Trial Outcomes & Findings for Mechanisms of Smell Improvement With Dupilumab. (NCT NCT05964465)
NCT ID: NCT05964465
Last Updated: 2026-08-05
Results Overview
Subjects will have sinonasal endoscopy at baseline and every follow up visit. This procedure allows visual inspection of the sinus mucosal lining and grading of polyps, including the olfactory cleft. Results for each side will be recorded separately and combined for a final Olfactory Cleft Endoscopy Scale (OCES) that ranges from 0-20, with higher scores representing increased disease severity.
COMPLETED
PHASE4
60 participants
3 months post-treatment
2026-08-05
Participant Flow
Participant milestones
| Measure |
Treatment
The treatment group will receive dupilumab at 300mg SC Q2weeks. The first dose will be administered via subcutaneous injection in clinic at baseline. Subjects will self-administer study drug (dupilumab 300 mg) subcutaneous every 2 weeks after initial dosing at visit 2.
Dupilumab: Monoclonal antibody blocking interleukin 4 and interleukin 13
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|---|---|
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Overall Study
STARTED
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60
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Overall Study
COMPLETED
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59
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Treatment
The treatment group will receive dupilumab at 300mg SC Q2weeks. The first dose will be administered via subcutaneous injection in clinic at baseline. Subjects will self-administer study drug (dupilumab 300 mg) subcutaneous every 2 weeks after initial dosing at visit 2.
Dupilumab: Monoclonal antibody blocking interleukin 4 and interleukin 13
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|---|---|
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
Mechanisms of Smell Improvement With Dupilumab.
Baseline characteristics by cohort
| Measure |
Dupilumab
n=59 Participants
On Dupilumab
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|---|---|
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Age, Continuous
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53.4 years
STANDARD_DEVIATION 17.1 • n=20 Participants
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Sex: Female, Male
Female
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25 Participants
n=20 Participants
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Sex: Female, Male
Male
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34 Participants
n=20 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=20 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=20 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=20 Participants
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Race (NIH/OMB)
Black or African American
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14 Participants
n=20 Participants
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Race (NIH/OMB)
White
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40 Participants
n=20 Participants
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Race (NIH/OMB)
More than one race
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2 Participants
n=20 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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2 Participants
n=20 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=20 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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57 Participants
n=20 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
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PRIMARY outcome
Timeframe: Baseline and Week 12 (3 months post-treatment)Non-contrast sinus computed tomography (CT) scans were obtained at Baseline and Week 12. Volumetric analysis of the olfactory cleft was performed using previously described methods. Total olfactory cleft volume and air volume were measured to calculate percent olfactory cleft opacification as \[1 - (air volume/total olfactory cleft volume)\] × 100. Percent olfactory cleft opacification ranges from 0% to 100%, with higher values indicating greater olfactory cleft inflammation and disease severity and lower values indicating less inflammation and improvement.
Outcome measures
| Measure |
Treatment
n=57 Participants
The treatment group will receive dupilumab at 300mg SC Q2weeks. The first dose will be administered via subcutaneous injection in clinic at baseline. Subjects will self-administer study drug (dupilumab 300 mg) subcutaneous every 2 weeks after initial dosing at visit 2.
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|---|---|
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Change in Volumetric Olfactory Cleft Opacification Based on CT.
Baseline
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78.1 Percent (%)
Standard Deviation 20.0
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Change in Volumetric Olfactory Cleft Opacification Based on CT.
Week 12
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60.1 Percent (%)
Standard Deviation 18.9
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PRIMARY outcome
Timeframe: 3 months post-treatmentSubjects will have sinonasal endoscopy at baseline and every follow up visit. This procedure allows visual inspection of the sinus mucosal lining and grading of polyps, including the olfactory cleft. Results for each side will be recorded separately and combined for a final Olfactory Cleft Endoscopy Scale (OCES) that ranges from 0-20, with higher scores representing increased disease severity.
Outcome measures
| Measure |
Treatment
n=56 Participants
The treatment group will receive dupilumab at 300mg SC Q2weeks. The first dose will be administered via subcutaneous injection in clinic at baseline. Subjects will self-administer study drug (dupilumab 300 mg) subcutaneous every 2 weeks after initial dosing at visit 2.
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|---|---|
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Change in Olfactory Cleft Endoscopy Score Based on Nasalendoscopy.
Baseline
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6.5 endoscopy score
Standard Deviation 3.3
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Change in Olfactory Cleft Endoscopy Score Based on Nasalendoscopy.
Week 12
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3.9 endoscopy score
Standard Deviation 3.0
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PRIMARY outcome
Timeframe: Baseline and Week 12 (3 months post-treatment)Olfactory cleft mucus samples were collected under endoscopic guidance at Baseline, Week 2, and Week 12. IL-13 concentrations were measured using a commercially available LegendPlex Th2 Cytometric Bead Array according to the manufacturer's instructions. The outcome reported here represents IL-13 concentration measured at Baseline and Week 12 to evaluate change after 3 months of dupilumab treatment.
Outcome measures
| Measure |
Treatment
n=28 Participants
The treatment group will receive dupilumab at 300mg SC Q2weeks. The first dose will be administered via subcutaneous injection in clinic at baseline. Subjects will self-administer study drug (dupilumab 300 mg) subcutaneous every 2 weeks after initial dosing at visit 2.
