CompletedNot Applicable

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

Czechia146 participantsStarted 2022-12-30

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: At Week 24

Trial details

NCT IDNCT05527964

SponsorSanofi

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-06-16

View on ClinicalTrials.gov More Atopic Dermatitis trials