Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, ADD-ON TRIAL EVALUATING EFFICACY AND SAFETY OF HYDROXYCHLOROQUINE IN EARLY SYSTEMIC SCLEROSIS (SSc)- HYDROXYSSc

This study, called HYDROXYSSc, is a Phase 3 clinical trial investigating a medication called hydroxychloroquine (also known as Plaquenil) for people with early systemic sclerosis. Systemic sclerosis is a rare condition affecting the immune system, blood vessels, and skin. The aim is to see if adding hydroxychloroquine to current treatments is effective and safe compared to taking a dummy pill (placebo). Neither the participants nor their doctors will know who is getting the active drug and who is getting the placebo. Researchers will compare changes in symptoms and overall well-being over 52 weeks using established medical scoring systems.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Enrolment target

151

Start

12 Aug 2024

Systemic Sclerosis (SSc) is a rare and orphan disease (DPCM 12 gennaio 2017-GU SG n°65-S.O. n°15 - 18/03/2017)characterized by immunological

What is this study about?

Systemic sclerosis is a rare, long-lasting condition that affects the body's immune system, blood vessels, and can lead to hardening of the skin and other parts of the body. It's not very common, affecting about 100 to 300 people out of every million. Although rare, it can have a big impact on people's lives.

This study, called HYDROXYSSc, is a Phase 3 clinical trial. This means it's an important stage of research where doctors are trying to confirm if a new treatment is effective and safe before it might be widely used. The main goal is to find out if adding a medication called hydroxychloroquine (also known by its brand name, Plaquenil) to a person's current treatment helps improve their condition more than receiving a dummy pill (placebo).

The study is 'double-blind' and 'randomized'. This means participants will be randomly assigned to either receive hydroxychloroquine or a placebo, and neither they nor their doctors will know which one they are getting. This approach helps ensure the results are as fair and unbiased as possible. Over 52 weeks (about a year), doctors will carefully compare how participants in both groups feel and how their condition changes, using special measures to track progress.

Key takeaways

This study is testing a known drug, hydroxychloroquine, for early systemic sclerosis.
It's a large-scale study (Phase 3) to confirm if the drug is effective and safe.
Participants will be randomly assigned to receive either the drug or a placebo (dummy pill).
The study lasts for 52 weeks, with regular check-ups.
It aims to improve symptoms like pain, stiffness, and fatigue.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, people need to have been diagnosed with systemic sclerosis. They must be at least 18 years old; there's no upper age limit mentioned.

More detailed eligibility criteria will be discussed by the study team, but generally, participants might need to be in a certain stage of their condition, have particular test results, or not be taking certain other medications that could interfere with the study. It's important to have a chat with your doctor or the study team to see if you fit all the requirements.

If you're interested, the research team will ask you some questions and do some tests to make sure the study is a safe and suitable option for you.

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?
Do you have a diagnosis of systemic sclerosis?
Are you able to attend regular appointments for one year?
Are you willing to potentially receive either the study drug or a placebo?
Are you comfortable with taking an 'add-on' medication to your current treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to either receive hydroxychloroquine tablets or a placebo (a dummy pill that looks the same) for 52 weeks. Neither you nor your study doctor would know which one you are receiving. You would take this medication as an 'add-on' to any other treatments you're already on for systemic sclerosis.

Throughout the 52 weeks, you would have several visits to the clinic. At these visits, doctors would assess your symptoms, pain levels, morning stiffness, and fatigue. They would also check for changes in your skin and blood vessels. These checks happen at specific times, for example, at 26 weeks and 52 weeks, to see how your condition is changing over time. The total duration of active treatment and follow-up in the study is 52 weeks.

Potential risks and benefits

Taking part in this study might offer a potential benefit if you receive the active drug, hydroxychloroquine, and it helps to improve your symptoms more than your current treatment. However, there's also a chance you might receive the placebo and not experience any direct benefit from the study medication. Like all medications, hydroxychloroquine can have side effects, which the study team will explain in detail. You're free to withdraw from the study at any time, for any reason, without it affecting your 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
Italy

Common questions

What is systemic sclerosis?

It's a rare condition where the immune system causes hardening of the skin and other body parts, and affects blood vessels.

What is hydroxychloroquine?

It's a medication, sometimes called Plaquenil, used to treat certain immune system conditions.

What does 'double-blind' mean?

It means neither you nor your doctor will know if you're getting the study drug or the dummy pill.

How long will the study last for me?

If you join, your participation, including treatment and follow-up, will last for 52 weeks (about a year).

Will I still take my regular medication?

Yes, hydroxychloroquine or the placebo would be an 'add-on' to your existing treatments.