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

NCT03681093 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2021-10-11

Study results available
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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.

Conditions

  • Nasal Polyps

Interventions

DRUG

Fevipiprant 150 mg

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

DRUG

Fevipiprant 450 mg

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

DRUG

Placebo

Placebo once daily administered orally as tablet

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-26
Primary Completion
2020-05-29
Completion
2020-06-10
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Canada
  • Czechia
  • Germany
  • Italy
  • Netherlands
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03681093 on ClinicalTrials.gov