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Tests treatment safety and results for Idiopathic Pulmonary Fibrosis
Official title Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
ClinicalTrials.gov ID: NCT07284459
What this study is testing
What is PIPE-791 Dose A?
PIPE-791 Dose A is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for idiopathic pulmonary fibrosis.
Also referred to as PIPE-791.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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 who have experienced an IPF exacerbation within 6 weeks of Screening, or during Screening, 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)...
- Female participants must not be of childbearing potential. Additional inclusion and exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- San Miguel de Tucumán, Tucumán Province, Argentina
- Buenos Aires, Argentina
- Santa Fe, Argentina
- Westmead, New South Wales, Australia
- Chermside, Queensland, Australia
- Heidelberg, Victoria, Australia
- Melbourne, Victoria, Australia
- Midland, Western Australia, Australia
- Spearwood, Western Australia, Australia
- Vancouver, British Columbia, Canada
- Toronto, Ontaria, Canada
- Ajax, Ontario, Canada
- Windsor, Ontario, Canada
- Trois-Rivières, Quebec, Canada
- Be’er Ya‘aqov, Central District, Israel
- Kafr Saba, Central District, Israel
- Petah Tikva, Central District, Israel
- Ramat Gan, Central District, Israel
- Rehovot, Central District, Israel
- Hadera, Haifa District, Israel
+ 27 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Miguel de Tucumán, Tucumán Province, Argentina; Buenos Aires, Argentina; Santa Fe, Argentina; Westmead, New South Wales, Australia; Chermside, Queensland, Australia; Heidelberg, Victoria, Australia and 41 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.