Brief Summary
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).
Brief Title
Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
(203) 304-2499
Central Contact Email
Paula.Buckley@trevitherapeutics.com
Completion Date
Completion Date Type
Estimated
Conditions
IDIOPATHIC PULMONARY FIBROSIS
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.
* 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.
* 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.
Inclusion 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.
* 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.
inclusion/
* 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.
inclusion/
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
40 Years
NCT Id
NCT07671911
Org Class
Industry
Org Full Name
Trevi Therapeutics
Org Study Id
NAL03-301
Overall Status
Recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Chronic Cough in Participants With Idiopathic Pulmonary Fibrosis
Primary Outcomes
Outcome Measure
Relative Change from Baseline in 24-hour Cough Frequency at Week 26
Outcome Time Frame
Baseline, Week 26
Secondary Ids
Secondary Id
2026-525877-38-00
Secondary Outcomes
Outcome Time Frame
Baseline, Week 26
Outcome Measure
Absolute Change from Baseline in the Cough Severity Numerical Rating Scale (CS-NRS) at Week 26
Outcome Time Frame
Baseline, Week 6
Outcome Measure
Relative Change from Baseline in 24-hour Cough Frequency at Week 6
Outcome Time Frame
Baseline, Week 26
Outcome Measure
Percentage of Participants Achieving ≥50% Reduction from Baseline in 24-hour Cough Frequency at Week 26
Outcome Time Frame
Baseline, Week 26
Outcome Measure
Absolute Change from Baseline in the Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E:RS-IPF) Cough Domain at Week 26
Outcome Time Frame
Baseline, Week 26
Outcome Measure
Percentage of Participants Achieving a ≥3-point Improvement from Baseline in CS-NRS at Week 26
Outcome Time Frame
Baseline, Week 26
Outcome Measure
Absolute Change from Baseline in the E:RS IPF Breathlessness Domain at Week 26
Outcome Time Frame
Baseline up to Week 54
Outcome Measure
Relative Change from Baseline in 24-hour Cough Frequency
Outcome Time Frame
Baseline up to Week 54
Outcome Measure
Absolute Change from Baseline in 24-hour Cough Frequency
Outcome Time Frame
Baseline up to Week 54
Outcome Measure
Percentage of Participants Achieving ≥30%, ≥50% and ≥75% Reduction from Baseline in 24-Hour Cough Frequency
Outcome Time Frame
Baseline up to Week 54
Outcome Measure
Absolute Change from Baseline in the E-RS:IPF Cough Domain
Outcome Time Frame
Baseline up to Week 54
Outcome Measure
Absolute Change from Baseline in the E-RS:IPF Total Score and Domain Scores (IPF-Breathlessness, IPF-Cough, IPF-Sputum, and IPF-Chest Symptoms)
Outcome Time Frame
Baseline up to Week 54
Outcome Measure
Absolute Change from Baseline in the CS-NRS
Outcome Time Frame
Baseline up to Week 54
Outcome Measure
Percentage of Participants Achieving a ≥3-Point Improvement from Baseline in CS-NRS
Outcome Time Frame
Baseline up to Week 54
Outcome Measure
Absolute Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Scores
Outcome Time Frame
Baseline up to Week 54
Outcome Measure
Percentage of Participants Achieving a 1.3-Point Increase (Improvement) from Baseline in LCQ Total Score
Outcome Time Frame
Baseline up to Week 54
Outcome Measure
Absolute Change from Baseline in Each LCQ Domain Score (Physical, Psychological, Social)
Outcome Time Frame
Baseline, Week 26
Outcome Measure
Change from Baseline in the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) at Week 26
Outcome Time Frame
Baseline up to Week 54
Outcome Measure
Relative Change from Baseline in Awake Cough Frequency
Outcome Time Frame
Baseline up to Week 54
Outcome Measure
Relative Change from Baseline in Sleep Cough Frequency
Outcome Time Frame
Baseline up to Week 54
Outcome Measure
Absolute Change from Baseline in the Patient Global Impression of Severity (PGI-S) Cough Score
Outcome Time Frame
Baseline up to Week 54
Outcome Measure
Absolute Change from Baseline in the Patient Global Impression of Change (PGI-C) Cough Score
Outcome Time Frame
Baseline up to Week 54
Outcome Measure
Percentage of Participants with Improvements by ≥1 and ≥2 Categories from Baseline on the PGI-S Cough
Outcome Time Frame
Up to Week 57
Outcome Measure
Safety and Tolerability as Assessed by Number of Participants with Treatment Emergent Adverse Events (TEAEs)
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
40
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ali Mansour
Investigator Email
amansour@montefiore.org
Investigator Sponsor Organization
Montefiore
Study Department
Medicine
Study Division
Critical Care Medicine
Categories Mesh Debug
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
MeSH Terms
IDIOPATHIC PULMONARY FIBROSIS
PULMONARY FIBROSIS
LUNG DISEASES, INTERSTITIAL
LUNG DISEASES
RESPIRATORY TRACT DISEASES
NALBUPHINE
MORPHINANS
OPIATE ALKALOIDS
ALKALOIDS
HETEROCYCLIC COMPOUNDS
HETEROCYCLIC COMPOUNDS, BRIDGED-RING
HETEROCYCLIC COMPOUNDS, 4 OR MORE RINGS
HETEROCYCLIC COMPOUNDS, FUSED-RING
PHENANTHRENES
POLYCYCLIC AROMATIC HYDROCARBONS
POLYCYCLIC COMPOUNDS