NCT07671911

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
306

participants targeted

Target at P50-P75 for phase_3

Timeline
23mo left

Started Jun 2026

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Jun 2026Jul 2028

First Submitted

Initial submission to the registry

June 22, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

June 29, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

1.9 years

First QC Date

June 22, 2026

Last Update Submit

July 9, 2026

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

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

    Baseline, Week 26

Secondary Outcomes (22)

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

    Baseline, Week 26

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

    Baseline, Week 6

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

    Baseline, Week 26

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

    Baseline, Week 26

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

    Baseline, Week 26

  • +17 more secondary outcomes

Study Arms (2)

NAL ER 54 mg

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

NAL ERDRUG

Oral tablets

Also known as: Nalbuphine
NAL ER 54 mg
PlaceboDRUG

Oral tablets

Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 \[example (e.g.), Continuous Positive Airway Pressure (CPAP)\].

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pulmonary Specialists of The Palm Beaches

Loxahatchee Groves, Florida, 33470, United States

RECRUITING

Clinical Research and Associates, Inc.

Miami, Florida, 33126, United States

RECRUITING

Clinical Research of Gastonia (CRG)

Gastonia, North Carolina, 28054, United States

RECRUITING

El Paso Pulmonary Association, PA

El Paso, Texas, 79902, United States

RECRUITING

Elevate Clinical Research

Houston, Texas, 77058, United States

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Nalbuphine

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Chief Development Officer

    Trevi Therapeutics

    STUDY DIRECTOR

Central Study Contacts

Paula Buckley

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2026

First Posted

June 26, 2026

Study Start

June 29, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(5)