Phase 2 Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With IPF

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nerre Therapeutics Ltd.
• Collaborator: Pharm-Olam International
• Treatments: Maleic acid

Criteria

Key Inclusion Criteria:

• Diagnosis of IPF established according to the 2018 joint ATS/ERS/JRS/ALAT Clinical Practice Guideline

• FEV1/FVC ratio ≥0.65 at the screening visit

• Haemoglobin-corrected diffusion capacity of carbon monoxide (Hb-corrected DLCO) ≥25% within 12 months of the screening visit

• Arterial oxygen saturation on room air or oxygen ≥90% at Screening

• Life expectancy of at least 12 months

• Cough that is attributed to IPF, which has not responded to anti-tussive treatment, and which has been present for at least 8 weeks prior to Screening

• Mean daily IPF Coughing Severity Scale score ≥5.0 during the second week of the baseline assessment period

Key Exclusion Criteria:

• Recent respiratory tract infection (<8 weeks prior to Screening)

• Recent acute exacerbation of IPF (<8 weeks prior to Screening)

• Current smokers or ex-smokers with <6 months' abstinence prior to Screening

• Emphysema ≥50% on high-resolution computed tomography, or the extent of emphysema is greater than the extent of fibrosis according to the reported results of the most recent scan

• Mean early morning cough scale score ≥5.0 and rest of the day cough scale score <5 during the second week of the baseline assessment period (assessed at Visit 2)

• Cough that is predominantly productive in nature and attributable to lung pathology such as chronic bronchitis or bronchiectasis