Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

SCLERITA - Safety and efficacy of itacitinib in adults with systemic sclerosis: a phase II, randomized, controlled trial

The SCLERITA study is looking into a new treatment, itacitinib, for adults who have recently been diagnosed with or currently have active systemic sclerosis, also known as scleroderma. This is a phase II trial, which means researchers are carefully checking if the new medicine is safe and if it works to help patients. Participants will receive either the new medicine or a placebo (a dummy pill with no active ingredient). We will be carefully monitoring changes in skin condition over a year, as well as looking at how patients feel, their quality of life, and any side effects. This research aims to find better ways to manage systemic sclerosis and improve the lives of those affected.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

30 Jul 2024

Patients with newly or active diffuse Systemic sclerosis (SSc) at the time of screening

What is this study about?

This research study, called SCLERITA, is designed to investigate a new medication named itacitinib. The study focuses on adults who have systemic sclerosis, often called scleroderma. Scleroderma is a long-term condition that affects the body's connective tissues, which support organs and other parts of the body. In this study, we're particularly interested in people whose scleroderma is new or currently active, especially when it causes skin changes.

The main goal of the SCLERITA study is to see how safe itacitinib is and if it can help improve the skin of people with scleroderma over approximately one year. Researchers will measure changes in skin thickness and hardness using a special score called the modified Rodnan skin score. This helps us understand if the new medicine is making a positive difference. We will also be closely watching for any side effects and how the medicine affects a person's general health and well-being.

This is a 'Phase II' study, which means it’s an early but important step in developing new medicines. In this phase, we look closely at how safe the drug is and if there are signs that it might be an effective treatment. Participants will be randomly assigned to receive either the active medicine (itacitinib) or a placebo (a pill that looks the same but contains no medicine). This is a standard way to ensure we can accurately tell if any changes are due to the medicine itself. By participating, you could help us learn valuable information that might lead to better treatments for scleroderma in the future.

Key takeaways

The SCLERITA study is testing a new medicine, itacitinib, for scleroderma.
It aims to see if the medicine is safe and improves skin condition.
Participants will receive either itacitinib or a dummy pill.
The study lasts about one year with regular check-ups.
It's for adults (18+) with new or active scleroderma.
Your participation could help improve future scleroderma treatments.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older.

The study is specifically looking for people who have been diagnosed with systemic sclerosis (scleroderma) that is either quite new or is currently active. This means your condition should be showing signs of activity or have been diagnosed recently at the time you are being screened for the study.

Both men and women are welcome to take part in this research.

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 systemic sclerosis (scleroderma)?
Is your scleroderma considered 'active' or was it recently diagnosed?
Are you a man or a woman?

Answer every question to see your result.

What does participation involve?

If you decide to join the SCLERITA study, you will have regular visits to the clinic or hospital over roughly a year. At these visits, doctors and nurses will carry out various checks, such as physical exams, blood tests, and assessments of your skin. You'll also be asked to answer questionnaires about your daily life and how you're feeling. You will be given either the study medicine, itacitinib, or a dummy pill (placebo) to take regularly, as instructed by the study team. Both you and the study team won’t know whether you’re receiving the active drug or the placebo until the end of the study. After the main treatment period, there will be follow-up appointments to check on your health. The total duration of your involvement in the study will be around 12 months.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving close medical attention and potentially benefiting from a new treatment for your scleroderma. However, there's no guarantee that the treatment will work for you, and some people will receive a placebo. Like all medicines, itacitinib may have side effects, which the study team will monitor very carefully. All study procedures carry some risks, which will be fully explained to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What is systemic sclerosis (scleroderma)?

Scleroderma is a long-term condition that causes the body's immune system to attack its own tissues. This can lead to thickening and scarring of the skin, and sometimes affect internal organs.

What is itacitinib?

Itacitinib is a new medicine being tested. It works by targeting certain pathways in the body that are thought to be involved in conditions like scleroderma.

What is a 'dummy pill' or placebo?

A dummy pill (placebo) looks exactly like the study medicine but doesn't contain any active drug. It's used in studies to fairly compare the new medicine's effects.

Will I know if I'm getting the actual medicine or the dummy pill?

In this study, neither you nor the study doctors will know whether you are receiving the active medicine or the dummy pill until after the study has finished. This helps to make the study results as fair and unbiased as possible.

How long will the study last?

Your involvement in the study will last for approximately one year, including regular visits and follow-up checks.