A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD)
Systemic sclerosis, often called scleroderma, is a rare condition where the body's immune system attacks healthy tissue. In some people, this causes scarring in the lungs, known as interstitial lung disease (ILD). This lung damage can lead to breathlessness, persistent coughs, and tiredness. This Phase 2 clinical trial looks at a new experimental medicine called tulisokibart (also known as PRA023). Doctors want to find out if tulisokibart can safely slow down lung scarring and help protect breathing capacity. Over 50 weeks, participants will receive either the study medicine or a dummy treatment (placebo) through a drip into a vein. Doctors will carefully track lung health, chest scans, and everyday wellbeing. Taking part is voluntary, and participants receive close medical care from lung and scleroderma specialists throughout the study.
At a glance
What is this study about?
Systemic sclerosis is an autoimmune condition that causes the body to produce too much collagen, leading to hardening of the skin and internal organs. When this affects the lungs, it is known as systemic sclerosis-associated interstitial lung disease (SSc-ILD). The delicate tissue of the lungs becomes inflamed and scarred, making it harder for oxygen to pass into the blood. Everyday activities like walking up stairs can become exhausting, and current treatment options are limited.
This clinical trial is testing an experimental medicine called tulisokibart (or PRA023). Tulisokibart is designed to block certain signals in the body that cause inflammation and tissue scarring. Researchers hope that by calming these signals, the medicine will help protect the lungs from further damage and allow people to maintain their lung capacity for longer.
The trial is 'placebo-controlled' and 'double-blind'. This means half of the volunteers will receive tulisokibart, while the other half will receive a harmless salt-water drip (placebo). Neither the patients nor their doctors will know who is receiving which treatment until the trial is over. This is the gold standard way to test if improvements are truly caused by the new medicine.
Finding new ways to treat lung scarring in scleroderma is vital. If successful, this trial could lead to new therapies that slow down the disease, reduce symptoms, and help people live more active, comfortable lives.
Key takeaways
- Tests a new medicine (tulisokibart) to treat lung scarring in people with scleroderma.
- Aims to slow down lung damage and help protect everyday breathing capacity.
- Lasts around 50 weeks and involves regular hospital visits for drips and check-ups.
- Half of the participants receive the study drug and half receive a dummy drip (placebo).
- Participation is entirely voluntary, and you can leave at any time.
Who may be eligible?
This study is open to adults aged 18 and over who have been diagnosed with systemic sclerosis that affects their lungs. Both men and women can join.
To be considered, participants must have evidence of lung scarring (interstitial lung disease) and be able to complete regular breathing tests and attend hospital appointments. A specialist doctor will review your medical history and run tests to ensure it is safe for you to take part.
You may not be eligible if you have other serious lung conditions not related to scleroderma, severe heart problems, or active infections. Women who are pregnant or breastfeeding are usually unable to join for safety reasons. The research team will also check all your current medications to make sure they do not clash with the trial medicine.
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.
- I am aged 18 or older.
- I have been diagnosed with systemic sclerosis (scleroderma).
- I have known lung scarring or lung involvement (interstitial lung disease).
- I am willing and able to attend regular hospital appointments for infusions and tests over 50 weeks.
- I am not currently pregnant or planning to become pregnant during the study.
What does participation involve?
If you join the trial, your participation will last for about 50 weeks. You will receive your allocated treatment (either tulisokibart or the placebo) through a drip into a vein (an intravenous infusion) at the hospital clinic. Throughout the study, you will have regular clinic visits so doctors can check on your health. These visits will involve breathing tests (blowing into a machine to check lung capacity), chest CT scans, blood and urine tests, and physical examinations. You will also be asked to fill out simple questionnaires about your daily energy levels, breathlessness, and overall quality of life. The study team will support you throughout and answer any questions you have.
Potential risks and benefits
Locations (8)
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedPoland
- —UnverifiedNetherlands
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedBelgium
Common questions
What is a placebo and why is it used?
A placebo is a harmless dummy treatment, in this case a simple salt-water drip. It looks identical to the real medicine. It helps scientists see whether any health changes are genuinely caused by the new drug or would have happened anyway.
Will I have to pay to take part in this study?
No. The trial medication, clinic visits, and all study-related tests are provided free of charge. In many trials, reasonable travel expenses are also reimbursed.
Can I continue taking my regular scleroderma medications?
Many participants can continue taking certain standard medications, but some drugs may not be allowed. The study doctor will review all your current treatments to make sure they are safe to use during the trial.
What happens if my breathing gets worse during the trial?
Your safety is the top priority. Your lung health will be monitored closely. If your condition worsens, the study doctors will provide appropriate medical treatment, which may include stopping the trial medicine.
Can I leave the study early if I change my mind?
Yes. You have the right to leave the trial at any point, for any reason. Doing so will not affect your relationship with your healthcare team or your normal medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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