Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
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
- Idiopathic Pulmonary Fibrosis
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Contineum Therapeutics
- Enrolment target
- 324
- Started
- 8 January 2026
- Main results due
- May 2028
- Study sites
- 81
- Registry updated
- 29 September 2026
Can you take part?
- Aged 40 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(81)
Instituto Ave Pulmo
Mar del Plata, Buenos Aires, Argentina
Recruiting
Centro Respiratorio Quilmes
Quilmes, Buenos Aires, Argentina
Recruiting
CINME S.A. - Centro de Investigaciones Metabólicas - Viamonte 2213/2215
Buenos Aires, Buenos Aires F.D., Argentina
Recruiting
Instituto de Especialidades de la Salud Rosario - Clínica del Tórax
Rosario, Santa Fe Province, Argentina
Recruiting
Instituto Médico de la Fundación Estudios Clínicos
Rosario, Santa Fe Province, Argentina
Recruiting
Centro de Diagnóstico Y Rehabilitación - Santa Fe - San Luis
San Luis, Santa Fe Province, Argentina
Recruiting
Centro de Investigaciones Médicas Tucumán - PPDS
San Miguel de Tucumán, Tucumán Province, Argentina
Recruiting
CIMER-Centro Integral de Medicina Respiratoria
San Miguel de Tucumán, Tucumán Province, Argentina
Recruiting
IPR-Investigaciones en Patologías Respiratorias
San Miguel de Tucumán, Tucumán Province, Argentina
Recruiting
Centro Modelo de Cardiología-Laprida 554
San Miguel de Tucumán, Tucumán Province, Argentina
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, Australia
Recruiting
Westmead Hospital
Westmead, New South Wales, Australia
Recruiting
The Prince Charles Hospital
Chermside, Queensland, Australia
Recruiting
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Recruiting
Austin Health
Heidelberg, Victoria, Australia
Recruiting
The Alfred Hospital
Melbourne, Victoria, Australia
Recruiting
Institute for Respiratory Health
Midland, Western Australia, Australia
Recruiting
TrialsWest Pty Ltd
Spearwood, Western Australia, Australia
Recruiting
Vancouver General Hospital
Vancouver, British Columbia, Canada
Recruiting
Dynamic Drug Advancement Ltd.
Ajax, Ontario, Canada
Recruiting
Toronto General Hospital
Toronto, Ontario, Canada
Recruiting
Dr. Anil Dhar Medicine Professional Corporation
Windsor, Ontario, Canada
Recruiting
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
Québec, Quebec, Canada
Recruiting
Centre d'investigation Clinique Mauricie
Trois-Rivières, Quebec City, Canada
Recruiting
Centro de Investigacion Curicó
Curicó, Maule Region, Chile
Recruiting
CEC SpA
Ñuñoa, Santiago Metropolitan, Chile
Recruiting
Biocinetic Servicios Medicos Ltda
Santiago, Santiago Metropolitan, Chile
Recruiting
Centro de Investigacion de Enfermedades Respiratorias e Inmunologicas
Viña del Mar, Valparaiso, Chile
Recruiting
Centro de Investigaciones Clinicas Vina del Mar
Viña del Mar, Valparaiso, Chile
Recruiting
CHU de Nice-Hôpital Pasteur
Nice, Alpes-Maritimes, France
Recruiting
General Hospital of Thessaloniki ''G. Papanikolaou''
Exochi, Thessaloniki, Greece
Recruiting
Shamir Medical Center
Be’er Ya‘aqov, Central District, Israel
Recruiting
Meir Medical Center
Kafr Saba, Central District, Israel
Recruiting
Rabin Medical Center - PPDS
Petah Tikva, Central District, Israel
Recruiting
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Central District, Israel
Recruiting
Kaplan Medical Center
Rehovot, Central District, Israel
Recruiting
Hillel Yaffe Medical Center
Hadera, Haifa District, Israel
Recruiting
Hadassah Medical Center- Ein Kerem - PPDS
Jerusalem, Jerusalem, Israel
Recruiting
Assuta Ashdod University Medical Center
Ashdod, Southern District, Israel
Recruiting
The Barzilai University Medical Center
Ashkelon, Southern District, Israel
Recruiting
Shaare Zedek Medical Center
Jerusalem, Yerushala, Israel
Recruiting
Tel Aviv Sourasky Medical Center Ichilov - PPDS
Tel Aviv, Israel
Recruiting
Greenlane Clinical Centre
Epsom, Auckland, New Zealand
Recruiting
Aotearoa Clinical Trials Trust - Middlemore Hospital - PPDS
Papatoetoe, Auckland, New Zealand
Recruiting
Canterbury Respiratory Research Group
Christchurch, Canterbury, New Zealand
Recruiting
Health New Zealand - Te Whatu Ora - Waikato Hospital
Hamilton, Waikato Region, New Zealand
Recruiting
Clinica Internacional - PPDS
Lima, Lima Province, Peru
Recruiting
Clinica Providencia - PPDS
San Miguel, Lima region, Peru
Recruiting
SpiroClinic
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Recruiting
Centrum Medycyny Oddechowej Mroz sp. j.
Bialystok, Podlaskie Voivodeship, Poland
Recruiting
ULS de São José, EPE - Hospital de Santa Marta
Lisbon, Portugal
Recruiting
Institute of Pulmonary Diseases of Vojvodina
Kamenitz, Syrmia, Serbia
Recruiting
University Clinical Center of Serbia - Koste Todorovica - PPDS
Belgrade, Serbia
Recruiting
University Clinical Center Kragujevac
Kragujevac, Serbia
Recruiting
Showing 60 of 81 sites — filter to narrow it down. 81 of the 81 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07284459. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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