Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Two-Cohort, Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of Vixarelimab Compared with Placebo in Patients with Idiopathic Pulmonary Fibrosis and in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease

This research study is looking at a new drug called Vixarelimab for two serious lung diseases: Idiopathic Pulmonary Fibrosis (IPF) and Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD). Both conditions cause scarring in the lungs, making it hard to breathe. The study wants to find out if Vixarelimab is better than a placebo (a dummy drug with no active ingredients) at improving how well the lungs work. Researchers will also check for any side effects and how the medicine affects patients' quality of life, cough, and shortness of breath. This is a Phase II study, meaning it's still in the early stages of testing, after initial safety checks have been done.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Genentech Inc.

Enrolment target

134

Start

01 Aug 2023

Idiopathic Pulmonary Fibrosis, Systemic Sclerosis-Associated Interstitial Lung Disease

What is this study about?

This study is about finding better ways to treat two lung conditions: Idiopathic Pulmonary Fibrosis (IPF) and Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD). In both conditions, the lungs become scarred and stiff, which makes it harder to breathe and get enough oxygen. There isn't a cure for these conditions yet, so doctors are always looking for new treatments to slow down the disease or make symptoms better.

The new medicine being tested is called Vixarelimab. Researchers believe it might help reduce the scarring in the lungs. To find out if it works, some people in the study will receive Vixarelimab, and others will receive a placebo. A placebo looks just like the real medicine but contains no active drug. This is a common way to test new treatments fairly, as it helps doctors see if any improvements are truly due to the new medicine or something else.

The main thing the doctors want to measure is how much the patient's lung function improves, specifically looking at how much air they can breathe out forcefully after taking a deep breath. They will also look at other important things like how far people can walk in six minutes, how their quality of life changes, if their cough or breathlessness gets better, and if there are any side effects. The study will last about a year, and observations will be made throughout this period.

Key takeaways

This study is testing a new drug for lung scarring conditions.
It aims to see if Vixarelimab improves lung function over a year.
Some patients will get the active drug, others a dummy drug (placebo).
Close monitoring for lung changes and side effects will happen.
The study involves regular clinic visits and various health assessments.

Who may be eligible?

To join this study, you need to be at least 18 years old. Both men and women can take part. Because this study is looking at specific conditions, you would need to have received a diagnosis of either Idiopathic Pulmonary Fibrosis (IPF) or Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD).

There might be other medical checks and criteria that determine if you are suitable for the study. These are put in place to ensure your safety and that the study results are as clear and accurate as possible. For example, certain other health problems or medications might prevent you from joining.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with Idiopathic Pulmonary Fibrosis (IPF)?
OR have you been diagnosed with Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)?
Are you able to attend regular clinic appointments for about a year?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive either the new medicine, Vixarelimab, or a placebo, which looks identical but contains no active drug. Neither you nor your study doctor would know which one you are receiving – this is called a 'double-blind' study. You would have regular visits to the clinic over about a year (52 weeks).

During these visits, doctors would perform various tests to check your lung function, such as measuring how much air you can breathe out. They would also do walking tests, blood tests, and scans of your lungs. You would also be asked to answer questionnaires about your symptoms, quality of life, cough, and how breathless you are feeling. Throughout the study, medical staff would closely monitor you for any side effects or changes to your health. You have the right to withdraw from the study at any time.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving a new treatment that might improve your condition, closer monitoring of your health than usual, and contributing to medical knowledge that could help others in the future. However, there are also potential risks; Vixarelimab is still being tested, and not all side effects are fully known. You might also receive the placebo and not the active drug. Participation involves frequent hospital visits and tests, which can be time-consuming. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany
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Unverified
Hungary
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Unverified
Italy
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Unverified
France
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Unverified
Poland
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Unverified
Belgium
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Unverified
Greece
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Unverified
Spain

Common questions

What is Idiopathic Pulmonary Fibrosis?

It's a serious lung disease where scar tissue builds up in the lungs, making them stiff and difficult to breathe. 'Idiopathic' means the cause is unknown.

What is Systemic Sclerosis-Associated Interstitial Lung Disease?

This is a lung condition that can happen in people with systemic sclerosis (scleroderma), an illness causing hardening of the skin and other organs, including the lungs.

What does 'placebo' mean?

A placebo is a dummy treatment that looks exactly like the real medicine but doesn't contain any active drug. It helps doctors see if the real medicine is truly making a difference.

What is being measured in this study?

The main thing is how much air your lungs can hold and breathe out (FVC). Doctors will also check walking ability, quality of life, cough, breathlessness, and side effects.

How long will I be in the study?

The main part of the study involves receiving treatment and being monitored for about 52 weeks, which is roughly one year.