RecruitingPhase 3

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

Trevi Therapeutics · NCT07868419

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

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

Being studied: NAL ER; Placebo

Conditions: Idiopathic Pulmonary Fibrosis

Copied from the official record. The study team makes the final decision at screening.

Show full 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.