Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Mechanisms of Smell Improvement With Dupilumab

ID
Name
Pro00125142
Description
This study seeks to explore the mechanism through which dupilumab improves olfactory cleft inflammation in patients with chronic sinusitis with nasal polyps (CRSwNP). The investigators expect this study to provide convincing evidence that dupilumab improves clinical olfaction via direct reduction in olfactory cleft inflammation.
Trial arms
Trial start
2023-08-10
Estimated PCD
2025-06-30
Trial end
2025-06-30
Status
Recruiting
Phase
Early phase I
Treatment
Dupilumab
Monoclonal antibody blocking interleukin 4 and interleukin 13
Arms:
Treatment
Size
50
Primary endpoint
Change in volumetric olfactory cleft opacification based on CT.
3 months post-treatment
Change in olfactory cleft endoscopy score based on nasalendoscopy.
3 months post-treatment
Change in olfactory cleft mucus cytokine levels
3 months post-treatment
Change in Lund-Kennedy endoscopy score.
3 months post-treatment
Change in overall polyp score from sinonasal endoscopy
3 months post-treatment.
Eligibility criteria
Inclusion Criteria: * Adults ≥18 years of age * Meet criteria for CRSwNP as defined by ICAR-21 * 2 out of 4 cardinal symptoms for ≥12 weeks * Visible evidence of inflammation on endoscopy or imaging * Bilateral visible nasal polyps ≥1 in each nasal cavity (0-4 scale each side) * Olfaction score ≥1 (0-3 scale) * Candidate for treatment with dupilumab for CRSwNP * Elected to proceed with dupilumab for treatment of CRSwNP Exclusion Criteria: * Prior use of dupilumab * Previous treatment with another biologic medication for CRSwNP or asthma within 6 months * Any nasal or sinus surgery within the last 3 months * Oral corticosteroid use within the last 1 month * Current pregnancy, breast-feeding, or plan to become pregnant during next 3 months * Presence of antrochoanal nasal polyps; acute rhinosinusitis; upper respiratory infection; * Allergic granulomatous angiitis/eosinophilic granulomatosis with polyangiitis; * Granulomatosis with polyangiitis; cystic fibrosis; Young syndrome; * Kartagener syndrome; or dyskinetic cilia syndrome * Poorly controlled asthma
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2023-09-08

1 organization

1 product

1 indication

Organization
Medical University of South Carolina
Product
Dupilumab
Indication
Chronic Rhinosinusitis