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

August 14, 2025 updated by: Sanofi

The Influence of Specific Targeted Therapy on Subject and Family Quality of Life, Anxiety, Depression and Sleep Quality in Patients With Severe Refractory Atopic Dermatitis in the Czech Republic

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 Overview

Status

Completed

Conditions

Detailed Description

28 weeks

Study Type

Observational

Enrollment (Actual)

146

Contacts and Locations

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

Study Locations

  • Czechia
      • Prague, Czechia, 180 81
        • Investigational Site: Bulovka University Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients eligible for Dupixent therapy of atopic dermatitis (AD) according to the current summary of product characteristics (SPC) and reimbursement criteria given by the State Institute for Drug Control (SUKL) in Czech Republic

Description

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.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients with severe refractory atopic dermatitis
Patients eligible for Dupixent therapy of AD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The regression coefficient for at least 75% reduction in the Eczema Area and Severity Index score (EASI75) at week 24 adjusted to baseline characteristics predicting the change in EQ-5D utility
Time Frame: At Week 24
At Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in disease activity (Eczema Area and Severity Index (EASI) score)
Time Frame: At Week 16 and Week 24
At Week 16 and Week 24
Change in subject generic quality of life (European Quality of Life Five Dimension questionnaire (EQ-5D) utility)
Time Frame: At Week 16 and Week 24
At Week 16 and Week 24
Change in Dermatology Life Quality Index (DLQI score)
Time Frame: At Week 16 and Week 24
At Week 16 and Week 24
Change in Family Dermatology Life Quality Index (FDLQI score)
Time Frame: At Week 16
At Week 16
Change in sleep quality (Jenkins Sleep Evaluation Questionnaire (JSEQ) score)
Time Frame: At Week 16 and Week 24
At Week 16 and Week 24
Change in anxiety (Clinically Useful Anxiety Outcome Scale (CUXOS) score)
Time Frame: At Week 16 and Week 24
At Week 16 and Week 24
Change in depression (Clinically Useful Depression Outcome Scale (CUDOS) score)
Time Frame: At Week 16 and Week 24
At Week 16 and Week 24
Total number of adverse events
Time Frame: At Week 16 and Week 24
At Week 16 and Week 24
Number of serious adverse events (SAEs)
Time Frame: At Week 16 and Week 24
At Week 16 and Week 24
Number of non-serious adverse events (non-SAEs)
Time Frame: At Week 16 and Week 24
At Week 16 and Week 24
Total number of discontinuations
Time Frame: At Week 16 and Week 24
At Week 16 and Week 24
Reasons for discontinuations
Time Frame: At Week 16 and Week 24
At Week 16 and Week 24

Collaborators and Investigators

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

Sponsor

Sanofi

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

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)

December 30, 2022

Primary Completion (Actual)

June 16, 2025

Study Completion (Actual)

June 16, 2025

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 6, 2022

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 14, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBS17350
  • U1111-1279-3216 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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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