NCT07868419

Brief Summary

The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with IPF.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P25-P50 for phase_3

Timeline
12mo left

Started Sep 2026

Shorter than P25 for phase_3

Geographic Reach
1 country

4 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 Progress3%
Sep 2026Oct 2027

Study Start

First participant enrolled

September 30, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

10 months

First QC Date

October 5, 2026

Last Update Submit

October 5, 2026

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Relative Change from Baseline in 24-hour Cough Frequency at Week 14 for NAL ER Compared With Placebo

    Baseline, Week 14

Secondary Outcomes (19)

  • Absolute Change from Baseline in the Cough Severity Numerical Rating Scale (CS-NRS) at Week 14 for NAL ER Compared With Placebo

    Baseline, Week 14

  • Relative Change from Baseline in 24-hour Cough Frequency for NAL ER Compared With Placebo

    Baseline, Weeks 6 and 10

  • Absolute Change from Baseline in 24-hour Cough Frequency for NAL ER Compared With Placebo

    Baseline, Weeks 6 and 10

  • Proportion of Participants Achieving ≥30%, ≥50% and ≥75% Reduction from Baseline in 24-hour Cough Frequency at Week 14 for NAL ER Compared With Placebo

    Baseline, Week 14

  • Absolute Change from Baseline in the Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E:RS-IPF) Cough Domain at Week 14 for NAL ER Compared With Placebo

    Baseline, Week 14

  • +14 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 12 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 12 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.
  • If currently taking antifibrotic medication (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 8 weeks prior to Screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Premier Medical Associates, LLC

Wilmington, Delaware, 19803, United States

RECRUITING

Essential Health and Research Services

North Miami Beach, Florida, 33162, United States

RECRUITING

American Health Research - Charlotte Location

Charlotte, North Carolina, 28277, United States

RECRUITING

Hillcroft Medical Clinic

Sugar Land, Texas, 77478, 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, Inc.

    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

October 5, 2026

First Posted

October 9, 2026

Study Start

September 30, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations

US(4)