Study on the Effects of CAL101 for Patients with Idiopathic Pulmonary Fibrosis

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What is this study about?

This clinical trial is focused on studying a lung disease called Idiopathic Pulmonary Fibrosis (IPF). IPF is a condition where the lungs become scarred and breathing becomes difficult over time. The study will test a treatment called CAL101, which is given as a solution through a vein, a method known as intravenous use. The treatment aims to see if CAL101 can help improve lung function in people with IPF.

The purpose of the study is to evaluate how effective and safe CAL101 is for patients with IPF. Participants in the study will receive either CAL101 or a placebo, which is a substance with no active medication. The study will last for about 28 weeks, during which the lung function of participants will be closely monitored to see if there are any improvements. The main focus will be on changes in the amount of air the lungs can hold, known as forced vital capacity (FVC).

Throughout the study, participants will be observed for any side effects or adverse events. The study will also track how many participants experience these events over a period of 40 weeks. This research is important to understand if CAL101 can be a beneficial treatment option for those living with IPF.

1 enrollment and initial assessment

Upon joining the study, you will undergo an initial assessment to confirm your eligibility. This includes reviewing your medical history and conducting tests to ensure you meet the study criteria, such as being 40 years or older and having a diagnosis of idiopathic pulmonary fibrosis (IPF).

A high-resolution computed tomography (HRCT) scan of your chest will be reviewed to confirm the pattern of lung disease. Your lung function will be measured, including forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLCO).

2 randomization and treatment assignment

You will be randomly assigned to receive either the study medication, CAL101, or a placebo. This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.

The treatment will be administered intravenously, which means it will be given through a vein. You will receive the treatment regularly over a period of 28 weeks.

3 treatment phase

During the 28-week treatment phase, you will receive the intravenous infusion of CAL101 or placebo. The frequency and exact schedule of these infusions will be explained to you by the study team.

You will continue any stable dose of antifibrotic medication, such as nintedanib or pirfenidone, if you were already taking it before the study, unless advised otherwise by the study team.

4 regular monitoring and assessments

Throughout the study, your health and lung function will be closely monitored. This includes regular visits to the study site for assessments and tests to measure changes in your lung function, particularly the FVC.

You will be asked to report any side effects or adverse events you experience during the study. This monitoring will continue for up to 40 weeks to ensure your safety and to gather comprehensive data.

5 end of treatment and follow-up

At the end of the 28-week treatment period, you will undergo a final assessment to evaluate the effects of the treatment on your lung function and overall health.

You may be asked to return for follow-up visits to monitor your health and any long-term effects of the treatment. The study team will provide you with detailed instructions on these follow-up procedures.

Who Can Join the Study?

Must be 40 years of age or older at the time of giving consent to participate.
Must have a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) according to current international guidelines.
Must have a definite or probable pattern of usual interstitial pneumonia (UIP) on a chest scan called high-resolution computed tomography (HRCT) done within the last 12 months, confirmed by a central review. If a recent HRCT is not available, a new one will be used to check eligibility.
Must have a forced vital capacity (FVC) of at least 45% of what is predicted for a person of similar characteristics. FVC is a measure of lung function that shows how much air you can exhale after taking a deep breath.
Must have a Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) of at least 25% of what is predicted, corrected for hemoglobin levels. DLCO measures how well the lungs can transfer oxygen into the blood.
Must have a ratio of forced expiratory volume in 1 second (FEV1) to FVC of at least 0.7. This ratio helps assess lung function.
Must either be on a stable dose of antifibrotic medication (such as nintedanib or pirfenidone) for at least 8 weeks before screening or not have been treated with antifibrotics for at least 8 weeks before screening. If on antifibrotic medication, it is expected that the patient will continue it throughout the trial.

Who Cannot Join the Study?

Patients who do not have Idiopathic Pulmonary Fibrosis (IPF) cannot participate. IPF is a lung disease that causes scarring of the lungs for an unknown reason.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Oslo Universitetssykehus HF	Oslo	Norway
Hôpital Européen Georges-Pompidou	Paris	France
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Hôpital Avicenne	Bobigny	France
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Nordlandssykehuset HF	Bodo	Norway
Spitalul Clinic De Pneumoftiziologie Leon Daniello	Cluj Napoca	Romania
Azienda Ospedaliera di Padova	Padua	Italy
Hospital of Infectious Diseases and Pneumology Victor Babes, Timisoara	Timisoara	Romania
Odense University Hospital	Odense	Denmark
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Institutul De Pneumoftiziologie Marius Nasta	Bucharest	Romania
Roskilde University	Roskilde	Denmark
Hôpital Pontchaillou-CHU Rennes	Rennes	France
Hizvjzbz Uvhbtshscoyoz Mtpzxer Dg Vrfxghwknt	Santander	Spain
Ajlilcmx Ubvalebiun Hlegucwt	Lorenskog	Norway
Hdnbt Bunuqz Hy	Bergen	Norway
Eqogrfw Ungudnwysbdw Mxkcjdz Cvdxuru Rdhlzciyv (isfceqh Mtt	Rotterdam	The Netherlands
Aztvsyb Ozubfkrucba Uecvgxvaetbqs Swjzyj	Siena	Italy
Apfdvm Uuibswiclq Hbahneta	Aarhus	Denmark
Caayqv Hdwzgcqlvdy Rqjjymrv Uxbzrijvvynkh Dj Trmpy	Tours	France
Huxaxbdo Dn Le Sqdng Cygi I Sewq Pgp	Barcelona	Spain
Htmtqphz Vykd dkxluwud	Barcelona	Spain
Sherbftj Cqioxa Dt Bykd Icueecuumyy Sf Phldkmqfpmdgiroqw Vjzjmy Bopxd Czjsdih	Craiova	Romania

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	02.06.2025
France	Not recruiting	02.06.2025
Italy	Not recruiting	02.06.2025
Norway	Not recruiting	02.06.2025
Romania	Not recruiting	02.06.2025
Spain	Not recruiting	02.06.2025
The Netherlands	Not recruiting	02.06.2025

Trial locations

Investigated drugs:

CAL101 is a medication being tested in this clinical trial for its potential to help people with idiopathic pulmonary fibrosis, a lung disease that makes it hard to breathe. The trial is looking at how well CAL101 works when given through an IV, which means it is delivered directly into the bloodstream. The main goal is to see if CAL101 can improve lung function by measuring changes in how much air a person can exhale after taking a deep breath, known as forced vital capacity. This study will compare the effects of CAL101 to a placebo over a period of 28 weeks to see if it can help improve breathing in patients with this condition.

Investigated diseases:

Idiopathic pulmonary fibrosis

Idiopathic Pulmonary Fibrosis – Idiopathic Pulmonary Fibrosis is a chronic lung disease characterized by the thickening and scarring of lung tissue. This scarring, known as fibrosis, leads to a progressive decline in lung function. The disease typically begins with shortness of breath and a persistent dry cough. As it progresses, patients may experience fatigue, unexplained weight loss, and clubbing of the fingers. Over time, the scarring makes it increasingly difficult for the lungs to transfer oxygen into the bloodstream. The exact cause of the fibrosis is unknown, which is why it is termed “idiopathic.”

Trial ID:

2024-518339-12-00

Protocol code:

CAL101-201

NCT ID:

NCT06736990

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of CAL101 for Patients with Idiopathic Pulmonary Fibrosis

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