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Ongoing Clinical Trials for Sarcoidosis

Sarcoidosis is a condition where small clusters of inflammatory cells form in various parts of the body, most commonly the lungs. Currently, there are 6 ongoing clinical trials testing new treatments to help manage this condition. These studies are exploring different medications that aim to reduce inflammation, decrease the need for steroids, and improve patients’ quality of life. The trials are taking place across multiple European countries, offering opportunities for patients to access new treatment options.

Clinical trial locations

Study of XTMAB-16 and Prednisolone Sodium Phosphate for Patients with Pulmonary Sarcoidosis

This trial is testing a new medication called XTMAB-16, given through an intravenous infusion, for people with pulmonary sarcoidosis. The study is divided into two parts: the first part tests different doses to find the safest and most effective amount, while the second part focuses on whether the treatment can reduce the need for corticosteroids like prednisolone, which are commonly used to control inflammation.

Who can participate: Adults aged 18 to 80 years who have had pulmonary sarcoidosis for at least 6 months. Participants must weigh between 45 kg and 160 kg and be taking 7.5 to 25 mg per day of oral prednisone or equivalent medication. They should also be on stable doses of other medications such as methotrexate, azathioprine, or hydroxychloroquine for at least 3 months. Participants must have a breathlessness score of 1 or more on the Modified Medical Research Conference Dyspnea Scale and test negative for COVID-19.

Who cannot participate: People with conditions other than pulmonary sarcoidosis, those outside the specified age range, and vulnerable populations. Participants must be male or female and able to provide written consent.

Focus of the trial: The study aims to understand how safe and effective XTMAB-16 is in reducing corticosteroid use. Participants will be monitored for side effects and changes in lung function and quality of life. Some participants may receive a placebo to help researchers compare results.

Investigational drug: XTMAB-16 is a monoclonal antibody that targets specific proteins involved in inflammation, aiming to reduce symptoms and improve quality of life for patients with pulmonary sarcoidosis.

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

This trial is investigating whether adding hydroxychloroquine to treatment can help reduce the need for prednisone, a type of steroid, in people with extra-pulmonary sarcoidosis. This condition affects parts of the body other than the lungs, such as the skin, eyes, and lymph nodes.

Who can participate: Adults aged 18 or older who have non-severe extra-pulmonary sarcoidosis requiring systemic treatment. The diagnosis must be confirmed by specific medical criteria. Participants must be affiliated with the National French social security system and able to provide written consent.

Who cannot participate: People with other serious health conditions, those who are pregnant or breastfeeding, anyone with a history of allergic reactions to hydroxychloroquine, individuals currently in another clinical trial, those with eye problems related to retinopathy, people with severe liver or kidney disease, those with heart rhythm problems, and anyone unable to follow study procedures.

Focus of the trial: The study will last up to 24 months and will monitor whether hydroxychloroquine can effectively help manage symptoms while reducing prednisone use. Participants will be randomly assigned to receive either hydroxychloroquine or a placebo and will have regular check-ups to assess treatment effectiveness and side effects.

Investigational drug: Hydroxychloroquine is an antimalarial and immunomodulatory drug that works by interfering with immune cell communication to reduce inflammation.

Study on Azithromycin and Doxycycline for Reducing Inflammation in Sarcoidosis Patients

This trial is exploring whether a combination of two antibiotics, azithromycin and doxycycline, can reduce inflammation in patients with sarcoidosis. The study is particularly interested in cases where a bacterium called C. acnes may be involved in the formation of granulomas.

Who can participate: Patients with sarcoidosis confirmed by biopsy who show inflammatory activity on an FDG-PET scan. Specifically, participants must have an SUVmax above 3 in the lungs or above 5 in the mediastinum or hili. They should not currently need treatment for the condition. Both males and females aged 18 and older can participate.

Who cannot participate: The trial does not include vulnerable populations. Specific exclusion criteria would be determined by the study protocol.

