Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 12 of 12

List	Outcome	Time frame	Description
Primary	Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 (Centrally Read)	Baseline (Day 1) and at Week 52	Total endoscopic nasal polyps (NP) score evaluated the size and extent of nasal polyps via endoscopy. The assessments were performed by central video image recordings of nasal endoscopy. The right and left nostrils were scored from 0 to 4 (0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle concha; 2 = Polyps reaching below the lower border of the middle turbinate; 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha; and 4 = Large polyps causing complete obstruction of the inferior meatus). The scores were graded based on NP size, recorded as sum of the right and left nostril scores and ranges from 0 (no polyps) to 8 (large polyps), calculated by summing the scores \[0 to 4\] in each nostril; with higher scores indicating worse status. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.
Primary	Change From Baseline in Mean Nasal Obstruction Score Using Verbal Response Scale From Week 49 Through to Week 52	Baseline (Day 1) and from Week 49 to Week 52	This endpoint evaluated the change from baseline in the mean nasal obstruction score using a Verbal Response Scale (VRS) from Week 49 through to Week 52. Participants used a VRS to rate nasal obstruction severity, with scores averaged over the specified period to assess treatment impact on nasal obstruction symptoms. Participants were asked to indicate the severity of nasal obstruction at their worst over the last 24 hours using a 4-point VRS, with options of no symptoms, mild symptoms, moderate symptoms, and severe symptoms. This was scored on a scale ranging from 0 (no symptoms) to 3 (severe symptoms), with higher scores indicating worse status. The average of daily scores in 4-weekly intervals were calculated and data are presented for Weeks 49-52. Baseline was defined as the average score from 28 days of electronic diary (eDiary) data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.
Secondary	Change From Baseline in Mean Symptom Score for Rhinorrhea (Runny Nose) Using Verbal Response Scale From Week 49 Through to Week 52	Baseline (Day 1) and from Week 49 to Week 52	Participants were asked to indicate the severity of rhinorrhea (runny nose) at their worst over the last 24 hours using a 4-point VRS, with options of no symptoms, mild symptoms, moderate symptoms, and severe symptoms. This was scored on a scale ranging from 0 (no symptoms) to 3 (severe symptoms). Higher scores indicate the worse status. The average of daily scores in 4-weekly intervals were calculated and data are presented for Weeks 49-52. Baseline was defined as the average score from 28 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.
Secondary	Change From Baseline in Mean Symptom Score for Loss of Smell Using Verbal Response Scale From Week 49 Through to Week 52	Baseline (Day 1) and from Week 49 to Week 52	Participants were asked to indicate the severity of loss of smell at their worst over the last 24 hours using a 4-point VRS, with options of no symptoms, mild symptoms, moderate symptoms, and severe symptoms. This was scored on a scale ranging from 0 (no symptoms) to 3 (severe symptoms). Higher score indicates worse status. The average of daily scores in 4-weekly intervals were calculated and data are presented for Weeks 49-52. Baseline was defined as the average score from 28 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.
Secondary	Change From Baseline in Lund Mackay Computerized Tomography (CT) Score at Week 52	Baseline (Day 1) and at Week 52	The LMK CT scoring system is based on CT imaging of the sinuses with points given for degree of opacification: 0 =normal, 1 = partial opacification, 2 = total opacification. These points were applied to the maxillary, anterior ethmoid, posterior ethmoid, sphenoid, frontal sinus on each side (right and left). The osteomeatal complex (OC) is graded as 0 = not occluded, or 2 = occluded. The range for the total LMK CT score is therefore 0 (normal) to 24 (total opacification) when summed across both sides with higher scores indicating more severe disease. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.
Secondary	Change From Baseline in Sino-nasal Outcome Test (SNOT)-22 Total Score at Week 52	Baseline (Day 1) and at Week 52	Sino-nasal outcome test-22 is a 22-item measure of disease specific health related quality of life (HRQoL). Participants were asked to rate the severity of their condition on each of the 22 items over the previous 2 weeks using a 6-point rating scale of 0-5 including: 0 = Not present/no problem; 1 = Very mild problem; 2 = Mild or slight problem; 3 = Moderate problem; 4 = Severe problem; 5 = Problem as "bad as it can be". The scores for each question were summed up to derive the total score range for the SNOT-22 was from 0 (high quality of life) to 110 (worst quality of life), where higher scores indicate worse quality of life. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.
