PIPE-791 in Idiopathic Pulmonary Fibrosis (IPF)

  • Research type

    Research Study

  • Full 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

  • IRAS ID

    1013015

  • Contact name

    Kristina Haeckl

  • Contact email

    khaeckl@contineum-tx.com

  • Sponsor organisation

    Contineum Therapeutics, Inc.

  • Research summary

    The study aims to find how effective PIPE-791 at 1mg and 3mg is compared to placebo based on changes to baseline in FVC.
    The study will effect patients with a clinical diagnosis of IPF
    The area of disease being studied is Idiopathic pulmonary fibrosis (IPF), a rare, progressive illness of the respiratory system.
    The drug being studied is PIPE-79.
    There are several specific inclusions criteria mentioned in the protocol. The study looks to recruit participants male and female that are 40 years old and older, weighing over 40kg and diagnosed with with IPF withing 7 years. It is expected that 324 patients will participate in this study
    worldwide. across approximately 150 number of sites globally.
    You will visit the study site about 11 times over about 9 months. At most visits, you will give blood samples up to about 123.7 ml
    (about 8.5 tablespoons)l of blood will be collected if you complete the study, have physical examinations,
    electrocardiograms (ECG), and lung function tests, and answer questionnaires.
    • You will receive tablet of PIPE-791 or placebo tablet once a week for 26 weeks. The study doctor will
    check to see how you respond to the study drug.
    • You should be aware that there is a 2 in 3 chance (66%) that you will receive PIPE-791, and a 1 in 3 chance to receive a
    placebo (anything that seems to be “real” medical treatment but isn’t). This will be decided by chance. Neither you nor the study
    doctor will know whether you receive PIPE-791 or placebo: this is called a double-blind study.
    • You may not get any direct benefit from entering this study. The information we get from this study may help people with
    IPF in the future.
    The study will take place in NHS and Non-NHS hospitals in the UK.

  • REC name

    South Central - Hampshire B Research Ethics Committee

  • REC reference

    25/SC/0401

  • Date of REC Opinion

    12 Feb 2026

  • REC opinion

    Further Information Favourable Opinion