SYF543d3e3146f74770929e0a1cf687242eRegistry ID: 2023-509815-10-00|UnknownPhase 4
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interventional
N/A
1 country
1
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 8, 2024
Actual (reported)Primary endpoint is the change in barrier sensitivity (Cell index) (1) at visit 1 (baseline) in stimulated versus unstimulated cells of patients suffering from CRSsNP or CRSwNP as compared to disease controls as well as in (2) CRSwNP patients at V1 and after 6 months of dupilumab treatment (V3).
Change in barrier sensitivity as described in primary endpoint in patients over time (0, 3 and 6 months)
Expression levels of tight junction proteins (by mass cytometry imaging – percentage of positive cells and intensity of staining) in selected biopsies and fixed cultured primary cells in diseased patients and compared to disease controls
Cytokine levels (pg/ml) in nasal mucosal lining fluids of diseased patients and compared to disease controls
Association of barrier sensitivity and cytokine levels
Microbiome (Diversity, Shannon index) in diseased patients and compared to disease controls
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Dupixent 300 mg solution for injection in pre-filled syringe
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
Dupixent 300 mg solution for injection in pre-filled pen
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Dupixent 300 mg solution for injection in pre-filled syringe
Named ingredient: dupilumab
View registry recordDupixent 300 mg solution for injection in pre-filled pen
Named ingredient: dupilumab
View registry recordMedical University Of Vienna
Vienna, 1090, Austria
Department of Ear, Nose and Throat Disease
First Submitted
January 8, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
Mechanisms of Smell Improvement With Dupilumab.
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