Study on Vixarelimab for Patients with Idiopathic Pulmonary Fibrosis and Systemic Sclerosis-Associated Interstitial Lung Disease

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What is this study about?

This clinical trial is focused on studying two lung-related diseases: Idiopathic Pulmonary Fibrosis and Systemic Sclerosis-Associated Interstitial Lung Disease. The treatment being tested is called Vixarelimab, which is given as a solution for injection. The study will compare the effects of Vixarelimab with a placebo to understand its impact on lung function in patients with these conditions.

The purpose of the study is to evaluate how well Vixarelimab works in improving lung function. Participants will receive either Vixarelimab or a placebo through subcutaneous injection, which means the injection is given under the skin. The study will last for a period of up to 104 weeks, during which various health assessments will be conducted to monitor changes in lung function and overall health.

Throughout the study, participants will undergo regular check-ups to measure changes in their lung capacity and other health indicators. The study aims to provide valuable information on the safety and effectiveness of Vixarelimab in treating these lung diseases, potentially leading to better treatment options in the future.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed through various tests, including lung function tests and a 6-minute walk test. These tests help determine your current health status and ensure you meet the study criteria.

2 randomization

After confirming eligibility, you will be randomly assigned to one of two groups. One group will receive the study medication, vixarelimab, and the other will receive a placebo, which looks like the medication but does not contain the active ingredient. This process is called randomization and ensures that the study results are unbiased.

3 medication administration

You will receive the assigned treatment as a subcutaneous injection, which means the medication is injected under the skin. The exact dosage and frequency will be explained to you by the study team. This treatment will continue for a specified duration, up to 52 weeks.

4 regular follow-up visits

Throughout the study, you will have regular follow-up visits. During these visits, your health will be monitored through various assessments, including lung function tests, walk tests, and questionnaires about your quality of life and symptoms. These visits help track your progress and any changes in your condition.

5 end of treatment

At the end of the treatment period, you will have a final visit. This visit will include a comprehensive evaluation of your health and any changes since the start of the study. The study team will discuss the next steps with you, including any follow-up care that may be needed.

Who Can Join the Study?

  • Must have a forced vital capacity (FVC) of at least 45% of what is predicted for a healthy person. FVC is a test that measures how much air you can exhale after taking a deep breath.
  • Must have a FEV1/FVC ratio greater than 0.70. This ratio compares the amount of air you can forcefully exhale in one second (FEV1) to the total amount you can exhale (FVC).
  • Must have a diffusion capacity of the lung for carbon monoxide (DLCO) between 30% and 90% of what is predicted for a healthy person. DLCO measures how well your lungs can transfer gas from the air you breathe to your blood.
  • Must be able to walk at least 150 meters in a 6-minute walk test (6MWT) while using a maximum of 6 liters per minute of supplemental oxygen at sea level, or up to 8 liters per minute at higher altitudes, and maintain an oxygen saturation of more than 83% during the test.
  • For Cohort 1: Must have a documented diagnosis of idiopathic pulmonary fibrosis (IPF) or a likely diagnosis of IPF according to specific medical guidelines or a high-resolution CT scan pattern that matches IPF.
  • For Cohort 2: Must have a diagnosis of systemic sclerosis (SSc) as defined by specific medical criteria.
  • Must be within the age range of adults and older adults.
  • Both male and female participants are eligible.
  • Participants from vulnerable populations are eligible.

Who Cannot Join the Study?

  • Patients with any other lung disease besides Idiopathic Pulmonary Fibrosis or Systemic Sclerosis-Associated Interstitial Lung Disease cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients with a history of severe allergic reactions to any medication cannot participate.
  • Patients with uncontrolled medical conditions that could interfere with the study cannot participate.
  • Patients who are unable to comply with the study procedures and visits cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Koranyi National Institute For Pulmonology Budapest Hungary
Hospital Clinico San Carlos Madrid Spain
Azienda Ospedaliero Universitaria Careggi Florence Italy
Katholieke Universiteit te Leuven Leuven Belgium
Bellvitge University Hospital L'hospitalet De Llobregat Spain

