Trial · NCT07903194
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Bilateral Nasal Polyp Score (NPS) | Baseline and Week 24 | Nasal endoscopy with central reading evaluates bilateral nasal polyp size. Each nostril is scored from 0 to 4, yielding a total bilateral Nasal Polyp Score (NPS) ranging from 0 to 8, where higher scores indicate larger polyp size. A negative change from baseline indicates improvement. |
| Primary | Change From Baseline in Nasal Congestion Score (NCS) | Baseline and Week 24 | Participants record their previous day's nasal congestion severity daily on a scale from 0 to 3, where higher scores indicate more severe nasal congestion. The Nasal Congestion Score (NCS) baseline is typically calculated as the mean of the 7 days prior to randomization; if fewer than 4 days are recorded within those 7 days, the mean of the most recent 4 days of records prior to randomization is used. Post-baseline scores are calculated as the mean of at least 8 daily records within the 14 days prior to the scheduled visit. A negative change relative to baseline indicates improvement. |
| Secondary | Change From Baseline in Bilateral Nasal Polyp Score (NPS) (Other Than Week 24) | Baseline and Weeks 4, 8, 12, 16, 20, 28, 32, 40, 48, 52, and 60 | Nasal endoscopy with central reading evaluates bilateral nasal polyp size. Each nostril is scored from 0 to 4, yielding a total bilateral Nasal Polyp Score (NPS) ranging from 0 to 8, where higher scores indicate larger polyp size. A negative change from baseline indicates improvement. |
| Secondary | Percentage of Participants With at Least a 1-Point Improvement From Baseline in Nasal Polyp Score (NPS) | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60 | Nasal endoscopy with central reading evaluates bilateral nasal polyp size. Each nostril is scored from 0 to 4, yielding a total bilateral Nasal Polyp Score (NPS) ranging from 0 to 8, where higher scores indicate larger polyp size; a negative change relative to baseline indicates improvement. The percentage of participants with a reduction of at least 1 point from baseline in NPS is calculated at each designated visit. |
| Secondary | Percentage of Participants With at Least a 2-Point Improvement From Baseline in Nasal Polyp Score (NPS) | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60 | Nasal endoscopy with central reading evaluates bilateral nasal polyp size. Each nostril is scored from 0 to 4, yielding a total bilateral Nasal Polyp Score (NPS) ranging from 0 to 8, where higher scores indicate larger polyp size; a negative change relative to baseline indicates improvement. The percentage of participants with a reduction of at least 2 points from baseline in NPS is calculated at each designated visit. |
| Secondary | Change From Baseline in Nasal Congestion Score (NCS) (Other Than Week 24) | Baseline and Weeks 4, 8, 12, 16, 20, 28, 32, 40, 48, 52, and 60 | Participants record their previous day's nasal congestion severity daily on a scale from 0 to 3, where higher scores indicate more severe nasal congestion. The Nasal Congestion Score (NCS) baseline is typically calculated as the mean of the 7 days prior to randomization; if fewer than 4 days are recorded within those 7 days, the mean of the most recent 4 days of records prior to randomization is used. Post-baseline scores are calculated as the mean of at least 8 daily records within the 14 days prior to the scheduled visit. A negative change relative to baseline indicates improvement. |
| Secondary | Percentage of Participants With at Least a 1-Point Improvement From Baseline in Nasal Congestion Score (NCS) | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60 | Participants record their previous day's nasal congestion severity daily on a scale from 0 to 3, where higher scores indicate more severe nasal congestion. The Nasal Congestion Score (NCS) baseline is typically calculated as the mean of the 7 days prior to randomization; if fewer than 4 days are recorded within those 7 days, the mean of the most recent 4 days of records prior to randomization is used. Post-baseline scores are calculated as the mean of at least 8 daily records within the 14 days prior to the scheduled visit. A negative change relative to baseline indicates improvement. The percentage of participants with a reduction of at least 1 point from baseline in NCS is calculated at each designated visit. |
