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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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

Key facts

Study ID

NCT07671911

Run by

Trevi Therapeutics

People needed

306

Starts

2026-06-29

Expected to finish

2028-07-01

Last updated by the study team

2026-07-10

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Participants who are currently taking antifibrotic medication (e.g., nintedanib, pirfenidone, nerandomilast) should be on a stable dose for at least 6 weeks prior to the Baseline Visit.

You may not qualify if…

• 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 2 months prior to Screening.
• Diagnosed sleep apnea or currently on any treatment for sleep apnea [example (e.g.), Continuous Positive Airway Pressure (CPAP)].
• Note: Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Pulmonary Specialists of The Palm Beaches — Loxahatchee Groves, Florida, United States (enrolling)
• Clinical Research and Associates, Inc. — Miami, Florida, United States (enrolling)
• Clinical Research of Gastonia (CRG) — Gastonia, North Carolina, United States (enrolling)
• El Paso Pulmonary Association, PA — El Paso, Texas, United States (enrolling)
• Elevate Clinical Research — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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