
        • LEO Pharma Investigational Site
      • Quebec, Canada, G1V 4X7
        • Recruiting
        • LEO Pharma Investigational Site
    • Alberta
      • Calgary, Alberta, Canada, T3E 0B2
        • Recruiting
        • LEO Pharma Investigational Site
        • Contact:
          • LEO PI Site
      • Edmonton, Alberta, Canada, T6X 0N9
        • Recruiting
        • LEO Pharma Investigational Site
      • Edmonton, Alberta, Canada, T5J 3S9
        • Recruiting
        • LEO Pharma Investigational Site
      • Red Deer, Alberta, Canada, T4P 1K4
        • Recruiting
        • LEO Pharma Investigational Site
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Recruiting
        • LEO Pharma Investigational Site
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 1G9
        • Recruiting
        • LEO Pharma Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8L 3C3
        • Recruiting
        • LEO Pharma Investigational Site
      • Kingston, Ontario, Canada, K7L 2V7
        • Recruiting
        • LEO Pharma Investigational Site
      • Richmond Hill, Ontario, Canada, L4B 1A5
        • Recruiting
        • LEO Pharma Investigational Site
      • Toronto, Ontario, Canada, M2N 3A6
        • Recruiting
        • LEO Pharma Investigational Site
      • Windsor, Ontario, Canada, N8T 1E6
        • Recruiting
        • LEO Pharma Investigational Site
    • Quebec
      • Laval, Quebec, Canada, H7N 6L2
        • Withdrawn
        • LEO Pharma Investigational Site
      • Saint-Jérôme, Quebec, Canada, J7Z 7E2
        • Recruiting
        • LEO Pharma Investigational Site
  • Korea, Republic of
      • Daegu, Korea, Republic of, 41944
        • Recruiting
        • LEO Pharma Investigational Site
      • Daejeon, Korea, Republic of, 35015
        • Recruiting
        • LEO Pharma Investigational Site
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • LEO Pharma Investigational Site
      • Seoul, Korea, Republic of, 04763
        • Recruiting
        • LEO Pharma Investigational Site
      • Seoul, Korea, Republic of, 05030
        • Recruiting
        • LEO Pharma Investigational Site
      • Seoul, Korea, Republic of, 05278
        • Recruiting
        • LEO Pharma Investigational Site
      • Seoul, Korea, Republic of, 4564
        • Recruiting
        • LEO Pharma Investigational Site
    • Gangwon-do
      • Wonju, Gangwon-do, Korea, Republic of, 26426
        • Recruiting
        • LEO Pharma Investigational Site
    • Gyeonggi-do
      • Ansan-si, Gyeonggi-do, Korea, Republic of, 15355
        • Recruiting
        • LEO Pharma Investigational Site
    • Gyeongsangnam-do
      • Yangsan, Gyeongsangnam-do, Korea, Republic of, 05278
        • Recruiting
        • LEO Pharma Investigational Site
  • United Kingdom
    • Avon
      • Bath, Avon, United Kingdom, BA1 3NG
        • Recruiting
        • LEO Pharma Investigational Site
    • Greater Manchester
      • Salford, Greater Manchester, United Kingdom
        • Recruiting
        • LEO Pharma Investigational Site
    • North Yorkshire
      • Middlesborough, North Yorkshire, United Kingdom, TS4 3BW
        • Recruiting
        • LEO Pharma Investigational Site
    • West Midlands
      • Dudley, West Midlands, United Kingdom, DY1 2HQ
        • Recruiting
        • LEO Pharma Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Recruiting
        • LEO Pharma Investigational Site
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916
        • Recruiting
        • LEO Pharma Investigational Site
    • California
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • LEO Pharma Investigational Site
      • Los Angeles, California, United States, 90025
        • Recruiting
        • LEO Pharma Investigational Site
      • Sacramento, California, United States, 95816
        • Recruiting
        • LEO Pharma Investigational Site
    • Florida
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • LEO Pharma Investigational Site
      • Tampa, Florida, United States, 33609
        • Recruiting
        • LEO Pharma Investigational Site
    • Indiana
      • Plainfield, Indiana, United States, 46168
        • Recruiting
        • LEO Pharma Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Recruiting
        • LEO Pharma Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Recruiting
        • LEO Pharma Investigational Site
    • Maine
      • Bangor, Maine, United States, 04401
        • Recruiting
        • LEO Pharma Investigational Site
    • Michigan
      • Caledonia, Michigan, United States, 49316
        • Recruiting
        • LEO Pharma Investigational Site
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Recruiting
        • LEO Pharma Investigational Site
    • New York
      • Cortland, New York, United States, 13045
        • Recruiting
        • LEO Pharma Investigational Site
      • New York, New York, United States, 10075
        • Recruiting
        • LEO Pharma Investigational Site
