RecruitingRare disease

Study on Hydroxychloroquine and Prednisone for Patients with Non-Severe Extra-Pulmonary Sarcoidosis

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What is this trial about?

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

This clinical trial is focused on studying a condition called extra-pulmonary sarcoidosis, which affects parts of the body other than the lungs. The study is investigating the use of a medication called hydroxychloroquine as a way to reduce the need for another medication, prednisone, which is a type of steroid. Steroids are often used to treat inflammation in the body, but they can have side effects, so finding ways to use less of them can be beneficial.

The purpose of the study is to see if adding hydroxychloroquine to the treatment plan can help patients with non-severe extra-pulmonary sarcoidosis who need systemic treatment, meaning treatment that affects the whole body. Participants in the study will be randomly assigned to receive either hydroxychloroquine or a placebo, in addition to their regular treatment. The study will last for a period of up to 24 months, with regular check-ups to monitor the effects of the treatment and any side effects.

Throughout the study, doctors will assess how well the treatment is working by looking at the improvement in symptoms and the ability to reduce the use of prednisone. They will also monitor for any side effects related to the medications. The goal is to determine if hydroxychloroquine can effectively help manage the condition while minimizing the need for steroids, ultimately improving the quality of life for patients with extra-pulmonary sarcoidosis.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be informed about the study's purpose and procedures. You will be required to provide written consent, confirming your understanding and agreement to participate.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your current health status. This may include a physical examination, blood tests, and other necessary evaluations to ensure eligibility for the trial.
Step 3
Medication administration
You will be randomly assigned to receive either hydroxychloroquine sulfate or a placebo. The medication is taken orally in the form of a film-coated tablet. The dosage and frequency will be determined by the study protocol and communicated to you by the study team.
Step 4
Regular follow-up visits
Regular follow-up visits will be scheduled at months 1, 3, 6, 12, 18, and 24. During these visits, your health will be monitored, and any side effects or changes in your condition will be assessed. This includes eye evaluations and heart monitoring.
Step 5
Primary endpoint assessment
At month 12, the primary endpoint will be assessed. This involves evaluating whether you are in remission and off prednisone without relapse.
Step 6
Secondary endpoint assessments
Throughout the trial, secondary endpoints will be assessed, including organ-specific responses, global clinical responses, and quality of life evaluations using the SF36 questionnaire.
Step 7
Completion of the trial
The trial is expected to conclude by September 2028. Upon completion, you will receive information about the study's findings and any further steps if necessary.

Who can join the trial?

5 criteria

Must be at least 18 years old.
Have a condition called non-severe sarcoidosis that affects areas outside the lungs, such as the ears, nose, throat, eyes, skin, bones, joints, or peripheral nerves, and requires treatment that affects the whole body.
Have a confirmed diagnosis of sarcoidosis based on specific medical criteria.
Be able to provide informed and written consent to participate in the study.
Be affiliated with the National French social security system.

Who cannot join the trial?

8 criteria

Patients with other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had an allergic reaction to hydroxychloroquine or similar medications in the past.
Patients who are currently participating in another clinical trial.
Patients who have a history of eye problems related to retinopathy, which is damage to the retina of the eye.
Patients with severe liver or kidney disease.
Patients who have a history of heart rhythm problems.
Patients who are unable to follow the study procedures or attend the required visits.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Paris
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Paris, France
CHU Croix Rousse-Lyon
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Lyon, France
Centre Hospitalier Et Universitaire De Limoges
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Limoges, France

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Investigated drugs

Hydroxychloroquine is a medication that is being tested in this clinical trial to see if it can help reduce the need for steroids in patients with a condition called extra-pulmonary sarcoidosis. This condition affects parts of the body other than the lungs and often requires treatment with steroids, which can have side effects. Hydroxychloroquine is already used to treat other conditions like malaria and certain autoimmune diseases. In this trial, researchers want to find out if adding hydroxychloroquine to the treatment plan can help patients use fewer steroids while still managing their symptoms effectively.

What is already known about the treatment

Hydroxychloroquine – Hydroxychloroquine is taken orally in the form of tablets. It is currently being studied in clinical trials as a potential treatment for extra-pulmonary sarcoidosis, a condition where inflammatory cells collect in parts of the body other than the lungs. The main goal of using hydroxychloroquine in this context is to reduce the need for steroids, which are commonly used to manage this condition. At the molecular level, hydroxychloroquine works by interfering with the communication of cells involved in the immune response, helping to reduce inflammation. It is classified as an antimalarial and immunomodulatory drug.

Investigated diseases

Extrapulmonary Sarcoidosis – Extrapulmonary sarcoidosis is a condition where clusters of inflammatory cells, known as granulomas, form in organs other than the lungs. These granulomas can affect various parts of the body, including the skin, eyes, liver, and lymph nodes. The disease often begins with mild symptoms, such as fatigue and weight loss, and can progress to more specific symptoms depending on the organs involved. For instance, skin involvement may lead to rashes or lesions, while eye involvement can cause vision problems. Over time, the granulomas may cause organ dysfunction if they persist or grow. The progression of the disease varies widely among individuals, with some experiencing only mild symptoms and others facing more significant organ involvement.