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

Purpose

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).

Condition

  • Idiopathic Pulmonary Fibrosis

Eligibility

Eligible Ages
Over 40 Years
Eligible Sex
All
Accepts 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. - 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.

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. - 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
NAL ER 54 mg 		Participants will undergo a 2-week blinded titration period followed by a fixed dose treatment period receiving NAL ER 54 milligrams (mg) twice daily (BID) for 52 weeks.
  • Drug: NAL ER
    Oral tablets
    Other names:
    • Nalbuphine
Placebo Comparator
Placebo 		Participants will undergo a 2-week blinded titration period followed by a fixed dose treatment period receiving a matching placebo BID for 52 weeks.
  • Drug: Placebo
    Oral tablets

Recruiting Locations

Pulmonary Specialists of The Palm Beaches
Loxahatchee Groves, Florida 33470

Clinical Research and Associates, Inc.
Miami, Florida 33126

Clinical Research of Gastonia (CRG)
Gastonia, North Carolina 28054

El Paso Pulmonary Association, PA
El Paso, Texas 79902

Elevate Clinical Research
Houston, Texas 77058

More Details

Status
Recruiting
Sponsor
Trevi Therapeutics

Study Contact

Paula Buckley
(203) 304-2499
Paula.Buckley@trevitherapeutics.com