At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- PIPE-791 Dose A (drug), PIPE-791 Dose B (drug), Placebo (drug)
- How long the study runs
- Study runs about 29 months (dates as stated)
- About the drug or intervention
- PIPE-791 Dose A — drug: Participants will receive a daily oral dose of PIPE-791 in tablet form · PIPE-791 Dose B — drug: Participants will receive a daily oral dose of PIPE-791 in tablet form · Placebo — drug: Participants will receive a daily oral dose of matching Placebo in tablet form
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 40 Years and over
- Who
- All
- Number of participants
- 324
- Started
- 2026-01-08
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for idiopathic pulmonary fibrosis
- • Phase2 - 324 participants
- • 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
Who can take part?
- • Ages 40 Years and over
- • Diagnosed with idiopathic pulmonary fibrosis
Where?
- • Leicester - NIHR Leicester Biomedical Research Centre - Glenfield Hospital
- • London - St Bartholomew's Hospital - PPDS
- • Southampton - Southampton General Hospital
- • Edinburgh - Royal Infirmary of Edinburgh
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and PK of PIPE-791 in participants with a diagnosis of Idiopathic Pulmonary Fibrosis with or without background treatment. The treatment period is 26 weeks and full study duration is up to 36 weeks including Screening and Follow-Up. Approximately 324 participants will be enrolled into one of three treatment arms, PIPE-791 Dose A, PIPE-791 Dose B, or placebo.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 40 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Male or female ≥ 40 years of age at the time of Randomization.
- ✓Percent predicted (pp) FVC ≥ 40% on Screening spirometry.
- ✓Participants may enter the study whether or not they are receiving background nintedanib or pirfenidone therapy...
Who cannot take part
- ✗Those with a history of interstitial lung disease (ILD) other than IPF are not eligible.
- ✗Those with lung 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.
- ✗Female participants must not be of childbearing potential.
- ✗Additional inclusion and exclusion criteria apply.
See the full criteria
Where Is This Study? (7 UK sites)
NIHR Leicester Biomedical Research Centre - Glenfield Hospital
Leicester LE3 9QP, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351St Bartholomew's Hospital - PPDS
London EC1A 7BE, United Kingdom
Southampton General Hospital
Southampton SO16 6YD, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh EH16 4SA, United Kingdom
Perth Royal Infirmary
Perth PH1 1NX, United Kingdom
Birmingham Heartlands Hospital
Birmingham B3 3HX, United Kingdom
Royal Brompton Hospital
London SW3 6NP, United Kingdom
How to Get in Touch
Nikki Nepomuceno
Sponsor contactCONTACT
Marietta Franco
Sponsor contactCONTACT