Secondary	Change From Baseline in Mean Nasal Obstruction Score (Verbal Response Scale) From Week 21 Through to Week 24	Baseline (Day 1) and from Week 21 to Week 24	Participants were asked to indicate the severity of nasal obstruction at its worst over the previous 24 hours using a 4-point VRS. The response options were no symptoms, mild symptoms, moderate symptoms, and severe symptoms, scored on a scale ranging from 0 (no symptoms) to 3 (severe symptoms). Higher scores indicate more severe status. The average of daily scores in 4-weekly intervals were calculated and data are presented for Weeks 21-24. Baseline was defined as the average score from 28 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.
Secondary	Change From Baseline in Total Endoscopic Nasal Polyps Score at Week 26	Baseline (Day 1) and at Week 26	Total endoscopic nasal polyps (NP) score evaluated the size and extent of nasal polyps via endoscopy. The assessments were performed by central video image recordings of nasal endoscopy. The right and left nostrils were scored from 0 to 4 (0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle concha; 2 = Polyps reaching below the lower border of the middle turbinate; 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha; and 4 = Large polyps causing complete obstruction of the inferior meatus). The scores were graded based on NP size, recorded as sum of the right and left nostril scores and ranges from 0 (no polyps) to 8 (large polyps), calculated by summing the scores \[0 to 4\] in each nostril; with higher scores indicating worse status. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.
Secondary	Percentage of Participants Requiring First Nasal Surgery (Actual or Entry on Waiting List) or Disease-Modulating Medication for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Up to Week 52	Up to Week 52	Nasal polyp surgery is defined as any procedure involving instruments resulting in incision and removal of tissue from the nasal cavity (for example polypectomy). Time to first nasal polyp surgery (actual or entry on waiting list) or disease-modulating medication for CRSwNP up to Week 52 was assessed in a pre-specified pooled analysis across replicate studies 217095 (NCT05274750) and 218079 (NCT05281523). The percentage of participants with nasal surgery or disease-modulating medication for CRSwNP and corresponding 95% CI have been presented, calculated using the Kaplan-Meier method.
Secondary	Percentage of Participants Requiring First Nasal Surgery (Actual) or Disease-Modulating Medication for CRSwNP up to Week 52	Up to Week 52	Nasal polyp surgery is defined as any procedure involving instruments resulting in incision and removal of tissue from the nasal cavity (for example polypectomy).Time to first nasal polyp surgery (actual) or disease-modulating medication for CRSwNP up to week 52 was assessed in a pre-specified pooled analysis across replicate studies 217095 (NCT05274750) and 218079 (NCT05281523). The percentage of participants with nasal surgery or disease-modulating medication for CRSwNP and corresponding 95% CI have been presented, calculated using the Kaplan-Meier method.
Secondary	Percentage of Participants Requiring at Least One Course of Systemic Corticosteroids or Disease-Modulating Medication for CRSwNP or Nasal Surgery (Actual) During the Week 52 Treatment Period	Up to Week 52	The percentage of participants requiring at least 1 course of systemic corticosteroids (CS) or disease-modulating medication for CRSwNP or nasal surgery (actual) during the Week 52 treatment period was assessed in a pre-specified pooled analysis across replicate studies 217095 (NCT05274750) and 218079 (NCT05281523). Percentage of participants with nasal surgery or course of systemic CS for CRSwNP have been presented.
Secondary	Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 52	Baseline (Day 1) and at Week 52	The ACQ-5 is a five-item questionnaire designed to be self-completed by the participants to assess the most common asthma symptoms. The 5 questions enquired to recall how their asthma had been during the previous week and to respond about the frequency and/or severity of symptoms (nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheezing). The overall ACQ-5 response option is the mean score of all 5 questions representing 0 with no impairment/limitation and 6 as total impairment/ limitation. Higher scores indicated more limitations and lower scores with better asthma control. Impact on asthma control in the subgroup of participants with an ACQ-5 score greater than 0.75 (indicating partially or not well-controlled) at baseline was assessed in a pre-specified pooled analysis across replicate studies 217095 (NCT05274750) and 218079 (NCT05281523). Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.

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

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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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