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|---|---|
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Change in Olfactory Cleft Mucus IL-13 Concentration
Baseline
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53.2 pg/mL
Standard Deviation 67.1
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Change in Olfactory Cleft Mucus IL-13 Concentration
Week 12
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95.1 pg/mL
Standard Deviation 164.9
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PRIMARY outcome
Timeframe: 3 months post-treatmentSubjects will have sinonasal endoscopy at baseline and every follow up visit. This procedure allows visual inspection of the sinus mucosal lining and grading of polyps, including the olfactory cleft. Results for each side will be recorded separately and combined for a final Lund-Kennedy endoscopy score (LKES) that ranges from 0-20, with higher scores representing increased disease severity.
Outcome measures
| Measure |
Treatment
n=57 Participants
The treatment group will receive dupilumab at 300mg SC Q2weeks. The first dose will be administered via subcutaneous injection in clinic at baseline. Subjects will self-administer study drug (dupilumab 300 mg) subcutaneous every 2 weeks after initial dosing at visit 2.
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|---|---|
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Change in Lund-Kennedy Endoscopy Score.
Baseline
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7.4 Lund-Kennedy Endoscopy Score
Standard Deviation 2.8
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Change in Lund-Kennedy Endoscopy Score.
Week 12
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4.5 Lund-Kennedy Endoscopy Score
Standard Deviation 2.9
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PRIMARY outcome
Timeframe: Baseline and Week 12 (3 months post-treatment)Overall Nasal Polyp Score (NPS) was assessed by sinonasal endoscopy. Polyps were graded separately in each nasal cavity on a scale from 0 to 4 and summed to calculate a total bilateral score ranging from 0 to 8. Higher scores indicate greater nasal polyp burden and more severe disease, while lower scores indicate less disease and improvement.
Outcome measures
| Measure |
Treatment
n=57 Participants
The treatment group will receive dupilumab at 300mg SC Q2weeks. The first dose will be administered via subcutaneous injection in clinic at baseline. Subjects will self-administer study drug (dupilumab 300 mg) subcutaneous every 2 weeks after initial dosing at visit 2.
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|---|---|
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Change in Overall Polyp Score From Sinonasal Endoscopy
Baseline
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3.5 Scores on a scale
Standard Deviation 1.8
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Change in Overall Polyp Score From Sinonasal Endoscopy
Week 12
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1.8 Scores on a scale
Standard Deviation 1.6
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SECONDARY outcome
Timeframe: Baseline and Week 12 (3 months post-treatment)Quantitative psychophysical olfactory testing was performed using the Sniffin' Sticks Test. This validated test assesses odor threshold (T), odor discrimination (D), and odor identification (I). Individual component scores are summed to generate a Total TDI Score that reflects overall olfactory function, with higher scores indicating better olfactory function. The correlation between olfactory cleft mucus IL-13 levels and change in Total TDI Score from Baseline to Week 12 was assessed using Spearman correlation.
Outcome measures
| Measure |
Treatment
n=28 Participants
The treatment group will receive dupilumab at 300mg SC Q2weeks. The first dose will be administered via subcutaneous injection in clinic at baseline. Subjects will self-administer study drug (dupilumab 300 mg) subcutaneous every 2 weeks after initial dosing at visit 2.
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|---|---|
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Correlation Between Change in Olfactory Cleft Mucus IL-13 Level and Sniffin' Sticks TDI Score
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.400 Correlation coefficient (Spearman rho)
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SECONDARY outcome
Timeframe: Baseline and Week 12 (3 months post-treatment)Olfactory-specific quality of life was assessed using the Questionnaire of Olfactory Disorders - Negative Statements (QOD-NS), a validated patient-reported outcome measure of olfactory-specific quality of life. The QOD-NS total score ranges from 0 to 51, with higher scores indicating better olfactory-specific quality of life and lower scores indicating greater olfactory-related impairment. The correlation between change in olfactory cleft mucus IL-13 level and change in QOD-NS score from Baseline to Week 12 was assessed using Spearman correlation.
Outcome measures
| Measure |
Treatment
n=27 Participants
The treatment group will receive dupilumab at 300mg SC Q2weeks. The first dose will be administered via subcutaneous injection in clinic at baseline. Subjects will self-administer study drug (dupilumab 300 mg) subcutaneous every 2 weeks after initial dosing at visit 2.
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|---|---|
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Correlation Between Change in IL13 Level and QOD-NS Score
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.331 Correlation coefficient (Spearman rho)
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Adverse Events
Dupilumab
Serious adverse events
| Measure |
Dupilumab
n=59 participants at risk
On Dupilumab
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
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1.7%
1/59 • From enrollment until end of follow-up, up to 12 weeks
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Other adverse events
| Measure |
Dupilumab
n=59 participants at risk
On Dupilumab
|
|---|---|
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Immune system disorders
covid-19
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3.4%
2/59 • From enrollment until end of follow-up, up to 12 weeks
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Skin and subcutaneous tissue disorders
Rash
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3.4%
2/59 • From enrollment until end of follow-up, up to 12 weeks
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General disorders
Headache
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5.1%
3/59 • From enrollment until end of follow-up, up to 12 weeks
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Infections and infestations
Sinus Infection
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1.7%
1/59 • From enrollment until end of follow-up, up to 12 weeks
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General disorders
Body aches
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3.4%
2/59 • From enrollment until end of follow-up, up to 12 weeks
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General disorders
Oral ulcer
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1.7%
1/59 • From enrollment until end of follow-up, up to 12 weeks
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Reproductive system and breast disorders
Ovarian Cyst
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1.7%
1/59 • From enrollment until end of follow-up, up to 12 weeks
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place