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Study of Hydroxychloroquine Safety and Effectiveness in Patients with Early Systemic Sclerosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Systemic Sclerosis is a rare disease that affects the immune system, blood vessels, and causes hardening of the skin and internal organs. This condition belongs to a group of autoimmune diseases, where the body's immune system attacks its own tissues. The study aims to test whether adding hydroxychloroquine to standard treatments helps patients with early-stage Systemic Sclerosis.

The study will compare two groups of patients - one receiving hydroxychloroquine tablets and another receiving a placebo. Both groups will continue their standard treatments for Systemic Sclerosis. The medication or placebo will be taken by mouth daily for 52 weeks (one year). The daily dose of hydroxychloroquine will be calculated based on body weight, with a maximum dose of 400 mg per day.

During the study, doctors will monitor various aspects of the disease, including skin changes, blood vessel function, pain levels, morning stiffness, and fatigue. They will also check how well patients can perform daily activities and track any changes in their overall condition. Regular check-ups will occur throughout the year-long study period to ensure patient safety and evaluate how well the treatment is working.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive either hydroxychloroquine tablets or placebo tablets (inactive substance that looks like the real medicine).

    The medication dose is calculated based on your body weight - 6 mg per kilogram of body weight daily, up to a maximum of 400 mg per day.

    The tablets should be taken by mouth according to the provided schedule.

    This treatment will be added to your current systemic sclerosis medications, which must remain stable for at least 4 weeks before starting.

  2. Step 2

    26-week assessment

    Your condition will be evaluated using several measurements:

    Assessment of pain using a visual scale

    Measurement of morning stiffness duration in minutes

    Evaluation of fatigue using the FACIT fatigue Index

    Assessment of Raynaud's condition (blood circulation in fingers and toes)

  3. Step 3

    52-week assessment

    Final evaluation will include all previous measurements plus:

    Assessment of overall disease activity using medical scoring systems

    Examination of small blood vessels in the nail fold area using special microscope (Nailfold Capillaroscopy)

    Evaluation of treatment effectiveness using the Combined Response Index for Systemic Sclerosis

    This marks the end of the main study period

Who can join the trial?

7 criteria

  • Must be diagnosed with Systemic Sclerosis (SSc) according to specific medical criteria
  • Must be able to understand and sign a written informed consent form agreeing to participate in the study
  • Must be 18 years of age or older
  • Must have had the disease for 5 years or less, counting from the first symptom not related to Raynaud's phenomenon (a condition affecting blood circulation to certain parts of the body)
  • Must be on a stable treatment plan for Systemic Sclerosis for at least 4 weeks before the initial screening visit
  • Must either:
    • Have never taken hydroxychloroquine before, or
    • Have stopped taking hydroxychloroquine at least 16 weeks before starting the study

Who cannot join the trial?

18 criteria

  • Age under 18 years or over 65 years
  • Known allergy or sensitivity to hydroxychloroquine or similar medications
  • Pregnancy or breastfeeding
  • Significant heart problems or irregular heartbeat
  • Severe kidney disease (when kidneys don't work properly)
  • Severe liver disease (when liver doesn't work properly)
  • Eye problems affecting the retina (the light-sensitive part of the eye)
  • Current participation in other clinical trials
  • Mental conditions that may affect ability to give informed consent
  • History of serious blood disorders
  • Uncontrolled diabetes mellitus (high blood sugar levels)
  • Active or chronic infections
  • History of seizures or epilepsy
  • Severe muscle weakness conditions
  • Taking medications that could interact with hydroxychloroquine
  • Having received any experimental treatment within 3 months before the study
  • Unable to follow study procedures or attend scheduled visits
  • History of alcohol or drug abuse within the past year
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Investigated drugs

Hydroxychloroquine is a medication commonly used to treat malaria and certain autoimmune conditions. In this trial, it is being studied as a treatment for early systemic sclerosis. The medication works by reducing inflammation in the body and modifying how the immune system functions. It comes in tablet form and is taken orally. Standard systemic sclerosis therapies are also used in this trial, including: Immunosuppressive medications are drugs that lower the body's immune response. They help control the overactive immune system that causes damage in systemic sclerosis. Vasoactive medications are drugs that affect blood vessels. They work by helping to improve blood flow and treating circulation problems that occur in systemic sclerosis.

What is already known about the treatment

Hydroxychloroquine - An oral medication administered in tablet form at a dose of up to 400 mg daily, which has established use in treating various autoimmune conditions. It belongs to the antimalarial drug class but is widely used in rheumatology for its immunomodulatory properties. The medication works by interfering with lysosome function in cells and reducing inflammation, helping to manage symptoms in autoimmune disorders such as systemic sclerosis (SSc). Currently being studied in clinical trials as an add-on therapy for early systemic sclerosis, combined with standard immunosuppressive and vasoactive treatments, with ongoing research to evaluate its efficacy and safety profile in this specific condition.

Investigated diseases

Systemic Sclerosis - A rare autoimmune disease that affects the body's connective tissues. The condition involves abnormal changes in blood vessels, immune system, and fibrous tissues. It causes hardening and tightening of the skin and internal organs due to excessive collagen production. The disease typically begins with circulation problems in fingers and toes, known as Raynaud's phenomenon. As the disease progresses, it can affect multiple body systems, causing changes in the skin, joints, and various internal organs. The condition varies significantly from person to person in terms of which body parts are affected and how quickly changes occur.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516050-22-00Protocol codeHYDROXYSScEstimated enrolment151 patientsSponsorAzienda Ospedaliero-Universitaria Policlinico Umberto I

sourced from the EU Clinical Trials Register and site verification

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