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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1279-3216 | Registry Identifier | ICTRP |
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Assessment of the relationship between treatment response (EASI75) and change in quality of life (EQ-5D) by week 24.
Description of the:
28 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with severe refractory atopic dermatitis | Patients eligible for Dupixent therapy of AD |
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| Measure | Description | 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 | At Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in disease activity (Eczema Area and Severity Index (EASI) score) | At Week 16 and Week 24 | |
| Change in subject generic quality of life (European Quality of Life Five Dimension questionnaire (EQ-5D) utility) | At Week 16 and Week 24 |
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Inclusion Criteria:
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.
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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
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site: Bulovka University Hospital | Prague | 180 81 | Czechia |
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
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Change in Dermatology Life Quality Index (DLQI score) | At Week 16 and Week 24 |
| Change in Family Dermatology Life Quality Index (FDLQI score) | At Week 16 |
| Change in sleep quality (Jenkins Sleep Evaluation Questionnaire (JSEQ) score) | At Week 16 and Week 24 |
| Change in anxiety (Clinically Useful Anxiety Outcome Scale (CUXOS) score) | At Week 16 and Week 24 |
| Change in depression (Clinically Useful Depression Outcome Scale (CUDOS) score) | At Week 16 and Week 24 |
| Total number of adverse events | At Week 16 and Week 24 |
| Number of serious adverse events (SAEs) | At Week 16 and Week 24 |
| Number of non-serious adverse events (non-SAEs) | At Week 16 and Week 24 |
| Total number of discontinuations | At Week 16 and Week 24 |
| Reasons for discontinuations | At Week 16 and Week 24 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |