RecruitingPhase 2NCT07284459

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


Sponsor

Contineum Therapeutics

Enrollment

324 participants

Start Date

Jan 8, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called PIPE-791 Dose A, a drug called PIPE-791 Dose B, and others for people with idiopathic pulmonary fibrosis. The study is currently recruiting participants at 50 locations. People eligible for this study include aged 40 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPIPE-791 Dose A

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

DRUGPIPE-791 Dose B

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

DRUGPlacebo

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


Locations(57)

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 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

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

Toronto General Hospital

Toronto, Ontaria, Canada

Dynamic Drug Advancement Ltd.

Ajax, Ontario, Canada

Dr. Anil Dhar Medicine Professional Corporation

Windsor, Ontario, Canada

Centre d'investigation Clinique Mauricie

Trois-Rivières, Quebec, Canada

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

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

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

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

View Full Details on ClinicalTrials.gov

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NCT07284459


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