Active not recruitingPHASE2INTERVENTIONAL

Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)

This study is investigating a new medication called tulisokibart for individuals living with systemic sclerosis (scleroderma) and an associated lung condition known as interstitial lung disease (ILD). Scleroderma is a rare disease that can affect the skin and internal organs, and ILD causes scarring in the lungs, making it harder to breathe. The main goals of this research are to find out if tulisokibart is safe to use and if it can effectively help manage the symptoms and progression of SSc-ILD. Participants will be carefully monitored, and the study will involve different groups, including some receiving the new drug and others receiving a placebo (a dummy drug). This is a 'Phase 2' study, meaning we're still in the early stages of testing this new treatment.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Enrolment target

154

Start

29 Mar 2022

Estimated completion

31 Jul 2029

Diffuse Cutaneous Systemic Sclerosis Interstitial Lung Disease

What is this study about?

This research study is about a condition called Systemic Sclerosis-associated Interstitial Lung Disease, often shortened to SSc-ILD. Let's break that down: Systemic Sclerosis (SSc) is a long-term condition that causes the body's immune system to attack its own tissues. This can lead to thickening of the skin and damage to internal organs, including the lungs. When it affects the lungs in a specific way, it's called Interstitial Lung Disease (ILD). ILD means there's inflammation and scarring in the tiny air sacs of the lungs, which can make it harder to breathe and lead to a persistent cough.

The study is testing a new drug called tulisokibart. Researchers want to understand if this drug can help people with SSc-ILD. They're looking at two main things: "safety," which means checking if the drug has any unwanted side effects and if it's generally well-tolerated, and "efficacy," which means finding out if the drug actually helps to improve the lung condition or slow down its progression. This is an important step because new treatments are always being explored to help manage challenging conditions like SSc-ILD.

This study is in "Phase 2" of clinical development. This means the drug has already been tested in a small number of people and shown some promise, but now a larger group of people are needed to get more information about its effects. Discovering new and effective treatments for conditions like SSc-ILD could make a significant difference to patients' quality of life, which is why studies like this are so crucial.

Key takeaways

This study is testing a new drug for lung problems linked to scleroderma.
It's a 'Phase 2' study, looking at both safety and how well the drug works.
Participation involves regular clinic visits and tests.
Some people will get the new drug, others a dummy drug (placebo).
You can stop participating at any time if you wish.

Who may be eligible?

To join this study, you would need to have a confirmed diagnosis of systemic sclerosis (scleroderma) that started within the last five years. You must also have the 'diffuse cutaneous' type, which means the skin thickening affects larger areas, and have lung problems (interstitial lung disease) linked to your scleroderma. This lung condition must be confirmed by a special scan called a HRCT.

There are also some requirements about your lung function: your breathing tests (FVC and DLCO) need to be at least 45% of what's expected for someone of your age and size. If you're already taking other medicines for your condition, such as nintedanib or mycophenolate mofetil, they need to have been on a stable dose. Women who could become pregnant might be able to participate if they are not pregnant or breastfeeding, and they agree to use effective birth control or avoid sex.

Some things would mean you couldn't take part. For example, if you have airflow problems in your lungs or high blood pressure in your lungs, if you have other serious inflammatory conditions, or if you've had a serious infection recently. Current smokers, or those who have smoked in the last six months, also can't join. The study team will check your medical history and blood tests carefully to make sure it's safe for you to participate.

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.

Have you been diagnosed with systemic sclerosis (scleroderma)?
Did your scleroderma diagnosis happen within the last 5 years?
Do you have the 'diffuse cutaneous' type of scleroderma?
Do you also have interstitial lung disease (ILD) linked to your scleroderma?
Are you able to attend appointments and follow study instructions?
Are you 18 years old or older?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will likely need to make regular visits to the clinic for check-ups. These visits will involve various tests and assessments, such as breathing tests, blood samples, and physical examinations. You will be given the study medication, tulisokibart, or a placebo (a dummy drug that looks like the real thing but has no active ingredient). You won't know which one you are receiving. The study team will explain exactly how to take the medication.

Throughout the study, your health will be carefully monitored by the medical team. This includes watching for any side effects and seeing how your condition responds to the treatment. There will be a follow-up period after you stop taking the study medication to ensure your well-being. The total duration of your participation in the study will be explained in detail by the study team, including how long you will receive the medication and how long the follow-up period will last.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as access to a new experimental treatment that isn't yet available, and close medical monitoring of your condition. However, there are also potential risks involved. The study drug, tulisokibart, is still being tested, so its full range of side effects isn't completely known. You might experience side effects from the drug, or the treatment might not help your condition. There's also a chance you could receive the placebo and experience no active treatment effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (95)

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

Mayo Clinic - Scottsdale ( Site 4014)
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Phoenix, United States
Pacific Arthritis Care Center ( Site 4008)
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Los Angeles, United States
Cedars Sinai Medical Center ( Site 4010)
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Los Angeles, United States
UCLA School of Medicine ( Site 4006)
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Los Angeles, United States
Stanford Health Care ( Site 4009)
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Palo Alto, United States
National Jewish Health Medical Center ( Site 4015)
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Denver, United States
Yale University ( Site 4017)
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New Haven, United States
MedStar Georgetown University Hospital ( Site 4005)
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Washington D.C., United States
Johns Hopkins Asthma and Allergy Center [Baltimore, MD] ( Site 4018)
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Baltimore, United States
Massachusetts General Hospital ( Site 4003)
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Boston, United States
Boston University School of Medicine ( Site 4021)
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Boston, United States
University of Michigan Hospital ( Site 4001)
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Ann Arbor, United States

Common questions

What is systemic sclerosis and ILD?

Systemic sclerosis (scleroderma) is a condition where your immune system attacks your own body, causing skin hardening and sometimes affecting organs like your lungs. ILD is when this causes scarring and breathing problems in the lungs.

What is a 'Phase 2' study?

Phase 2 means the drug is still quite new. It has been tested for safety in a small group and now needs to be tested in a larger group of people to see if it works and to learn more about its safety.

What is a 'placebo'?

A placebo is a dummy drug that looks exactly like the real medication but doesn't contain any active ingredients. It helps researchers understand if the new drug is truly making a difference.

Will I know if I'm getting the drug or the placebo?

No, this is usually a 'blinded' study, meaning neither you nor your study doctor will know if you are receiving the active drug or the placebo. This helps make the study results more reliable.

Can I stop participating in the study if I want to?

Yes, you are free to leave the study at any time, for any reason, without it affecting your ongoing medical care.