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Clinical Trials in the UK / NCT07284459
Recruiting Phase 2

Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis

NCT07284459 · tracked via the Priya Life Science UK tracker
Sponsor
Contineum Therapeutics
Phase
Phase 2
Started
2026-01-08
Last updated
2026-09-11

Condition(s) studied

Idiopathic Pulmonary Fibrosis

Investigational drug(s) / intervention(s)

PIPE-791 Dose APIPE-791 Dose BPlacebo

PIPE-791 Dose A: Participants will receive a daily oral dose of PIPE-791 in tablet form

PIPE-791 Dose B: Participants will receive a daily oral dose of PIPE-791 in tablet form

Placebo: Participants will receive a daily oral dose of matching Placebo in tablet form

Study summary

This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of PIPE-791 in participants with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) with or without background treatment.

Eligibility

Sex
ALL
Min age
40 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: * Male or female ≥ 40 years of age at the time of Randomization. * A diagnosis of IPF within 7 years prior to Screening, based on the 2022 ATS/ERS/JRS/ALAT practice guideline as confirmed by the Investigator, and a centrally read screening HRCT consistent with usual interstitial pneumonia (UIP) or probable UIP. * Percent predicted (pp) FVC ≥ 40% on Screening spirometry. * Participants may enter the study whether or not they are receiving background nintedanib or pirfenidone therapy approved for the treatment of IPF, but not both concurrently. Key Exclusion Criteria: * Those with a history of interstitial lung disease (ILD) other than IPF are not eligible. * Those with pulmonary arterial hypertension (PAH) requiring multi-drug therapy are not eligible. * Those who have experienced an IPF exacerbation within 6 weeks of Screening, or during Screening, are not eligible. * Those with an estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) (Inker 2021) or who have Child-Pugh Class B or C hepatic impairment are not eligible. * Female participants must not be of childbearing potential. Additional inclusion and exclusion criteria apply.

Primary outcome measure(s)

Trial sites (70)

FacilityCityRegionStatus
Instituto Ave Pulmo Mar del Plata Buenos Aires Recruiting
Centro Respiratorio Quilmes Quilmes Buenos Aires Recruiting
CINME S.A. - Centro de Investigaciones Metabólicas - Viamonte 2213/2215 Buenos Aires Buenos Aires F.D. Recruiting
Instituto de Especialidades de la Salud Rosario - Clínica del Tórax Rosario Santa Fe Province Recruiting
Instituto Médico de la Fundación Estudios Clínicos Rosario Santa Fe Province Recruiting
Centro de Diagnóstico Y Rehabilitación - Santa Fe - San Luis San Luis Santa Fe Province Recruiting
Centro de Investigaciones Médicas Tucumán - PPDS San Miguel de Tucumán Tucumán Province Recruiting
CIMER-Centro Integral de Medicina Respiratoria San Miguel de Tucumán Tucumán Province Recruiting
IPR-Investigaciones en Patologías Respiratorias San Miguel de Tucumán Tucumán Province Recruiting
Centro Modelo de Cardiología-Laprida 554 San Miguel de Tucumán Tucumán Province Recruiting
STAT Research S.A. Buenos Aires Argentina Recruiting
Consultorios Médicos Organización del Buen Ayre SRL Buenos Aires Argentina Recruiting
Centro Médico Dra de Salvo - Fundacion Respirar - PPDS Buenos Aires Argentina Recruiting
Instituto de Medicina Respiratoria - IMER Córdoba Argentina Recruiting
IbaMedica Santa Fe Argentina Recruiting
Royal Prince Alfred Hospital Camperdown New South Wales Recruiting
Westmead Hospital Westmead New South Wales Recruiting
The Prince Charles Hospital Chermside Queensland Recruiting
Greenslopes Private Hospital Greenslopes Queensland Recruiting
Austin Health Heidelberg Victoria Recruiting
The Alfred Hospital Melbourne Victoria Recruiting
Institute for Respiratory Health Midland Western Australia Recruiting
TrialsWest Pty Ltd Spearwood Western Australia Recruiting
Vancouver General Hospital Vancouver British Columbia Recruiting
Dynamic Drug Advancement Ltd. Ajax Ontario Recruiting
Toronto General Hospital Toronto Ontario Recruiting
Dr. Anil Dhar Medicine Professional Corporation Windsor Ontario Recruiting
Centre Hospitalier de l'Universite de Montreal Montreal Quebec Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval Québec Quebec Recruiting
Centre d'investigation Clinique Mauricie Trois-Rivières Quebec City Recruiting
Centro de Investigacion Curicó Curicó Maule Region Recruiting
CEC SpA Ñuñoa Santiago Metropolitan Recruiting
Biocinetic Servicios Medicos Ltda Santiago Santiago Metropolitan Recruiting
Centro de Investigacion de Enfermedades Respiratorias e Inmunologicas Viña del Mar Valparaiso Recruiting
Centro de Investigaciones Clinicas Vina del Mar Viña del Mar Valparaiso Recruiting
Shamir Medical Center Be’er Ya‘aqov Central District Recruiting
Meir Medical Center Kafr Saba Central District Recruiting
Rabin Medical Center - PPDS Petah Tikva Central District Recruiting
The Chaim Sheba Medical Center - PPDS Ramat Gan Central District Recruiting
Kaplan Medical Center Rehovot Central District Recruiting

+ 30 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07284459 on ClinicalTrials.gov ↗ ← All trials in the UK