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Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine (NAL) Extended-Release (ER) Tablets (OCEAN-2)

12. november 2026 opdateret af: Trevi Therapeutics

A Randomized, Double-Blind, Placebo-Controlled Twelve-Week Fixed-Dose Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Chronic Cough in Participants With Idiopathic Pulmonary Fibrosis

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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

201

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Alabama
      • Tuscaloosa, Alabama, Forenede Stater, 35476
        • Rekruttering
        • Sec Clinical Research - Dothan
    • Connecticut
      • New Britain, Connecticut, Forenede Stater, 06051
        • Rekruttering
        • Starling Physicians, P.C.
    • Delaware
      • Wilmington, Delaware, Forenede Stater, 19803
        • Rekruttering
        • Premier Medical Associates, LLC
    • Florida
      • Doral, Florida, Forenede Stater, 33122
        • Rekruttering
        • D&H Doral Research Center
      • Miami, Florida, Forenede Stater, 33186
        • Rekruttering
        • Coral Research Clinic Corp.
      • Miami, Florida, Forenede Stater, 33173
        • Rekruttering
        • Blessed Health Care and Research Inc.
      • Miami Lakes, Florida, Forenede Stater, 33016
        • Rekruttering
        • Pharma Medical Innovations, Inc.
      • North Miami Beach, Florida, Forenede Stater, 33162
        • Rekruttering
        • Essential Health and Research Services
    • Maryland
      • Rockville, Maryland, Forenede Stater, 20854
        • Rekruttering
        • Velocity Clinical Research - Rockville
    • Michigan
      • Allen Park, Michigan, Forenede Stater, 48101
        • Rekruttering
        • Vitalis Clinical Research Center LLC
    • Missouri
      • Warren, Missouri, Forenede Stater, 48071
        • Rekruttering
        • Veritas Clinical Research
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28277
        • Rekruttering
        • American Health Research - Charlotte Location
    • Oregon
      • Bend, Oregon, Forenede Stater, 97701
        • Rekruttering
        • Summit Health (Summit Medical Group) - Eastside Clinic
      • Portland, Oregon, Forenede Stater, 97220
        • Rekruttering
        • The Oregon Clinic - Gateway Medical Office Location - Pulmonary, Critical Care & Sleep Medicine East
    • Texas
      • Carrollton, Texas, Forenede Stater, 75010
        • Rekruttering
        • Stryde Research
      • Sugar Land, Texas, Forenede Stater, 77478
        • Rekruttering
        • Hillcroft Medical Clinic

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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 12 weeks.
Medicin: NAL ER

Oral tablets

Andre navne:
  • Nalbufin
Placebo komparator: Placebo

Participants will undergo a 2-week blinded titration period followed by a fixed dose treatment period receiving a matching placebo BID for 12 weeks.
Medicin: Placebo

Oral tablets

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Relative Change from Baseline in 24-hour Cough Frequency at Week 14 for NAL ER Compared With Placebo
Tidsramme: Baseline, Week 14
Baseline, Week 14

Sekundære resultatmål

Resultatmål
Tidsramme
Absolute Change from Baseline in the Cough Severity Numerical Rating Scale (CS-NRS) at Week 14 for NAL ER Compared With Placebo
Tidsramme: Baseline, Week 14
Baseline, Week 14
Relative Change from Baseline in 24-hour Cough Frequency for NAL ER Compared With Placebo
Tidsramme: Baseline, Weeks 6 and 10
Baseline, Weeks 6 and 10
Absolute Change from Baseline in 24-hour Cough Frequency for NAL ER Compared With Placebo
Tidsramme: Baseline, Weeks 6 and 10
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
Tidsramme: Baseline, Week 14
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
Tidsramme: Baseline, Week 14
Baseline, Week 14
Absolute Change from Baseline in the E-RS:IPF Total Score and Domain Scores (IPF-Breathlessness, IPF-Cough, IPF-Sputum, and IPF-Chest Symptoms) at Week 14 for NAL ER Compared With Placebo
Tidsramme: Baseline, Week 14
Baseline, Week 14
Absolute Change from Baseline in the CS-NRS for NAL ER Compared With Placebo
Tidsramme: Baseline up to Week 14
Baseline up to Week 14
Proportion of Participants Achieving a ≥3-point Improvement from Baseline in CS-NRS for NAL ER Compared With Placebo
Tidsramme: Baseline up to Week 14
Baseline up to Week 14
Absolute Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Scores at Week 14 for NAL ER Compared With Placebo
Tidsramme: Baseline, Week 14
Baseline, Week 14
Absolute Change from Baseline in Each LCQ Domain Score (Physical, Psychological, Social) at Week 14 for NAL ER Compared With Placebo
Tidsramme: Baseline, Week 14
Baseline, Week 14
Proportion of Participants Achieving a 1.3-point Increase (Improvement) from Baseline in LCQ Total Score at Week 14 for NAL ER Compared With Placebo
Tidsramme: Baseline, Week 14
Baseline, Week 14
Change from Baseline in the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) at Week 14 for NAL ER Compared With Placebo
Tidsramme: Baseline, Week 14
Baseline, Week 14
Relative Change from Baseline in Awake Cough Frequency at Week 14 for NAL ER Compared With Placebo
Tidsramme: Baseline, Week 14
Baseline, Week 14
Relative Change from Baseline in Sleep Cough Frequency at Week 14 for NAL ER Compared With Placebo
Tidsramme: Baseline, Week 14
Baseline, Week 14
Absolute Change from Baseline in the Patient Global Impression of Severity (PGI-S) Cough Score at Week 14 for NAL ER Compared With Placebo
Tidsramme: Baseline, Week 14
Baseline, Week 14
Absolute Change from Baseline in the Patient Global Impression of Change (PGI-C) Cough Score at Week 14 for NAL ER Compared With Placebo
Tidsramme: Baseline, Week 14
Baseline, Week 14
Proportion of Participants with Improvements by ≥1 and ≥2 Categories from Baseline on the PGI-S Cough at Week 14 for NAL ER Compared With Placebo
Tidsramme: Baseline, Week 14
Baseline, Week 14
Relative Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) at Week 14 for NAL ER Compared With Placebo
Tidsramme: Baseline, Week 14
Baseline, Week 14
Safety and Tolerability as Assessed by Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Tidsramme: Baseline up to Week 17
Baseline up to Week 17

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Trevi Therapeutics

Efterforskere

  • Studieleder: Chief Development Officer, Trevi Therapeutics, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. september 2026

Primær færdiggørelse (Anslået)

1. august 2027

Studieafslutning (Anslået)

1. oktober 2027

Datoer for studieregistrering

Først indsendt

5. oktober 2026

Først indsendt, der opfyldte QC-kriterier

5. oktober 2026

Først opslået (Faktiske)

9. oktober 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NAL03-302

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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