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Completed

NCT Number: NCT05527964

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

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

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site: Bulovka University Hospital

Prague, 180 81, Czechia

About this study

28 weeks

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in disease activity (Eczema Area and Severity Index (EASI) score)

    Time frame: At Week 16 and Week 24

  2. 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

  3. Change in Dermatology Life Quality Index (DLQI score)

    Time frame: At Week 16 and Week 24

  4. Change in Family Dermatology Life Quality Index (FDLQI score)

    Time frame: At Week 16

  5. Change in sleep quality (Jenkins Sleep Evaluation Questionnaire (JSEQ) score)

    Time frame: At Week 16 and Week 24

  6. Change in anxiety (Clinically Useful Anxiety Outcome Scale (CUXOS) score)

    Time frame: At Week 16 and Week 24

  7. Change in depression (Clinically Useful Depression Outcome Scale (CUDOS) score)

    Time frame: At Week 16 and Week 24

  8. Total number of adverse events

    Time frame: At Week 16 and Week 24

  9. Number of serious adverse events (SAEs)

    Time frame: At Week 16 and Week 24

  10. Number of non-serious adverse events (non-SAEs)

    Time frame: At Week 16 and Week 24

  11. Total number of discontinuations

    Time frame: At Week 16 and Week 24

  12. Reasons for discontinuations

    Time frame: At Week 16 and Week 24

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 6, 2022
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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