Ireland
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Recruiting Phase 3

Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine (NAL) Extended-Release (ER) Tablets

NCT07868419 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2026-09-30
Last updated
2026-10-09

Condition(s) studied

Idiopathic Pulmonary Fibrosis

Investigational drug(s) / intervention(s)

NAL ER →Placebo

NAL ER: Oral tablets

Placebo: Oral tablets

Study summary

The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with IPF.

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of IPF as determined by the Investigator based on American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) clinical practice guidelines. * Chronic cough for ≥8 weeks prior to Screening. * PGI-Severity Score ≥ 2 at Screening. * Forced vital capacity (FVC) ≥40 percent (%) of predicted at Screening. * Diffusing capacity for carbon monoxide (DLCO) ≥25% of predicted during Screening or within 12 weeks prior to Screening. * If currently taking antifibrotic medication (nintedanib, pirfenidone, nerandomilast) should be on a stable dose for at least 6 weeks prior to the Baseline Visit. Exclusion Criteria: * Clinical diagnosis or clinical suspicion of an upper or lower respiratory tract infection in the last 8 weeks prior to the Screening visit or during Screening. * Hospitalization for any respiratory illness (including acute exacerbation of IPF) within 8 weeks prior to Screening. Note: Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcome measure(s)

  • Relative Change from Baseline in 24-hour Cough Frequency at Week 14 for NAL ER Compared With Placebo — Baseline, Week 14

Trial sites (4)

FacilityCityRegionStatus
Premier Medical Associates, LLC Wilmington Delaware Recruiting
Essential Health and Research Services North Miami Beach Florida Recruiting
American Health Research - Charlotte Location Charlotte North Carolina Recruiting
Hillcroft Medical Clinic Sugar Land Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07868419 on ClinicalTrials.gov ↗ ← All trials in the USA