Respiratory tract diseases
Conditions
Brief summary
Change from baseline in sinus (maxillary, ethmoid) percent opacification volume assessed by CT scan
Detailed description
Change from baseline in the sTSS, Change from baseline in nasal congestion (NC) severity score, Anterior/posterior rhinorrhea severity score, Facial pain/pressure severity score, and Loss of smell severity score using the CRSsNP daily e diary, Change from baseline in SNOT22 total score, Change from baseline in sinus opacification as measured by the Lund-Mackay (LMK) score and the modified LMK score, Incidence of (treatment-emergent adverse events (TEAEs), treatment-emergent adverse events of special interest (TEAESIs), treatment emergent serious adverse events (TESAEs), and treatment-emergent adverse events (TEAEs) leading to intervention discontinuation, Itepekimab concentration in serum, Incidence of treatment-emergent (TE) anti-itepekimab antibodies responses
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in sinus (maxillary, ethmoid) percent opacification volume assessed by CT scan | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the sTSS, Change from baseline in nasal congestion (NC) severity score, Anterior/posterior rhinorrhea severity score, Facial pain/pressure severity score, and Loss of smell severity score using the CRSsNP daily e diary, Change from baseline in SNOT22 total score, Change from baseline in sinus opacification as measured by the Lund-Mackay (LMK) score and the modified LMK score, Incidence of (treatment-emergent adverse events (TEAEs), treatment-emergent adverse events of special interest (TEAESIs), treatment emergent serious adverse events (TESAEs), and treatment-emergent adverse events (TEAEs) leading to intervention discontinuation, Itepekimab concentration in serum, Incidence of treatment-emergent (TE) anti-itepekimab antibodies responses | — |
Countries
Belgium, France, Italy, Poland, Portugal, Romania, Spain