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

12. november 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

201

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: NAL ER

Oral tablets

Andre navn:
  • 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.
Legemiddel: Placebo

Oral tablets

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Trevi Therapeutics

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. september 2026

Primær fullføring (Antatt)

1. august 2027

Studiet fullført (Antatt)

1. oktober 2027

Datoer for studieregistrering

Først innsendt

5. oktober 2026

Først innsendt som oppfylte QC-kriteriene

5. oktober 2026

Først lagt ut (Faktiske)

9. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NAL03-302

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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