Active not recruitingPHASE2INTERVENTIONAL

A Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary Fibrosis

This study is looking into a new treatment called CAL101 for a lung condition called Idiopathic Pulmonary Fibrosis (IPF). IPF causes scarring in the lungs, making it harder to breathe. Researchers want to find out if CAL101 can help prevent a decline in lung function in adults with IPF. Participants will receive either CAL101 or a placebo (a dummy medicine) through a drip once a month for six months. We'll compare how their breathing changes over time to understand if CAL101 is effective and safe. This trial is in an early stage, but it's an important step in finding better ways to manage IPF.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Calluna Pharma AS

Enrolment target

150

Start

20 Jun 2025

Estimated completion

01 Feb 2027

Idiopathic Pulmonary Fibrosis

What is this study about?

Idiopathic Pulmonary Fibrosis (IPF) is a serious lung condition where the lungs become scarred and stiff, making it increasingly difficult to breathe. We don't fully understand why it happens, and current treatments aim to slow down the disease rather than cure it. That's why research into new medicines is so important.

This study is testing a new medicine called CAL101. The main goal is to see if CAL101 can help prevent the lungs from getting worse in people with IPF. We'll be comparing CAL101 to a placebo, which looks just like the study medicine but contains no active drug. This helps us understand if any changes we see are truly due to CAL101 or if they might have happened anyway.

In this study, researchers will carefully monitor participants' lung function, especially focusing on how much air they can breathe out forcefully after taking a deep breath. This is an important measure of lung health in IPF. The study will also look at how safe CAL101 is. By involving volunteers like you, we hope to gain valuable knowledge that could lead to new or improved treatments for IPF in the future.

Key takeaways

This study is testing a new medicine (CAL101) for Idiopathic Pulmonary Fibrosis (IPF).
It aims to see if CAL101 can slow down the worsening of lung function.
Participants will receive either CAL101 or a placebo via a drip for 6 months.
The study involves regular health checks and lung function tests.
Participation will last about 11 months, including follow-up care.

Who may be eligible?

To join this study, you need to be at least 40 years old and have a confirmed diagnosis of Idiopathic Pulmonary Fibrosis (IPF). Doctors will check your recent lung scans to make sure your IPF matches what they're looking for, and your lung function must meet certain levels.

You might be able to join whether you are already taking approved IPF medications (like pirfenidone or nintedanib), as long as you've been on a stable dose for at least eight weeks. If you're not currently taking these medications, that's also fine, as long as you haven't taken them for at least eight weeks.

Some things might mean you can't take part. For example, if you have other serious lung conditions like asthma or emphysema, or if your IPF has recently gotten much worse. Also, if you have severe kidney or liver problems, or other serious health issues that could make participating unsafe or complicate the study results, you might not be able to join. The study team will review all your information carefully to see if this study is right for you.

Quick self-check

Are you 40 years old or older?
Do you have a firm diagnosis of Idiopathic Pulmonary Fibrosis?
Has your IPF diagnosis been confirmed by recent lung scans?
Are your lungs still working at a certain level (checked by breathing tests)?
Are you okay with receiving treatment through a drip once a month?
Do you not have other serious lung conditions like severe asthma or emphysema?

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'll first have a screening period that lasts about four weeks. During this time, doctors will do tests to make sure the study is right for you. Once confirmed, you'll be assigned by chance (like flipping a coin) to one of two groups: one receiving CAL101 and the other receiving a placebo (a dummy treatment). You, your doctors, and the study team won't know which one you're getting.

Over the next six months (24 weeks), you'll visit the clinic about once every four weeks to receive your study medication or placebo through a drip into your arm. During these visits, the study team will also do various health checks, lung function tests, and ask about your general well-being. After these six months, there will be a follow-up period of 16 weeks where your health will continue to be monitored, even though you won't be receiving the study treatment anymore. In total, your participation in the study from start to finish would last about 11 months.

Potential risks and benefits

Participating in a clinical trial can have potential benefits. You might receive a new investigational treatment that could potentially help manage your IPF. You'll also receive careful monitoring of your health by a dedicated medical team. However, there are also risks. CAL101 is an investigational medicine, so its full benefits and side effects aren't yet known. You might experience side effects from the study medication, or the placebo may not improve your condition. There's also no guarantee that the treatment will work for you. It's very important to remember that joining is completely voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (54)

Keck School of Medicine at USC
Los Angeles, United States
National Jewish Health
Denver, United States
Y & L Advance Health Care, Inc. d/b/a Elite Clinical Research
Miami, United States
University of Kansas Medical Center
Kansas City, United States
Pulmonix, LLC
Greensboro, United States
Southeastern Research Center
Winston-Salem, United States
Cleveland Clinic
Cleveland, United States
Temple University Hospital
Philadelphia, United States
University of Utah Health
Salt Lake City, United States
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark

+42 more sites — see the official record for the full list.

Common questions

What is Idiopathic Pulmonary Fibrosis (IPF)?

IPF is a lung disease where scar tissue builds up in your lungs, making them stiff and gradually harder to breathe.

What is CAL101?

CAL101 is a new medicine being tested to see if it can help stop the progression of IPF.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the study medicine but doesn't contain any active drug. It helps compare the new medicine's effects.

How will I receive the study medicine?

You'll receive the study medicine or placebo through a drip into your arm (intravenous infusion) once a month.

Will I know if I'm getting CAL101 or the placebo?

No, neither you nor the study team will know which treatment you are receiving. This is called 'double-blind'.