Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets (OCEAN-1)

Trevi Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: NAL ER; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07671911

NAL03-301

2026-525877-38-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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).

Enrollment: 306 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.
• Participants who are currently taking antifibrotic medication (nintedanib, pirfenidone, nerandomilast) approved for IPF 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 2 months prior to Screening.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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306 participants in 2 patient groups, including a placebo group

NAL ER 54 mg

Experimental group

Description:

Participants will undergo a 2-week blinded titration period (twice daily \[BID\] dosing with one NAL ER once daily \[QD\] dose and one placebo QD dose) followed by a fixed dose treatment period receiving NAL ER 54 milligrams (mg) BID for 52 weeks.

Treatment:

Drug: Placebo

Drug: NAL ER

Placebo

Placebo Comparator group

Description:

Participants will undergo a 2-week blinded titration period followed by a fixed dose treatment period receiving a matching placebo BID for 52 weeks.

Treatment:

Drug: Placebo