Other Sites

Site Name City Country Status
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
General University Hospital Of Larissa Larissa Greece
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland
Centre Hospitalier Universitaire De Nice Nice France
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Hôpital Avicenne Bobigny France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospices Civils De Lyon Lyon France
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Centre hospitalier universitaire de Liege Liege Belgium
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH Essen Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Servei De Salut De Les Illes Balears Palma Spain
University General Hospital Of Heraklion Heraklion Greece
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Berlin Germany
Multimedica S.p.A. Milan Italy
Hospital Universitario Virgen De La Victoria Malaga Spain
Ospedale “Morgagni – Pierantoni” di Forlì Forli' Italy
Cocfbo Hlfetinjllo Ueyrlsfiqhqiq Rxvab Reims France
Peknyy Gysndtlg Glokkb Mwvrgri Knhylmrk sgrf Sosnowiec Poland
Amawvkhjrs Pcthsbad Hopsxegr Dd Meqgmanmy Marseille France
Ucvefqifxxicudanrzirp Dqdmssvtgva Apd Duesseldorf Germany
Aaycyrh Olkecbfypuw Uxdxmuwnlypcc Svagrf Siena Italy
Afphibp Orqktuidshn Ujmevzkcbplbr Czenzzrxfqoo Dzron Sthric E Djdtj Splgiht Dc Tfcytw Turin Italy
Atcdlxi Uyk Iycas Du Rcissm Eicqsd Reggio Emilia Italy
Hevifnrs Uvjfllhgnwsrd Mifypho Dy Voxiolgggw Santander Spain
Ovmnaswhuzoltkcjyauiyeqjei Aalst Belgium
Exya Cloflsh Ujnyt Mqlejdnjit Ers Śsueira Rzeszow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
25.11.2023
France France
Not recruiting
25.11.2023
Germany Germany
Not recruiting
25.11.2023
Greece Greece
Not recruiting
25.11.2023
Hungary Hungary
Not recruiting
25.11.2023
Italy Italy
Not recruiting
25.11.2023
Poland Poland
Not recruiting
25.11.2023
Spain Spain
Not recruiting
25.11.2023

Trial locations

Investigated drugs:

Vixarelimab is a medication being studied for its potential to help people with lung conditions. In this trial, researchers are looking at how well it works for two specific lung problems: idiopathic pulmonary fibrosis and systemic sclerosis-associated interstitial lung disease. These are conditions where the lungs become scarred and stiff, making it hard to breathe. Vixarelimab is being tested to see if it can improve lung function, which means helping the lungs work better and making it easier for patients to breathe. The study is comparing Vixarelimab to a placebo to see if it really makes a difference in the patients’ lung health.

Idiopathic Pulmonary Fibrosis – Idiopathic Pulmonary Fibrosis is a chronic lung disease characterized by the progressive scarring of lung tissue. This scarring, or fibrosis, leads to a gradual decline in lung function, making it increasingly difficult for the lungs to transport oxygen into the bloodstream. The disease typically begins with symptoms such as shortness of breath and a persistent dry cough. Over time, the scarring worsens, leading to more severe breathing difficulties and reduced exercise tolerance. The exact cause of the fibrosis is unknown, which is why it is termed “idiopathic.” The progression of the disease varies among individuals, with some experiencing a rapid decline in lung function.

Systemic Sclerosis-Associated Interstitial Lung Disease – Systemic Sclerosis-Associated Interstitial Lung Disease is a condition where the connective tissue disease systemic sclerosis affects the lungs, leading to inflammation and scarring of lung tissue. This interstitial lung disease results in the thickening and stiffening of the lung tissue, which impairs the lungs’ ability to function properly. Patients may experience symptoms such as shortness of breath, a persistent cough, and fatigue. As the disease progresses, lung function continues to decline, leading to increased respiratory difficulties. The extent and rate of progression can vary significantly among individuals. The lung involvement is a significant aspect of systemic sclerosis, impacting overall health and quality of life.

Trial ID:
2022-502828-42-00
Protocol code:
GB44496
Trial Phase:
Therapeutic exploratory (Phase II)

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