Pulmonary Fibrosis Clinical Trials

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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis

Status: Recruiting
Location: See all (69) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Argentina
Centro Médico Dra de Salvo - Fundacion Respirar - PPDS
RECRUITING
Buenos Aires
Consultorios Médicos Organización del Buen Ayre SRL
RECRUITING
Buenos Aires
STAT Research S.A.
RECRUITING
Buenos Aires
Instituto de Medicina Respiratoria - IMER
RECRUITING
Córdoba
Instituto Ave Pulmo
RECRUITING
Mar Del Plata
Centro Respiratorio Quilmes
RECRUITING
Quilmes
Instituto de Especialidades de la Salud Rosario - Clínica del Tórax
RECRUITING
Rosario
Instituto Médico de la Fundación Estudios Clínicos
RECRUITING
Rosario
Centro de Diagnóstico Y Rehabilitación - Santa Fe - San Luis
RECRUITING
San Luis
Centro de Investigaciones Médicas Tucumán - PPDS
RECRUITING
San Miguel De Tucumán
Centro Modelo de Cardiología-Laprida 554
RECRUITING
San Miguel De Tucumán
CIMER-Centro Integral de Medicina Respiratoria
RECRUITING
San Miguel De Tucumán
IPR-Investigaciones en Patologías Respiratorias
RECRUITING
San Miguel De Tucumán
IbaMedica
RECRUITING
Santa Fe
Australia
Royal Prince Alfred Hospital
RECRUITING
Camperdown
The Prince Charles Hospital
RECRUITING
Chermside
Greenslopes Private Hospital
RECRUITING
Greenslopes
Austin Health
RECRUITING
Heidelberg
The Alfred Hospital
RECRUITING
Melbourne
Institute for Respiratory Health
RECRUITING
Midland
TrialsWest Pty Ltd
RECRUITING
Spearwood
Westmead Hospital
RECRUITING
Westmead
Canada
Dynamic Drug Advancement Ltd.
RECRUITING
Ajax
Centre Hospitalier de l'Universite de Montreal
RECRUITING
Montreal
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
RECRUITING
Québec
Toronto General Hospital
RECRUITING
Toronto
Centre d'investigation Clinique Mauricie
RECRUITING
Trois-rivières
Vancouver General Hospital
RECRUITING
Vancouver
Dr. Anil Dhar Medicine Professional Corporation
RECRUITING
Windsor
Chile
Centro de Investigacion Curicó
RECRUITING
Curicó
CEC SpA
RECRUITING
Ñuñoa
Biocinetic Servicios Medicos Ltda
RECRUITING
Santiago
Centro de Investigacion de Enfermedades Respiratorias e Inmunologicas
RECRUITING
Viña Del Mar
Centro de Investigaciones Clinicas Vina del Mar
RECRUITING
Viña Del Mar
Israel
Assuta Ashdod University Medical Center
RECRUITING
Ashdod
The Barzilai University Medical Center
RECRUITING
Ashkelon
Shamir Medical Center
RECRUITING
Be’er Ya‘aqov
Hillel Yaffe Medical Center
RECRUITING
Hadera
Hadassah Medical Center- Ein Kerem - PPDS
RECRUITING
Jerusalem
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Meir Medical Center
RECRUITING
Kafr Saba
Rabin Medical Center - PPDS
RECRUITING
Petah Tikva
The Chaim Sheba Medical Center - PPDS
RECRUITING
Ramat Gan
Kaplan Medical Center
RECRUITING
Rehovot
Tel Aviv Sourasky Medical Center Ichilov - PPDS
RECRUITING
Tel Aviv
New Zealand
Canterbury Respiratory Research Group
RECRUITING
Christchurch
Greenlane Clinical Centre
RECRUITING
Epsom
Health New Zealand - Te Whatu Ora - Waikato Hospital
RECRUITING
Hamilton
Aotearoa Clinical Trials Trust - Middlemore Hospital - PPDS
RECRUITING
Papatoetoe
Republic of Korea
The Catholic University of Korea, Bucheon St. Mary's Hospital
RECRUITING
Bucheon-si
Gachon University Gil Medical Center
RECRUITING
Incheon
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Korea University Anam Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
Soon Chun Hyang University Hospital
RECRUITING
Seoul
The Catholic University of Korea - Eunpyeong St. Mary's Hospital
RECRUITING
Seoul
Asan Medical Center
RECRUITING
Songpa-dong
Serbia
University Clinical Center of Serbia - Koste Todorovica - PPDS
RECRUITING
Belgrade
Institute of Pulmonary Diseases of Vojvodina
RECRUITING
Kamenitz
University Clinical Center Kragujevac
RECRUITING
Kragujevac
University Clinical Center Nis
RECRUITING
Niš
United Kingdom
Birmingham Heartlands Hospital
RECRUITING
Birmingham
Royal Infirmary of Edinburgh
RECRUITING
Edinburgh
NIHR Leicester Biomedical Research Centre - Glenfield Hospital
RECRUITING
Leicester
Royal Brompton Hospital
RECRUITING
London
St Bartholomew's Hospital - PPDS
RECRUITING
London
Perth Royal Infirmary
RECRUITING
Perth
Southampton General Hospital
RECRUITING
Southampton
Contact Information
Primary
Nikki Nepomuceno
nnepomuceno@contineum-tx.com
858-333-5280
Backup
Marietta Franco
mfranco@contineum-tx.com
650-450-6634
Time Frame
Start Date: 2026-01-08
Estimated Completion Date: 2028-06
Participants
Target number of participants: 324
Treatments
Experimental: PIPE-791 Dose A
Experimental: PIPE-791 Dose B
Placebo_comparator: Placebo
Sponsors
Leads: Contineum Therapeutics

This content was sourced from clinicaltrials.gov