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

Completed · Phase 3 · Has a placebo group

Conditions studied: Nasal Polyps

In brief

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.

Key facts

Study ID

NCT03681093

Run by

Novartis Pharmaceuticals

People needed

98

Starts

2019-03-26

Expected to finish

2020-06-10

Last updated by the study team

2021-10-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Concomitant diagnosis of asthma for a period of at least 6 months prior to screening.
• 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.

You may not qualify if…

• Asthma exacerbation, within 6 weeks prior to screening, that required systemic corticosteroids, hospitalization or emergency room visit.
• 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
• 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.
• Use of medication for sino-nasal symptoms (antibiotics with or without OCS) within 30 days of screening or during the run-in period.
• Use of tetracycline or macrolide antibiotics specifically, within 8 weeks of screening.
• History of nasal surgery modifying the structure of the nose such that assessment of the nasal polyp score is not possible.
• Patients with baseline ACQ-5≥1.5

Where it is running

• Novartis Investigative Site — Irvine, California, United States
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — Florida, Buenos Aires, Argentina
• Novartis Investigative Site — Rosario, Santa Fe Province, Argentina
• Novartis Investigative Site — San Miguel de Tucumán, Tucumán Province, Argentina
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Mendoza, Argentina
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Erpent, Belgium
• Novartis Investigative Site — Ottawa, Ontario, Canada
• Novartis Investigative Site — Québec, Canada
• Novartis Investigative Site — Olomouc, Czech Republic, Czechia
• Novartis Investigative Site — Svitavy, Czech Republic, Czechia
• Novartis Investigative Site — Kladno, Czechia
• Novartis Investigative Site — Dresden, Germany
• Novartis Investigative Site — Frankfurt, Germany
• Novartis Investigative Site — Rozzano, MI, Italy
• Novartis Investigative Site — Pisa, PI, Italy
• Novartis Investigative Site — Roma, RM, Italy
• Novartis Investigative Site — Amsterdam, Netherlands
• Novartis Investigative Site — Enschede, Netherlands
• Novartis Investigative Site — Strzelce Opolskie, Poland
• Novartis Investigative Site — Zawadzkie, Poland

Full record on ClinicalTrials.gov

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