Trial · NCT06691113
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in sinus (maxillary, ethmoid) percent opacification volume assessed by CT scan | Baseline to End of Treatment (EOT) (Week 24) | Change from baseline in sinus inflammation as assessed by Computerized Tomography (CT) scan of the sinuses in the itepekimab-- compared to placebo-- treated study participants on the background of intranasal corticosteroid (INCS). |
| Secondary | Change from baseline in the sTSS | Baseline to EOT (Week 24) | The CRSsNP sinus Total Symptom Score (sTSS) is a composite score derived from nasal congestion (NC), anterior/posterior rhinorrhea, and facial pain/pressure. The total score ranges from 0 to 9 with higher scores indicating greater overall symptom severity. |
| Secondary | Change from baseline in nasal congestion (NC) severity score using the CRSsNP daily ediary | Baseline to EOT (Week 24) | The CRSsNP sinonasal symptom diary is designed to assess the severity of CRS sinonasal symptoms on daily basis. These symptoms include NC/obstruction, anterior rhinorrhea and posterior rhinorrhea, facial pain/pressure, loss of smell, and headache. Each of the individual items of the diary are scored from 0 ("No symptoms") to 3 ("Severe symptoms - symptoms that are hard to tolerate, cause interference with activities or daily living"). Higher scores on the items of the individual symptoms denote greater symptom severity. |
| Secondary | Change from baseline in anterior/posterior rhinorrhea severity score using the CRSsNP daily ediary | Baseline to EOT (Week 24) | The CRSsNP sinonasal symptom diary is designed to assess the severity of CRS sinonasal symptoms on daily basis. These symptoms include NC/obstruction, anterior rhinorrhea and posterior rhinorrhea, facial pain/pressure, loss of smell, and headache. Each of the individual items of the diary are scored from 0 ("No symptoms") to 3 ("Severe symptoms - symptoms that are hard to tolerate, cause interference with activities or daily living"). Higher scores on the items of the individual symptoms denote greater symptom severity. |
| Secondary | Change from baseline in facial pain/pressure severity score using the CRSsNP daily ediary | Baseline to EOT (Week 24) | The CRSsNP sinonasal symptom diary is designed to assess the severity of CRS sinonasal symptoms on daily basis. These symptoms include NC/obstruction, anterior rhinorrhea and posterior rhinorrhea, facial pain/pressure, loss of smell, and headache. Each of the individual items of the diary are scored from 0 ("No symptoms") to 3 ("Severe symptoms - symptoms that are hard to tolerate, cause interference with activities or daily living"). Higher scores on the items of the individual symptoms denote greater symptom severity. |
| Secondary | Change from baseline in loss of smell severity score using the CRSsNP daily ediary | Baseline to EOT (Week 24) | The CRSsNP sinonasal symptom diary is designed to assess the severity of CRS sinonasal symptoms on daily basis. These symptoms include NC/obstruction, anterior rhinorrhea and posterior rhinorrhea, facial pain/pressure, loss of smell, and headache. Each of the individual items of the diary are scored from 0 ("No symptoms") to 3 ("Severe symptoms - symptoms that are hard to tolerate, cause interference with activities or daily living"). Higher scores on the items of the individual symptoms denote greater symptom severity. |
| Secondary | Change from baseline in SNOT-22 total score | Baseline to EOT (Week 24) | The Sino-Nasal Outcome Test-22-Items (SNOT-22) is a patient-reported outcome questionnaire designed to assess the impact of chronic rhinosinusitis (CRS) on patients' Health-Related Quality of Life (HRQoL). It has 22 items covering symptoms, social/emotional impact, productivity, and sleep consequences of CRS. A global score ranges from 0 to 110 with higher score indicating greater rhinosinusitis-related health burden. |
| Secondary | Change from baseline in sinus opacification as measured by the Lund-Mackay (LMK) score and the modified LMK score | Baseline to EOT (Week 24) | The LMK and the modified LMK scoring systems are based on points given for degree of opacification, which are applied to the maxillary, anterior ethmoid, posterior ethmoid, sphenoid, frontal sinus on each side. The osteomeatal complex is graded as 0 = not occluded, or 2 = occluded, deriving a maximum score of 12 per side. |
| Secondary | Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent adverse events of special interest (TEAESIs), treatment emergent serious adverse events (TESAEs), and TEAEs leading to intervention discontinuation | Baseline up to End of Study (EOS) (Week 44) | |
| Secondary | Itepekimab concentration in serum | Baseline to EOS (Week 44) | |
| Secondary | Incidence of treatment-emergent (TE) anti-itepekimab antibodies responses | Baseline to EOS (Week 44) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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