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Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Sponsor: Contineum Therapeutics
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.
Official title: 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
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
324
Start Date
2026-01-08
Completion Date
2028-06
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
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
Locations (92)
Instituto Ave Pulmo
Mar del Plata, Buenos Aires, Argentina
Centro Respiratorio Quilmes
Quilmes, Buenos Aires, Argentina
CINME S.A. - Centro de Investigaciones Metabólicas - Viamonte 2213/2215
Buenos Aires, Buenos Aires F.D., Argentina
Instituto de Especialidades de la Salud Rosario - Clínica del Tórax
Rosario, Santa Fe Province, Argentina
Instituto Médico de la Fundación Estudios Clínicos
Rosario, Santa Fe Province, Argentina
Centro de Diagnóstico Y Rehabilitación - Santa Fe - San Luis
San Luis, Santa Fe Province, Argentina
Centro de Investigaciones Médicas Tucumán - PPDS
San Miguel de Tucumán, Tucumán Province, Argentina
CIMER-Centro Integral de Medicina Respiratoria
San Miguel de Tucumán, Tucumán Province, Argentina
IPR-Investigaciones en Patologías Respiratorias
San Miguel de Tucumán, Tucumán Province, Argentina
Centro Modelo de Cardiología-Laprida 554
San Miguel de Tucumán, Tucumán Province, Argentina
STAT Research S.A.
Buenos Aires, Argentina
Consultorios Médicos Organización del Buen Ayre SRL
Buenos Aires, Argentina
Centro Médico Dra de Salvo - Fundacion Respirar - PPDS
Buenos Aires, Argentina
Instituto de Medicina Respiratoria - IMER
Córdoba, Argentina
IbaMedica
Santa Fe, Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Austin Health
Heidelberg, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Institute for Respiratory Health
Midland, Western Australia, Australia
TrialsWest Pty Ltd
Spearwood, Western Australia, Australia
Vancouver General Hospital
Vancouver, British Columbia, Canada
Dynamic Drug Advancement Ltd.
Ajax, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Dr. Anil Dhar Medicine Professional Corporation
Windsor, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
Québec, Quebec, Canada
Centre d'investigation Clinique Mauricie
Trois-Rivières, Quebec City, Canada
Centro de Investigacion Curicó
Curicó, Maule Region, Chile
CEC SpA
Ñuñoa, Santiago Metropolitan, Chile
Biocinetic Servicios Medicos Ltda
Santiago, Santiago Metropolitan, Chile
Centro de Investigacion de Enfermedades Respiratorias e Inmunologicas
Viña del Mar, Valparaiso, Chile
Centro de Investigaciones Clinicas Vina del Mar
Viña del Mar, Valparaiso, Chile
CHU de Nice-Hôpital Pasteur
Nice, Alpes-Maritimes, France
University General Hospital - General Hospital of West Attica H Agia Varvara
Chaïdári, Anatoliki Attiki, Greece
University General Hospital of Alexandroupolis
Alexandroupoli, Evros, Greece
University General Hospital of Ioannina
Ioannina, Ioannina, Greece
PAGNI-University General Hospital of Heraklion
Heraklion, Irakleio, Greece
General Hospital of Thessaloniki ''G. Papanikolaou''
Exochi, Thessaloniki, Greece
Shamir Medical Center
Be’er Ya‘aqov, Central District, Israel
Meir Medical Center
Kafr Saba, Central District, Israel
Rabin Medical Center - PPDS
Petah Tikva, Central District, Israel
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Central District, Israel
Kaplan Medical Center
Rehovot, Central District, Israel
Hillel Yaffe Medical Center
Hadera, Haifa District, Israel
Hadassah Medical Center- Ein Kerem - PPDS
Jerusalem, Jerusalem, Israel
Assuta Ashdod University Medical Center
Ashdod, Southern District, Israel
The Barzilai University Medical Center
Ashkelon, Southern District, Israel
Shaare Zedek Medical Center
Jerusalem, Yerushala, Israel
Tel Aviv Sourasky Medical Center Ichilov - PPDS
Tel Aviv, Israel
Greenlane Clinical Centre
Epsom, Auckland, New Zealand
Aotearoa Clinical Trials Trust - Middlemore Hospital - PPDS
Papatoetoe, Auckland, New Zealand
Canterbury Respiratory Research Group
Christchurch, Canterbury, New Zealand
Health New Zealand - Te Whatu Ora - Waikato Hospital
Hamilton, Waikato Region, New Zealand
Clinica Internacional - PPDS
Lima, Lima Province, Peru
Clinica Ricardo Palma - PPDS
Lima, Lima Province, Peru
Clinica Providencia - PPDS
San Miguel, Lima region, Peru
Clinica San Pablo Surco
Surco, Lima region, Peru
SpiroClinic
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Alergopneuma Centrum Medyczne - Swidnik
Świdnik, Lublin Voivodeship, Poland
Centrum Medycyny Oddechowej Mroz sp. j.
Bialystok, Podlaskie Voivodeship, Poland
PULMAG s.c.
Sosnowiec, Silesian Voivodeship, Poland
ULS de São José, EPE - Hospital de Santa Marta
Lisbon, Portugal
Institute of Pulmonary Diseases of Vojvodina
Kamenitz, Syrmia, Serbia
University Clinical Center of Serbia - Koste Todorovica - PPDS
Belgrade, Serbia
University Clinical Center Kragujevac
Kragujevac, Serbia
University Clinical Center Nis
Niš, Serbia
The Catholic University of Korea - Eunpyeong St. Mary's Hospital
Seoul, Eunpyeong District, South Korea
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Severance Hospital Yonsei University Health System
Seoul, Seodaemun, South Korea
Samsung Medical Center
Seoul, Seoul, South Korea
Asan Medical Center
Songpa-dong, Seoul, South Korea
Soon Chun Hyang University Hospital
Seoul, Yongsan-gu, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Korea University Anam Hospital
Seoul, South Korea
Hospital Universitario Virgen de la Victoria
Málaga, Malaga, Spain
Hospital Clinico Universitario de Valencia
Valencia, Valencia, Spain
Changhua Christian Hospital
Changhua, Taiwan
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
NIHR Leicester Biomedical Research Centre - Glenfield Hospital
Leicester, England, United Kingdom
St Bartholomew's Hospital - PPDS
London, Greater London, United Kingdom
Southampton General Hospital
Southampton, Hampshire, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom
Perth Royal Infirmary
Perth, Scotland, United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Royal Brompton Hospital
London, United Kingdom