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

NCT05185089 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: ORV-PF-01
• Study Type: interventional
• Target: 80
• Locations: 3 countries
• Sites: 37

Brief 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.

Conditions

Cough; Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Weekly Average of the Daily Idiopathic Pulmonary Fibrosis Coughing Severity Scale (IPF CSS)

  A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine) for coughing severity in the last 24 hours

  Week 4

Secondary Outcomes (14)

• Mean Change From Baseline in Weekly Average of the Early Morning IPF Coughing Severity Scale

  Week 4

• Mean Change From Baseline in Weekly Average of the Rest of the Day IPF Coughing Severity Scale

  Week 4

• Mean Change From Baseline in Weekly Average of the Daily Urge to Cough Scale

  Week 4

• Mean Change From Baseline in Weekly Average of the Daily Cough Frequency Scale

  Week 4

• Mean Change From Baseline in Weekly Average of the Daily Dyspnoea Scale

  Week 4

Study Arms (3)

Orvepitant 30mg

EXPERIMENTAL

Orvepitant 30mg tablet once daily for 4 weeks

Drug: Orvepitant Maleate

Orvepitant 10mg

EXPERIMENTAL

Orvepitant 10mg tablet once daily for 4 weeks

Drug: Orvepitant Maleate

Placebo

PLACEBO COMPARATOR

Placebo tablet once daily for 4 weeks

Drug: Placebo

Interventions

Orvepitant Maleate DRUG

Orvepitant tablets 30mg or 10mg

Orvepitant 10mg; Orvepitant 30mg

Placebo DRUG

Placebo tablets to match orvepitant 30mg and 10mg tablets

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of IPF established according to the 2018 or 2022 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 (after rounding) during the second week of the baseline assessment period

You may not qualify if:

• 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 and rest of the day cough scale score \<5 (after rounding) 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

Sponsors & Collaborators

• Nerre Therapeutics Ltd.: lead
• Pharm-Olam International: collaborator

Study Sites (37)

University of Southern California

Los Angeles, California, 90033, United States

Location

University of California

San Francisco, California, 94143, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Loyola University Chicago

Maywood, Illinois, 60153, United States

Location

Jadestone Clinical Research, LLC

Silver Spring, Maryland, 20904, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

American Health Research

Charlotte, North Carolina, 28277, United States

Location

PulmonIx, LLC

Greensboro, North Carolina, 27403, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29424, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37204, United States

Location

Baylor University

Dallas, Texas, 75246, United States

Location

Clear Lake Health

Webster, Texas, 77598, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Zuyderland Medical Centre

Heerlen, 6419 PC, Netherlands

Location

Sint Antonius Hospital

Nieuwegein, 3435 CM, Netherlands

Location

Erasmus University Medical Centre

Rotterdam, 3015 GD, Netherlands

Location

Isala Ziekenhuis

Zwolle, 8025 AB, Netherlands

Location

Royal Berkshire Hospital

Reading, Berkshire, RG1 5AN, United Kingdom

Location

Castle Hill Hospital

Cottingham, Hull, HU16 5JQ, United Kingdom

Location

MAC Clinical Research

Prescot, Merseyside, L34 1BH, United Kingdom

Location

Antrim Area Hospital

Antrim, Northern Ireland, BT41 2RL, United Kingdom

Location

Altnagelvin Area Hospital

Londonderry, Northern Ireland, BT47 6SB, United Kingdom

Location

Churchill Hospital

Headington, Oxford, OX3 7LE, United Kingdom

Location

Perth Royal Infirmary

Perth, Perth and Kinross, PH1 1NX, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16 4SA, United Kingdom

Location

MAC Clinical Research

Barnsley, South Yorkshire, S75 3DL, United Kingdom

Location

MAC Clinical Research

Leeds, West Yorkshire, LS10 1DU, United Kingdom

Location

Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

Royal Papworth Hospital

Cambridge, CB2 0AY, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, EX2 5DW, United Kingdom

Location

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

MAC Clinical Research

Manchester, M13 9NQ, United Kingdom

Location

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Cough; Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases

Limitations and Caveats

Interpretation of the pre-specified efficacy analyses was confounded by a significant treatment by period interaction. This appeared related to a marked placebo response in the first (but not second) treatment period.

Results Point of Contact

• Title: CMO
• Organization: NeRRe Therapeutics Ltd

info@nerretherapeutics.com

+44 (0)1438 906960

Study Officials

• Prof. S. Birring, MB ChB, MD

  Department of Respiratory Medicine, King's College Hospital, London UK

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 11, 2022
• Study Start: August 1, 2022
• Primary Completion: June 5, 2024
• Study Completion: June 19, 2024
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (17); US (16); NL (4)