Atopic Dermatitis Clinical Trial
Official 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
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
| Status | Recruiting |
| Enrollment | 150 |
| Est. completion date | July 10, 2025 |
| Est. primary completion date | July 10, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | Investigational Site: Bulovka University Hospital | Prague |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi |
Czechia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | At Week 24 | ||
| Secondary | Change in disease activity (Eczema Area and Severity Index (EASI) score) | At Week 16 and Week 24 | ||
| Secondary | Change in subject generic quality of life (European Quality of Life Five Dimension questionnaire (EQ-5D) utility) | At Week 16 and Week 24 | ||
| Secondary | Change in Dermatology Life Quality Index (DLQI score) | At Week 16 and Week 24 | ||
| Secondary | Change in Family Dermatology Life Quality Index (FDLQI score) | At Week 16 | ||
| Secondary | Change in sleep quality (Jenkins Sleep Evaluation Questionnaire (JSEQ) score) | At Week 16 and Week 24 | ||
| Secondary | Change in anxiety (Clinically Useful Anxiety Outcome Scale (CUXOS) score) | At Week 16 and Week 24 | ||
| Secondary | Change in depression (Clinically Useful Depression Outcome Scale (CUDOS) score) | At Week 16 and Week 24 | ||
| Secondary | Total number of adverse events | At Week 16 and Week 24 | ||
| Secondary | Number of serious adverse events (SAEs) | At Week 16 and Week 24 | ||
| Secondary | Number of non-serious adverse events (non-SAEs) | At Week 16 and Week 24 | ||
| Secondary | Total number of discontinuations | At Week 16 and Week 24 | ||
| Secondary | Reasons for discontinuations | At Week 16 and Week 24 |
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