RecruitingPHASE2INTERVENTIONAL

Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis

This research study is looking into a new treatment called PIPE-791 for Idiopathic Pulmonary Fibrosis (IPF), a serious lung condition. The main goals are to find out how effective PIPE-791 is at treating IPF, if it's safe to use, and if patients find it tolerable. This study is known as a 'Phase 2' trial, which means we're still in the earlier stages of testing the medicine in a group of people to gather more information. Patients will receive either PIPE-791 at one of two doses or a dummy treatment (placebo). It's a global study, taking place in different locations, and will involve around 324 people living with IPF.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Contineum Therapeutics

Enrolment target

324

Start

08 Jan 2026

Estimated completion

01 Jun 2028

Idiopathic Pulmonary Fibrosis

What is this study about?

Idiopathic Pulmonary Fibrosis (IPF) is a lung condition that causes scarring in your lungs, making it harder to breathe. This scarring tends to get worse over time. Scientists are always working to find new ways to help people with IPF, and that's where studies like this one come in.

This particular study is focusing on a new medicine called PIPE-791. The main purpose is to see if PIPE-791 can help slow down the scarring or improve lung function in people with IPF. We also want to understand if it causes any side effects and how well people can cope with taking it. This is a chance for people with IPF to potentially get access to a new treatment that might make a difference.

This is a 'Phase 2' study. This means it's not the very first time this medicine has been tested, but we're still gathering important information on its effectiveness and safety in a larger group of patients before it can be considered for wider use. The study aims to compare PIPE-791 against a 'placebo', which is a dummy treatment that looks just like the real medicine but contains no active drug. This helps us understand if any improvements seen are truly due to PIPE-791.

Key takeaways

Tests new medicine PIPE-791 for Idiopathic Pulmonary Fibrosis (IPF).
Aims to check effectiveness, safety, and tolerability.
Compares PIPE-791 to a non-active dummy treatment (placebo).
Involves around 324 people living with IPF.
Participation lasts up to 36 weeks in total.

Who may be eligible?

To be considered for this study, you would need to be at least 40 years old. You must have been diagnosed with Idiopathic Pulmonary Fibrosis (IPF) within the last 7 years, and doctors will need to confirm this diagnosis with special scans. Your lung function, specifically a measure called FVC, needs to be at least 40% of what is expected for someone your age and size.

You might be able to join whether you are already taking other approved IPF medications (like nintedanib or pirfenidone, but not both at once) or not. However, there are some reasons why you wouldn't be able to join. For example, if you have other types of lung scarring conditions apart from IPF, or a severe heart condition called pulmonary arterial hypertension.

Also, if you've had a recent severe worsening of your IPF in the last 6 weeks, or if you have severe kidney or liver problems, you wouldn't be eligible. The research team will carefully check all these details to make sure the study is right and safe for you.

Quick self-check

Are you 40 years old or older?
Have you been diagnosed with IPF within the last 7 years?
Do you have a certain level of lung function (FVC at least 40%)?
Are you NOT currently dealing with another serious lung scarring condition (apart from IPF)?
Have you NOT had a recent severe worsening of your IPF in the last 6 weeks?
Do you NOT have severe kidney or liver problems?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would be involved in the study for up to 36 weeks in total. This includes an initial check-up period, 26 weeks where you would be taking the study medicine (or placebo), and then a follow-up period. There will be several visits to the clinic during this time for check-ups, blood tests, lung function tests, and to get your study medication.

Before you start, you'll go through a screening process to make sure you're suitable for the study. Once accepted, you'll be randomly assigned to one of three groups: one group will receive a lower dose of PIPE-791, another group will receive a higher dose, and the third group will receive a placebo (dummy drug). Neither you nor your study doctor will know which group you are in. You will take the study medicine as instructed for 26 weeks. After you finish taking the medicine, there will be some follow-up visits to ensure your health is monitored.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that PIPE-791 might help improve your IPF or slow its progression, and you would be contributing to medical research that could help others in the future. However, there's also a chance the treatment might not work for you, or you might receive the placebo. There could be side effects from taking PIPE-791, similar to any medication, and these would be carefully monitored by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (17)

Westmead Hospital
Westmead, Australia· Recruiting
Institute for Respiratory Health
Midland, Australia· Recruiting
TrialsWest Pty Ltd
Spearwood, Australia· Recruiting
Dynamic Drug Advancement Ltd.
Ajax, Canada· Recruiting
Dr. Anil Dhar Medicine Professional Corporation
Windsor, Canada· Recruiting
Centre d'investigation Clinique Mauricie
Trois-Rivières, Canada· Recruiting
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Israel· Recruiting
Assuta Ashdod University Medical Center
Ashdod, Israel· Recruiting
The Barzilai University Medical Center
Ashkelon, Israel· Recruiting
Shaare Zedek Medical Center
Jerusalem, Israel· Recruiting
Tel Aviv Sourasky Medical Center Ichilov - PPDS
Tel Aviv, Israel· Recruiting
Gachon University Gil Medical Center
Incheon, South Korea· Recruiting

+5 more sites — see the official record for the full list.

Common questions

What is Idiopathic Pulmonary Fibrosis (IPF)?

IPF is a disease where scar tissue builds up in your lungs, making it difficult to breathe. 'Idiopathic' means doctors don't know exactly why it happens.

What does 'Phase 2' mean for this study?

Phase 2 means the medicine has been tested safely in a small group and is now being tested in a larger group of patients to see if it works and to find the best dose.

Will I know if I'm getting the real medicine?

No, this is a 'blinded' study. To make the results fair, neither you nor the study doctors will know if you're getting PIPE-791 or the placebo until the study is over.

Can I take my usual IPF medicines during the study?

You might be able to, depending on which ones you take. The study team will check your current medications very carefully to see if they are allowed with the study drug.

How long will I be involved in the study?

You could be involved for up to 36 weeks, including screening, 26 weeks of treatment, and a follow-up period.

How to find out more

Nikki Nepomuceno

nnepomuceno@contineum-tx.com 858-333-5280 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.