PIPE-791 tablets for people with idiopathic pulmonary fibrosis
Tests PIPE-791 against a placebo in adults with idiopathic pulmonary fibrosis.
Plain-language title generated from the registry record
Registry title: Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Key facts
- Where
- Bamberg, Coswig, Essen, Frankfurt am Main, Giessen, Loewenstein, München, and Rosenheim, GermanySee the 8 sites
- Phase
- Phase 2
Where in Germany
- CIMS Studienzentrum Bamberg GmbHBamberg, GermanyTaking people
- GWT-Tud GmbHCoswig, GermanyTaking people
- Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbHEssen, GermanyTaking people
- IKF Pneumologie GmbH & Co. KGFrankfurt am Main, GermanyTaking people
- Universitaetsklinikum Giessen und Marburg GmbHGiessen, GermanyTaking people
- SLK-Kliniken Heilbronn GmbHLoewenstein, GermanyTaking people
- Pneumologisches Studienzentrum München-WestMünchen, GermanyTaking people
- RoMed Klinikum RosenheimRosenheim, GermanyTaking people
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?
Trial details
- Who runs it
- Contineum Therapeutics
- Trial code
- NCT07284459EU 2025-521901-42-00
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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.