Not recruitingRare disease

Study on Axatilimab for Patients with Idiopathic Pulmonary Fibrosis

Fast replyInvestigationalNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for Idiopathic Pulmonary Fibrosis (IPF), a lung disease that causes scarring of the lungs, making it difficult to breathe. The treatment being tested is called Axatilimab, which is given as a solution through an intravenous infusion, meaning it is administered directly into the bloodstream. The study will compare the effects of Axatilimab to a placebo to understand its impact on lung function over a period of 26 weeks.

The purpose of the study is to evaluate how Axatilimab affects lung function in people with IPF. Participants will be randomly assigned to receive either Axatilimab or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The study will last for 26 weeks, during which participants will have regular check-ups to monitor their lung function and overall health.

Throughout the study, researchers will measure the rate of decline in lung capacity, which is how much air the lungs can hold, and observe any changes in symptoms or disease progression. The study aims to provide valuable information on the safety and effectiveness of Axatilimab as a potential treatment for IPF, helping to improve the quality of life for those affected by this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization and initial assessment
Upon joining the study, you will be randomly assigned to receive either the investigational medication, axatilimab, or a placebo. This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.
An initial assessment will be conducted to establish baseline measurements of your lung function. This includes tests such as forced vital capacity (FVC) and diffusion capacity for carbon monoxide (DLCO).
Step 2
Treatment administration
The treatment involves receiving an intravenous infusion. The specific schedule and dosage will be determined by the study protocol, and you will be informed of the exact timing and frequency of these infusions.
The treatment period lasts for 26 weeks, during which you will continue to receive either axatilimab or placebo.
Step 3
Ongoing assessments
Throughout the 26-week period, regular assessments will be conducted to monitor your lung function and overall health. These assessments will include repeated measurements of FVC and DLCO.
You will also be asked to complete questionnaires, such as the St. George’s Respiratory Questionnaire (SGRQ), to evaluate changes in your respiratory symptoms and quality of life.
Step 4
End of treatment evaluation
At the end of the 26-week treatment period, a final evaluation will be conducted to assess the effects of the treatment on your lung function and overall health.
This evaluation will include the same tests and questionnaires used during the initial and ongoing assessments.

Who can join the trial?

16 criteria

Must be a male or female aged 40 years or older on the day of signing the consent form.
Must be able to give signed informed consent and agree to follow the study requirements.
Must have considered all other treatment options, including possible lung transplantation, before joining the study.
Must have a documented diagnosis of **Idiopathic Pulmonary Fibrosis (IPF)**, which is a lung condition, according to specific guidelines.
Must have a **High-Resolution Computed Tomography (HRCT)** scan confirming the IPF diagnosis. This is a detailed type of lung scan.
Must meet specific criteria based on lung scan patterns or have a lung biopsy that supports the diagnosis.
check
Must meet one of the following medication criteria for IPF:
- Never taken certain IPF medications like nintedanib or pirfenidone, or stopped them for specific reasons.
- If taking these medications, must have been on a stable dose for at least 12 weeks before the study.
- If previously taken and stopped these medications, must have stopped at least 4 weeks before the study.
- check
  Must meet specific lung function criteria during the screening period, including:
  - **Forced Vital Capacity (FVC)** of at least 45% of the predicted normal value. FVC is a measure of lung capacity.
  - **Forced Expiratory Volume in 1 second (FEV1)** to FVC ratio of at least 0.7. This measures how well you can exhale.
  - **Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)** between 30% and 90% of predicted, adjusted for hemoglobin levels. This measures how well your lungs transfer oxygen.
  - Must be able to perform acceptable lung function tests.
  - Must have an estimated life expectancy of at least 12 months for conditions not related to IPF.
  - Male and female participants of childbearing potential must agree to use highly effective birth control methods during the study and for 90 days after the last dose. This includes not donating eggs or sperm during this time.
  - Must be able to comply with the study requirements according to the investigator's judgment.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Turin, Italy
Responsive
Azienda Ospedaliera Universitaria Senese
Siena, Italy
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Axatilimab is a medication being studied for its potential to improve lung function in people with Idiopathic Pulmonary Fibrosis (IPF). This condition causes scarring of the lungs, making it difficult to breathe. The trial aims to determine if axatilimab can help reduce the progression of this scarring and improve breathing over a 26-week period.

Axatilimab

What is already known about the treatment

Axatilimab – Axatilimab is administered as an injection, typically given under the skin. It is currently being studied in clinical trials for its potential use in treating idiopathic pulmonary fibrosis, a condition that causes scarring of the lungs. The medication works by targeting specific proteins involved in the inflammatory process, aiming to reduce lung damage and improve breathing. Axatilimab is classified as a monoclonal antibody, which is a type of drug designed to interact with the immune system to help manage disease symptoms.

Investigated diseases

Idiopathic Pulmonary Fibrosis – Idiopathic pulmonary fibrosis is a chronic lung disease characterized by the thickening and scarring of lung tissue, leading to a progressive decline in lung function. The exact cause of this condition is unknown, and it primarily affects middle-aged and older adults. As the disease progresses, individuals may experience increasing difficulty in breathing, persistent dry cough, and fatigue. Over time, the scarring of lung tissue becomes more extensive, further impairing the ability to breathe deeply. This condition can significantly impact the quality of life, as it limits physical activity due to breathlessness. The progression of idiopathic pulmonary fibrosis varies among individuals, with some experiencing a rapid decline in lung function.