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

Description

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.

Conditions

Atopic Dermatitis, Atopic Hand Eczema

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Atopic Dermatitis
Intervention / Treatment

-

Contacts and Locations

Birmingham

LEO Pharma Investigational Site, Birmingham, Alabama, United States, 35209

Fort Smith

LEO Pharma Investigational Site, Fort Smith, Arkansas, United States, 72916

Fountain Valley

LEO Pharma Investigational Site, Fountain Valley, California, United States, 92708

Los Angeles

LEO Pharma Investigational Site, Los Angeles, California, United States, 90025

Sacramento

LEO Pharma Investigational Site, Sacramento, California, United States, 95816

Farmington

LEO Pharma Investigational Site, Farmington, Connecticut, United States, 06032

Hialeah

LEO Pharma Investigational Site, Hialeah, Florida, United States, 33012

Tampa

LEO Pharma Investigational Site, Tampa, Florida, United States, 33609

Plainfield

LEO Pharma Investigational Site, Plainfield, Indiana, United States, 46168

Louisville

LEO Pharma Investigational Site, Louisville, Kentucky, United States, 40217

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

LEO Pharma,

Medical Expert, STUDY_DIRECTOR, LEO Pharma

Study Record Dates

2027-03-22