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Study on the Effects of MBS2320 for Patients with Idiopathic Pulmonary Fibrosis (IPF)

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What is this trial about?

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

This clinical trial is focused on studying a disease called Idiopathic Pulmonary Fibrosis (IPF). IPF is a condition where the lungs become scarred and breathing becomes difficult over time. The study is testing a new treatment called MBS2320, which is taken as a capsule. The purpose of the study is to see how effective and safe MBS2320 is for people with IPF.

Participants in the study will take MBS2320 or a placebo, which looks like the real medication but does not contain the active ingredient. The study will last for 12 weeks, during which participants will take the medication daily. Researchers will monitor changes in lung function, specifically looking at something called forced vital capacity (FVC), which measures how much air a person can exhale after taking a deep breath. This will help determine if MBS2320 can improve breathing in people with IPF.

Throughout the study, participants will have regular check-ups to assess their health and any changes in their condition. The study aims to provide valuable information on whether MBS2320 can be a beneficial treatment option for those living with IPF. Participants' progress will be closely monitored to ensure their safety and to gather data on the treatment's effects.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will be required to sign an informed consent form. This form outlines the study's requirements and restrictions.
The participant must be 40 years or older and have a confirmed diagnosis of idiopathic pulmonary fibrosis (IPF).
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes a high-resolution computed tomography (hrCT) scan of the chest and tests to measure lung function, such as forced vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide (DLCO).
Participants must have an FVC of at least 45% of the predicted value and a DLCO between 25% and 80% of the predicted value.
Step 3
Medication administration
Participants will be randomly assigned to receive either the study medication, MBS2320, or a placebo. Both are administered in capsule form.
The dosage for MBS2320 is 40 mg, taken orally once daily for a duration of 12 weeks.
Step 4
Ongoing monitoring
Throughout the 12-week period, participants will undergo regular monitoring to assess the medication's effects. This includes measuring changes in lung function, such as FVC and DLCO.
Participants will also be monitored for any side effects or adverse reactions to the medication.
Step 5
Final assessment
At the end of the 12-week period, a final assessment will be conducted to evaluate the overall impact of the medication on lung function and disease progression.
The primary focus will be on changes in FVC from the baseline measurement.

Who can join the trial?

11 criteria

Participant must be 40 years or older at the time of signing the informed consent.
Has a life expectancy of at least 12 months, as determined by the study doctor.
According to the study doctor's best judgment, can follow the study's requirements.
Has a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) based on specific guidelines and confirmed by a chest scan.
Has a Forced Vital Capacity (FVC) of at least 45% of what is predicted for a healthy person. FVC is a measure of lung function.
Has a Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) between 25% and 80% of what is predicted, adjusted for hemoglobin levels. DLCO measures how well the lungs transfer gas from the air to the blood.
Can walk a minimum distance of 150 meters in a 6-Minute Walk Test (6MWT).
Has a FEV1/FVC ratio greater than 0.70. This ratio is another measure of lung function.
If taking anti-fibrotic medications, only the approved treatments of nintedanib or pirfenidone are allowed. Participants must be on a stable dose for at least 8 weeks before the study starts and are expected to remain stable during the study. A combination of both medications is not allowed. If not taking these medications, there must be a valid reason, such as a medical reason not to take them, previous treatment stopped due to lack of response or side effects, not meeting criteria for treatment, or personal choice.
Male and female participants must use contraception according to local regulations for clinical studies.
Capable of giving signed informed consent, which means understanding and agreeing to the study's requirements and restrictions.

Who cannot join the trial?

10 criteria

Having any other lung disease besides Idiopathic Pulmonary Fibrosis (IPF). IPF is a condition where the lungs become scarred and breathing becomes difficult.
Having a history of severe heart problems, such as a heart attack or heart failure. Heart failure is when the heart doesn't pump blood as well as it should.
Having uncontrolled high blood pressure. This means blood pressure that is not managed well with medication or lifestyle changes.
Having liver or kidney disease that is severe. The liver and kidneys are important organs that help filter and clean the blood.
Being pregnant or breastfeeding. This is to ensure the safety of both the mother and the baby.
Having a history of cancer within the last 5 years, except for some skin cancers that are not serious.
Having an active infection that requires treatment with antibiotics or other medications.
Using certain medications that might interfere with the study treatment.
Having participated in another clinical trial within the last 30 days.
Having a known allergy to the study medication or similar drugs.

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Verified sites

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Responsive
Azienda Ospedaliera Universitaria Senese
Siena, Italy
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Essen, Germany

Trial locations

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Investigated drugs

MBS2320 is an investigational medication being studied for its potential to help patients with Idiopathic Pulmonary Fibrosis (IPF). This medication is taken orally every day. The main goal of the study is to see how well MBS2320 can improve lung function, specifically by measuring changes in the amount of air a person can exhale after taking a deep breath, known as forced vital capacity (FVC). The study aims to determine if MBS2320 can make a significant difference in lung capacity for people with IPF over a 12-week period.

Mbs2320

What is already known about the treatment

MBS2320 – This medication is administered orally and is currently being studied in a Phase 2 clinical trial for its effectiveness and safety in treating Idiopathic Pulmonary Fibrosis (IPF). The main therapeutic indication for MBS2320 is to improve lung function in patients with IPF, as measured by changes in forced vital capacity. At the molecular level, MBS2320 is believed to work by modulating specific pathways involved in lung tissue repair and inflammation. It is classified pharmacologically as an investigational drug, as it is still under clinical evaluation and not yet approved for general medical use.

Investigated diseases

Idiopathic Pulmonary Fibrosis – Idiopathic Pulmonary Fibrosis (IPF) 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 IPF is unknown, but it results in the stiffening of the lungs, making it difficult for them to expand and contract. Over time, this scarring, known as fibrosis, worsens, causing shortness of breath and a persistent dry cough. As the disease progresses, individuals may experience fatigue, weight loss, and clubbing of the fingers. The progression of IPF can vary, with some people experiencing a slow decline in lung function, while others may have a more rapid deterioration.