About the study

A Phase 3b Proof-of-Concept study to evaluate the ability of fevipiprant dose 1 and dose 2, compared with placebo, as add-on to nasal spray standard-of-care (SoC), in reducing endoscopic nasal polyp score in adult (≥ 18 years) patients with nasal polyposis and concomitant asthma.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Patients aged 18 years or more with a diagnosis of nasal polyps with Nasal polyp score >= 4 with minimum score of 2 in each nostril.
2. Concomitant diagnosis of asthma for a period of at least 6 months prior to screening.
3. Patients on stable asthma treatment of at least inhaled corticosteroids (any dose) alone for at least 6 months prior to screening or ICS for 6 months prior to screening with any required, inhaled medication (LABA, LAMA) added at least 6 weeks prior to screening.

Exclusion criteria

1. Asthma exacerbation, within 6 weeks prior to screening, that required systemic corticosteroids, hospitalization or emergency room visit.
2. Chronic/maintenance use of oral corticosteroids (OCS) defined as any continuous use of OCS for a period of 1 month or more, within 1 year of screening
3. Use of biologics for asthma or any other indications, that has the potential to interfere/affect either asthma or nasal polyposis disease progression, within 6 months of screening.
4. Use of medication for sino-nasal symptoms (antibiotics with or without OCS) within 30 days of screening or during the run-in period.
5. Use of tetracycline or macrolide antibiotics specifically, within 8 weeks of screening.
6. History of nasal surgery modifying the structure of the nose such that assessment of the nasal polyp score is not possible.
7. Patients with baseline ACQ-5≥1.5

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.