Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma

Summary

A Phase 3b Proof-of-Concept study to evaluate the ability of fevipiprant 150 mg and 450 mg, 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.

Timeline

Start

2019-03-26

Primary completion

2020-05-29

Completion

2020-06-10

Outcome

Missed primary endpoint

registry analysis (superiority test); Fevipiprant 150 mg vs Placebo; p = 0.979 NCT03681093 ↗

registry analysis (superiority test); Fevipiprant 450 mg vs Placebo; p = 0.656 NCT03681093 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	fevipiprant	Small molecule	150 mg	Oral
Subject	fevipiprant	Small molecule	450 mg	Oral

Indications