NCT05185089

Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis

A Double-Blind, Randomised, Placebo Controlled, Two Period Cross-Over Study to Evaluate the Efficacy and Safety of Orvepitant in Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Nerre Therapeutics Ltd. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

ORV-PF-01 is a two way, placebo controlled, cross-over study, to evaluate the effect of two doses of orvepitant on cough in patients with IPF.

Detailed description

The study will be a multi-center, double-blind, randomised, placebo-controlled 2-period cross-over study in subjects with chronic cough due to idiopathic pulmonary fibrosis (IPF). Subjects will participate in one of two cohorts (Cohort 1 and Cohort 2). Cohort 1 will evaluate a 30 mg orvepitant dose and Cohort 2 the 10 mg dose. Within each cohort, subjects will be randomised to receive either orvepitant or placebo in the first treatment period (Treatment Period A) followed by the alternate treatment in Treatment Period B. There will be a wash-out period of 3 weeks between the two treatment periods. Subjects will be randomised 1:1 to each of the two treatment orders and 1:1 to each cohort. Subjects will enter a screening period of between 14 and 28 days to determine eligibility. Eligible subjects will be randomised at the Baseline visit and will participate in two identical 28 day treatment periods with the wash-out period between them. There will be a total of 8 visits including the Screening, Baseline and final Follow-up visits.

Conditions

• Cough
• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Orvepitant Maleate	Orvepitant tablets 30mg or 10mg
DRUG	Placebo	Placebo tablets to match orvepitant 30mg and 10mg tablets

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-06-05
• Completion: 2024-06-19
• First posted: 2022-01-11
• Last updated: 2025-11-10
• Results posted: 2025-11-10

Locations

37 sites across 3 countries: United States, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study