Early-onset Dupilumab Effects in CRSwNP

• Status: Withdrawn
• Trial end date: 2027-06-01
• Target enrollment: 0
• Participant gender: All

Summary

While it is known that Dupilumab has profound effects in patients with CRSwNP, these are often seen months later after treatment initiation; however, in practice, patients often endorse feeling significantly better within days of their first injection. No studies have investigated the molecular basis for such an acute change. This study proposes that specific cytokine changes in phenotype in addition to microbiome and oscillometry effects play a synergistic role in producing this effect.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester

Criteria

Inclusion Criteria:

• Patients age 18+

• who in normal clinical practice would be a candidate for dupilumab.

• with a diagnosis of CRSwNP including

• at least 2 of the following symptoms on screening:

• nasal blockade/obstruction/congestion or nasal discharge;

• facial pain/pressure;

• reduction or loss of smell

Exclusion Criteria:

• > 80 years of age

• prior history of immunotherapy use (including prior participation in dupilumab or other clinical trials)

• Treatment with systemic corticosteroids, monoclonal antibodies, immunosuppressive treatments or anti-IgE therapy during the past two months prior to trial participation.

• CRS without polyps or another non-nasal polyposis condition

• Patients with conditions/concomitant diseases making them ineligible for evaluation of the primary efficacy endpoint such as: acute sinusitis/nasal infection or upper respiratory infection at day of screening or in the two weeks prior to screening, Churg-Strauss syndrome, Young's syndrome, Kartagener's syndrome or dyskinetic ciliary syndromes, concomitant cystic fibrosis, CT scan suggestive of allergic fungal rhinosinusitis

• Patients with comorbid asthma if they had a recent asthma exacerbation requiring systemic (oral and/or parenteral) steroid treatment or hospitalization for >24h for treatment of asthma, within 3 months prior to screening or are on a dose of greater than 1000 ug fluticasone or an equivalent inhaled corticosteroid.