This study is currently not recruiting participants.

A Study to Evaluate the Quality of Life of Male and Female Adult Patients With Severe Refractory Atopic Dermatitis Treated With Dupilumab in Czech Republic

Evaluating Quality of Life in Adults with Severe Refractory Atopic Dermatitis Using Investigational Treatment

Not Recruiting
18 years or above
All
Phase N/A
146 participants needed

Study Overview

Assessment of the relationship between treatment response (EASI75) and change in quality of life (EQ-5D) by week 24.

Description of the:

  • Change in disease activity after 16 and 24 weeks
  • Change in subject and family quality of life after 16 and 24 weeks
  • Change in sleep quality after 16 and 24 weeks
  • Change in anxiety after 16 and 24 weeks
  • Change in depression after 16 and 24 weeks
  • Safety and tolerability

Study Details

28 weeks

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Atopic Dermatitis
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  • Patient eligible for Dupixent therapy of AD according to the current SPC and reimbursement criteria given by the SUKL
  • Signed informed consent
  • 18 years and older (study questionnaires are validated for this age group). Patient is able to follow the prescribed regimen, routine follow-up visits and to fill the questionnaires

Exclusion Criteria:

  • Patient not eligible for Dupixent therapy of AD according to the current SPC and reimbursement criteria given by the SUKL.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

This study investigates severe refractory atopic dermatitis. It looks at how the condition affects people who have not responded to other treatments.

The study evaluates the relationship between treatment response and changes in quality of life, including disease activity, sleep, anxiety, depression, and safety.

  • Who can participate: Adults 18 years and older with severe refractory atopic dermatitis who are eligible for investigational medication therapy.
  • Study details: Participants will receive investigational medication and complete questionnaires about their quality of life. The study will look at changes in disease activity and overall well-being. An inactive substance that looks like the investigational medicine but does not contain any medicine may be used as a comparison.
  • Study timelines: The study will last 28 weeks.
Updated on 15 Aug 2025. Study ID: NCT05527964