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

Phase 3RecruitingNCT07671911

Trevi Therapeutics306 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

306

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

NAL ERDRUG

Oral tablets

PlaceboDRUG

Oral tablets

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (19)

Newportnativemd, Inc.

Newport Beach, California, United States

Outcomes

Primary Outcomes

Relative Change from Baseline in 24-hour Cough Frequency at Week 26

Time frame: Baseline, Week 26

Secondary Outcomes

Absolute Change from Baseline in the Cough Severity Numerical Rating Scale (CS-NRS) at Week 26

Time frame: Baseline, Week 26

Relative Change from Baseline in 24-hour Cough Frequency at Week 6

Time frame: Baseline, Week 6

Percentage of Participants Achieving ≥50% Reduction from Baseline in 24-hour Cough Frequency at Week 26

Time frame: Baseline, Week 26

Absolute Change from Baseline in the Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E:RS-IPF) Cough Domain at Week 26

Time frame: Baseline, Week 26

Percentage of Participants Achieving a ≥3-point Improvement from Baseline in CS-NRS at Week 26

Time frame: Baseline, Week 26

Absolute Change from Baseline in the E:RS IPF Breathlessness Domain at Week 26

Time frame: Baseline, Week 26

Relative Change from Baseline in 24-hour Cough Frequency

Time frame: Baseline up to Week 54

Absolute Change from Baseline in 24-hour Cough Frequency

Time frame: Baseline up to Week 54

Percentage of Participants Achieving ≥30%, ≥50% and ≥75% Reduction from Baseline in 24-Hour Cough Frequency

Time frame: Baseline up to Week 54

Central Contacts

Paula Buckley

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Palmtree Clinical Research

Palm Springs, California, United States

RECRUITING

Paradigm Clinical Research Centers, Inc. - Redding

Redding, California, United States

RECRUITING

Critical Care Pulmonary and Sleep Associates (Ccpsa) - West Clinic

Lakewood, Colorado, United States

RECRUITING

Meris Clinical Research

Brandon, Florida, United States

RECRUITING

Clinical Research Specialists, Llc - Kissimmee

Kissimmee, Florida, United States

RECRUITING

Pulmonary Specialists of The Palm Beaches

Loxahatchee Groves, Florida, United States

RECRUITING

Clinical Research and Associates, Inc.

Miami, Florida, United States

RECRUITING

Coastal Pulmonary & Critical Care, PLC

St. Petersburg, Florida, United States

RECRUITING

Tulane Clinic

New Orleans, Louisiana, United States

RECRUITING

...and 9 more locations

Absolute Change from Baseline in the E-RS:IPF Cough Domain

Time frame: Baseline up to Week 54

Absolute Change from Baseline in the E-RS:IPF Total Score and Domain Scores (IPF-Breathlessness, IPF-Cough, IPF-Sputum, and IPF-Chest Symptoms)

Time frame: Baseline up to Week 54

Absolute Change from Baseline in the CS-NRS

Time frame: Baseline up to Week 54

Percentage of Participants Achieving a ≥3-Point Improvement from Baseline in CS-NRS

Time frame: Baseline up to Week 54

Absolute Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Scores

Time frame: Baseline up to Week 54

Percentage of Participants Achieving a 1.3-Point Increase (Improvement) from Baseline in LCQ Total Score

Time frame: Baseline up to Week 54

Absolute Change from Baseline in Each LCQ Domain Score (Physical, Psychological, Social)

Time frame: Baseline up to Week 54

Change from Baseline in the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) at Week 26

Time frame: Baseline, Week 26

Relative Change from Baseline in Awake Cough Frequency

Time frame: Baseline up to Week 54

Relative Change from Baseline in Sleep Cough Frequency

Time frame: Baseline up to Week 54

Absolute Change from Baseline in the Patient Global Impression of Severity (PGI-S) Cough Score

Time frame: Baseline up to Week 54

Absolute Change from Baseline in the Patient Global Impression of Change (PGI-C) Cough Score

Time frame: Baseline up to Week 54

Percentage of Participants with Improvements by ≥1 and ≥2 Categories from Baseline on the PGI-S Cough

Time frame: Baseline up to Week 54

Safety and Tolerability as Assessed by Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Time frame: Up to Week 57