| Secondary | Change From Baseline in Total Symptom Score (TSS) | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60 | Total Symptom Score (TSS) comprises three items: nasal congestion, loss of smell, and rhinorrhea; scores for anterior rhinorrhea and posterior rhinorrhea are averaged first. Each item is scored 0-3, with a total score of 0-9, where higher scores indicate more severe symptoms. Baseline is the mean of the week prior to randomization, and post-baseline is the mean of the two weeks prior to the visit. If fewer than 4 days are recorded within the 7 days prior to randomization, baseline is the mean of the most recent 4 recorded days prior to randomization; at least 8 days of records are required within the 14 days prior to a post-baseline visit. The Week 24 assessment is a prespecified key secondary endpoint. |
| Secondary | Change From Baseline in Loss of Smell (Hyposmia/Anosmia) Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60 | Participants daily assess the severity of loss of smell for the previous day. This score is identical to the smell item in the Total Symptom Score (TSS), ranging from 0-3, where higher scores indicate more severe symptoms. Baseline is the mean of the week prior to randomization, and post-baseline is the mean of the two weeks prior to the visit. If fewer than 4 days are recorded within the 7 days prior to randomization, baseline is the mean of the most recent 4 recorded days prior to randomization; at least 8 days of records are required within the 14 days prior to a post-baseline visit. The Week 24 assessment is a prespecified key secondary endpoint. |
| Secondary | Change From Baseline in University of Pennsylvania Smell Identification Test (UPSIT) Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, and 60 | A 40-item odor identification test, the University of Pennsylvania Smell Identification Test (UPSIT) awards 1 point for each correctly identified odor, with a total score ranging from 0 to 40, where higher scores indicate better olfactory function. The Week 24 assessment is a prespecified key secondary endpoint. |
| Secondary | Change From Baseline in Sinus Computed Tomography (CT) Lund-Mackay Score | Baseline (prior to first dose) and Weeks 24 and 52 | Evaluated by central reading of sinus computed tomography (CT) scans. The bilateral Lund-Mackay score ranges from 0 to 24, where higher scores indicate more severe disease. Baseline values are based on central reading results of available CT scans prior to randomization/first dose that meet protocol quality and time-window requirements; if a qualified CT scan was completed during the screening or run-in period, repeated scanning at baseline is not required. The Week 24 assessment is a prespecified key secondary endpoint. |
| Secondary | Percentage of Participants Receiving Rescue Treatment | Baseline up to Week 24, and Baseline up to Week 60 | Calculates the percentage of participants receiving rescue treatment with systemic corticosteroids or nasal polyp surgery due to worsening signs or symptoms of chronic rhinosinusitis with nasal polyps (CRSwNP). The cumulative percentage through Week 24 is a prespecified key secondary endpoint; rescue treatments during the subsequent treatment period and safety follow-up period are also recorded. |
| Secondary | Time to First Improvement of at Least 1 Point From Baseline in Nasal Polyp Score (NPS) | Baseline up to Week 60; assessment visits are at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60 | Time from baseline to the first occurrence of a reduction of at least 1 point from baseline in bilateral Nasal Polyp Score (NPS) observed at scheduled nasal endoscopy assessment visits. |
| Secondary | Time to First Rescue Treatment | Baseline up to Week 60 | Time from baseline to the first administration of rescue treatment with systemic corticosteroids or nasal polyp surgery due to worsening of chronic rhinosinusitis with nasal polyps (CRSwNP). |
| Secondary | Change From Baseline in 22-Item Sino-Nasal Outcome Test (SNOT-22) Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, and 60 | The 22-item Sino-Nasal Outcome Test (SNOT-22) is a participant-reported questionnaire with 22 items scored from 0 to 5 each, yielding a total score of 0 to 110, where higher scores indicate greater symptom severity and quality-of-life impact. The recall period covers the past 2 weeks. The Week 24 assessment is a prespecified key secondary endpoint. |
| Secondary | Change From Baseline in EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, and 60 | The EuroQol Visual Analogue Scale (EQ VAS) component of the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire records participant-rated health status on a scale from 0 to 100, where 0 represents the worst health imaginable and 100 represents the best health imaginable. |
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.
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