CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 98 enrolled
Drug / intervention
Fevipiprant 150 mg +2 moredrug
Likely dose
Fevipiprant 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03681093
NCT03681093Phase 3Completed

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Fevipiprant Once Daily Plus Standard-of-care (SoC) for Assessment of the Efficacy in Reduction of Nasal Polyp Size in Patients With Nasal Polyposis and Concomitant Asthma.

Novartis Pharmaceuticals·interventional·Posted Sep 21, 2018·Updated Oct 11, 2021

In Brief

A Phase 3 clinical trial evaluating Fevipiprant 150 mg, Fevipiprant 450 mg, and 1 other intervention for Nasal Polyps. Completed, enrolled 98 participants across 25 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasal Polyps
CountriesArgentina, Belgium, Canada, Czechia, Germany, Italy, Netherlands, Poland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedSep 21, 2018
Enrollment StartMar 26, 2019
Primary CompletionMay 29, 2020
Study CompletionJun 10, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.8 years ago

Interventions

Fevipiprant 150 mgdrug

Fevipiprant (QAW039) 150 mg once daily administered orally as tablet

Fevipiprant 450 mgdrug

Fevipiprant (QAW039) 450 mg once daily administered orally as tablet

Placebodrug

Placebo once daily administered orally as tablet