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

RecruitingPhase 3

A Randomized, Double-Blind, Placebo-Controlled Twelve-Week Fixed-Dose Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Chronic Cough in Participants With Idiopathic Pulmonary Fibrosis

Who can join

Ages 40 and older · All sexes

Full eligibility criteria
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.

About the study

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

What is being tested

Sponsor: Trevi Therapeutics · Participants: 201 · Started: Sep 30, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07868419

Locations in the U.S.

AlabamaSec Clinical Research - Dothan, Tuscaloosa
ConnecticutStarling Physicians, P.C., New Britain
DelawarePremier Medical Associates, LLC, Wilmington
FloridaD&H Doral Research Center, Doral
Blessed Health Care and Research Inc., Miami
Coral Research Clinic Corp., Miami
Pharma Medical Innovations, Inc., Miami Lakes
Essential Health and Research Services, North Miami Beach
MarylandVelocity Clinical Research - Rockville, Rockville
MichiganVitalis Clinical Research Center LLC, Allen Park
MissouriVeritas Clinical Research, Warren
North CarolinaAmerican Health Research - Charlotte Location, Charlotte
OregonSummit Health (Summit Medical Group) - Eastside Clinic, Bend
The Oregon Clinic - Gateway Medical Office Location - Pulmonary, Critical Care & Sleep Medicine East, Portland
TexasStryde Research, Carrollton
Hillcroft Medical Clinic, Sugar Land

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.