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

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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 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.

The research process

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

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

9 criteria

  • 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 trial?

7 criteria

  • 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.
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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.

What is already known about the treatment

Vixarelimab – Vixarelimab is administered as an injection, typically under the skin, and is currently being studied in clinical trials for its potential benefits in treating lung diseases. It is being evaluated for its effectiveness in improving lung function in patients with Idiopathic Pulmonary Fibrosis and Systemic Sclerosis-Associated Interstitial Lung Disease. The medication works by targeting specific proteins in the body that are involved in inflammation and tissue damage, helping to reduce these harmful effects. Vixarelimab is classified as an immunomodulatory agent, which means it helps to regulate the immune system's response.

Investigated diseases

  • 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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502828-42-00Protocol codeGB44496Estimated enrolment330 patientsSponsorGenentech Inc.

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