    • Ohio
      • Toledo, Ohio, United States, 43617
        • Recruiting
        • LEO Pharma Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Recruiting
        • LEO Pharma Investigational Site
      • Portland, Oregon, United States, 97201
        • Recruiting
        • LEO Pharma Investigational Site
    • South Carolina
      • North Charleston, South Carolina, United States, 29420
        • Recruiting
        • LEO Pharma Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37211
        • Recruiting
        • LEO Pharma Investigational Site
    • Texas
      • Dallas, Texas, United States, 75225
        • Recruiting
        • LEO Pharma Investigational Site
      • Frisco, Texas, United States, 75034
        • Recruiting
        • LEO Pharma Investigational Site
      • San Antonio, Texas, United States, 78213
        • Recruiting
        • LEO Pharma Investigational Site
      • Webster, Texas, United States, 77598
        • Recruiting
        • LEO Pharma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tralokinumab
Tralokinumab is administered for 32 weeks (16 weeks double-blinded period + 16 weeks open-label period)
Drug: Tralokinumab
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 Comparator: Placebo + tralokinumab
Placebo is administered for 16 weeks (double-blinded period) prior to roll-over to a 16 weeks open-label period where tralokinumab is administered
Drug: Placebo
After a loading dose under the skin (s.c.) at baseline, trial participants are administered a placebo dose every two weeks for 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Having a decrease in HECSI of at least 75% (HECSI-75)
Time Frame: From baseline (Day 1) to Week 16
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.
From baseline (Day 1) to Week 16
Having a decrease in HECSI of at least 50% (HECSI-50)
Time Frame: From baseline to Week 16
From baseline to Week 16
Having a decrease in HECSI of at least 90% (HECSI-90)
Time Frame: From baseline to Week 16
From baseline to Week 16
Percentage change in HECSI score
Time Frame: From baseline to Week 16
From baseline to Week 16
Having a ≥2-point reduction in IGA-AHE score
Time Frame: From baseline to Week 16
From baseline to Week 16
Reduction in HESD itch score (weekly average) of ≥4 points
Time Frame: From baseline to Week 16
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.
From baseline to Week 16
Reduction in HESD pain score (weekly average) of ≥4 points
Time Frame: From baseline to Week 16
Among subjects with a baseline HESD pain score (weekly average) ≥4 points.
From baseline to Week 16
Percentage change in HEIS score
Time Frame: From baseline to Week 16
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').
From baseline to Week 16
Percentage change in DLQI score
Time Frame: From baseline to Week 16
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').
From baseline to Week 16
Percentage change in HESD itch score (weekly average)
Time Frame: From baseline to Week 16
From baseline to Week 16
Percentage change in HESD pain score (weekly average)
Time Frame: From baseline to Week 16
From baseline to Week 16
Change in WPAI+CIQ:AHE domain scores
Time Frame: From baseline to Week 16
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.
From baseline to Week 16
Number of treatment-emergent adverse events
Time Frame: From baseline to Week 16
From baseline to Week 16
IGA-AHE score of 0 (clear) or 1 (almost clear)
Time Frame: At Week 32
At Week 32
Having a decrease in HECSI of at least 75% (HECSI-75)
Time Frame: From baseline to Week 32
From baseline to Week 32
Reduction in HESD itch score (weekly average) of ≥4 points
Time Frame: From baseline to Week 32
From baseline to Week 32
Reduction in HESD pain score (weekly average) of ≥4 points
Time Frame: From baseline to Week 32
Among subjects with a baseline HESD pain score (weekly average) ≥4 points
From baseline to Week 32
Percentage change in HEIS score
Time Frame: From baseline to Week 32
From baseline to Week 32
Percentage change in DLQI score
Time Frame: From baseline to Week 32
From baseline to Week 32
Change in WPAI+CIQ:AHE domain scores
Time Frame: From baseline to Week 32
From baseline to Week 32
Number of treatment-emergent adverse events during the open-label treatment period
Time Frame: Week 16 to Week 32
Week 16 to Week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Investigators

  • Study Director: Medical Expert, LEO Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

March 22, 2027

Study Registration Dates

First Submitted

July 13, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Actual)

July 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP0162-2328
  • U1111-1285-7014 (Other Identifier: World Health Organization (WHO))
  • 2022-502653-34-00 (Other Identifier: European Medicines Agency (EMA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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