PIPE-791 tablets for people with idiopathic pulmonary fibrosis
Tests PIPE-791 against a placebo in adults with idiopathic pulmonary fibrosis.
Key facts
- Who runs it
- Contineum Therapeutics
- Where
- Amiens Cedex 1, Angers, Bobigny, Bron, Lille Cedex, Marseille, Nice, Rennes Cedex 9, and Saint-Herblain, FranceSee the 9 sitesAlso in 21 other countries, 133 sites
- Trial code
- Registry title
- Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 324 people, planned
- Started
- 8 Jan 2026
- Expected to end
- Jun 2028
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- PIPE-791 Dose A
- PIPE-791 Dose B
- Placebo
- Record updated
- 10 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 or older with idiopathic pulmonary fibrosis (IPF). They may or may not already take nintedanib or pirfenidone.
- Age
- 40 years or older
- Sex
- Women and men. Women must not be able to have children.
- Disease stage
- IPF diagnosed within 7 years before screening. A scan (HRCT) must fit usual interstitial pneumonia (UIP) or probable UIP. Lung function (percent predicted FVC) must be 40% or higher.
- Earlier treatment
- Taking nintedanib or pirfenidone is allowed, but not both at the same time. Taking neither is also allowed.
Main reasons for not taking part
- History of another interstitial lung disease besides IPF
- Pulmonary arterial hypertension that needs more than one drug
- IPF flare-up within 6 weeks of screening or during screening
- Severe kidney problems (eGFR 30 ml/min/1.73 m2 or lower)
- Moderate or severe liver impairment (Child-Pugh Class B or C)
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 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
- 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
Where in France
Also in 21 other countries, 133 sites
- Centre Hospitalier Universitaire Amiens PicardieAmiens Cedex 1, FranceTaking people
- Centre Hospitalier Universitaire D'AngersAngers, FranceTaking people
- Assistance Publique Hopitaux De ParisBobigny, FranceTaking people
- Hospices Civils de LyonBron, FranceTaking people
- Centre Hospitalier Universitaire De LilleLille Cedex, FranceTaking people
- Centre Hospitalier Regional De MarseilleMarseille, FranceTaking people
- Centre Hospitalier Universitaire de NiceNice, FranceTaking people
- Centre Hospitalier Universitaire De RennesRennes Cedex 9, FranceTaking people
- Centre Hospitalier Universitaire de NantesSaint-Herblain, FranceTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- PIPE-791 Dose ATreatment being tested
- PIPE-791 Dose BTreatment being tested
- PlaceboPlacebo, for comparison
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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
- Plain-language title
- PIPE-791 tablets for people with idiopathic pulmonary fibrosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 10 November 2026