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

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What is this study about?

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.

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).

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Universitaet Leipzig	Leipzig	Germany
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz	Szekesfehervar	Hungary
Evangelismos S.A.	Athens	Greece
General University Hospital Of Larissa	Larissa	Greece
University General Hospital Of Ioannina	Ioannina	Greece
Centre Hospitalier Universitaire De Nice	Nice	France
University General Hospital Of Alexandroupoli	Alexandroupoli	Greece
Kliniken der Stadt Koeln gGmbH	Cologne	Germany
Hopitaux Prives De Metz	Vantoux	France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Matrai Gyogyintezet	Gyongyos	Hungary
Semmelweis University	Budapest	Hungary
Assistance Publique Hopitaux De Paris	Paris	France
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Zentralklinik Bad Berka GmbH	Bad Berka	Germany
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH	Essen	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Hospital Universitario Puerta Del Mar	Cadiz	Spain
Geniko Nosokomeio Thessalonikis George Papanikolaou	Thessaloniki	Greece
University General Hospital Of Heraklion	Heraklion	Greece
IKF Pneumologie GmbH & Co. KG	Frankfurt	Germany
Assistance Publique Hopitaux De Paris	Creteil	France
Thoracic General Hospital Of Athens I Sotiria	Athens	Greece
Aktayzvtmu Pogjvnsx Hralkulo Dr Mopxvdbmz	Marseille	France
Affumtq Ohtdzyanpmf Ueewsswninucq Susjvc	Siena	Italy
Gifijk Uhwxyarmog Fksuebeyn	Frankfurt	Germany
Mbexlzzgdlabnaxxucpjqmjxlg Hrhermanktzyuefr	Halle (Saale)	Germany

Trial status

Country	Status	Recruitment Start
France	Not recruiting	02.10.2023
Germany	Not recruiting	02.10.2023
Greece	Not recruiting	02.10.2023
Hungary	Not recruiting	02.10.2023
Italy	Not recruiting	02.10.2023
Spain	Not recruiting	02.10.2023

Trial locations

Investigated drugs:

Mbs2320

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.

Investigated diseases:

Idiopathic pulmonary fibrosis

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.

Trial ID:

2023-504418-30-00

Protocol code:

IST-07

Trial Phase:

Therapeutic exploratory (Phase II)

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

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