Focus of the trial: The study will monitor participants to see if the antibiotic combination can significantly decrease inflammatory activity. Participants will receive the medications orally in tablet form and will be assessed regularly throughout the trial.

Investigational drugs: Azithromycin is a macrolide antibiotic that stops bacterial growth, while doxycycline is a tetracycline antibiotic that prevents bacteria from multiplying. Both work by inhibiting bacterial protein synthesis.

Study on Long-term Safety of XTMAB-16 for Patients with Pulmonary Sarcoidosis with or without Extra-pulmonary Involvement

This trial is focused on evaluating the long-term safety and effectiveness of XTMAB-16 for managing pulmonary sarcoidosis, whether or not it involves other parts of the body. The medication is given through an intravenous infusion.

Who can participate: Patients with pulmonary sarcoidosis who have completed a previous study called XTMAB-16-201, which involved 12 or 24 weeks of treatment. They must have been on a stable dose of steroids for at least 2 weeks before starting this study. Both men and women can participate, including those considered part of a vulnerable population.

Who cannot participate: People without a diagnosis of pulmonary sarcoidosis, those outside the specified age range, individuals unable to follow study procedures, those with other medical conditions that could interfere with the study, pregnant or breastfeeding women, people currently in another clinical trial, those with a history of allergic reactions to the study medication, individuals with a history of substance abuse, and those with certain mental health conditions.

Focus of the trial: The study will monitor participants over an extended period to assess how well they tolerate the medication and how it affects their condition. Researchers will track side effects, changes in corticosteroid use, lung function, quality of life, and various biological markers that indicate inflammation.

Investigational drug: XTMAB-16 is a monoclonal antibody that targets specific proteins in the immune system to reduce inflammation and prevent granuloma formation.

Study on Stopping Infliximab, Methotrexate, and Azathioprine in Patients with Sarcoidosis in Remission

This trial is studying whether patients who have achieved remission after treatment with infliximab can safely stop taking the medication. Infliximab is a TNF-alpha antagonist that helps reduce inflammation. The study will compare strategies for maintaining remission in patients.

Who can participate: Adults aged 18 or older affiliated with the National French social security system who have a clinical presentation consistent with sarcoidosis. Participants must have non-caseating granulomas in at least one organ, with other causes ruled out. They must have been on infliximab treatment for at least 6 months and taking a steroid dosage of 10 mg per day or less for at least 6 months. Participants should have no disease activity for at least 6 months, as indicated by an ePOST score of 0, and have normal ACE and serum calcium levels.

Who cannot participate: Patients with immune system disorders cannot participate.

Focus of the trial: The study will last up to 12 months and will monitor participants to see how many experience a major relapse when infliximab is stopped. Some participants will continue their current treatment while others will stop taking the medication. The study will also involve methotrexate and azathioprine, which are taken orally.

Investigational drug: Infliximab is administered intravenously and works by blocking TNF-alpha, a protein that causes inflammation. It helps maintain remission in patients with sarcoidosis.

Study on the Effects of XTMAB-16 and Prednisolone in Patients with Pulmonary Sarcoidosis with or without Other Body Involvement

This trial is testing XTMAB-16, given through an intravenous infusion, to evaluate its safety and effectiveness in reducing the need for oral corticosteroids like prednisolone in patients with pulmonary sarcoidosis.

Who can participate: Adults aged 18 to 80 years who have been diagnosed with pulmonary sarcoidosis for at least 6 months, following specific guidelines. Participants must weigh between 45 kg and 160 kg and have a breathlessness score of 1 or higher. They must be taking 7.5 to 25 mg per day of oral prednisone or equivalent medication and have been on stable doses of medications like methotrexate or hydroxychloroquine for at least 3 months. Participants must test negative for COVID-19 and be able to provide written consent.

Who cannot participate: People without pulmonary sarcoidosis, those outside the specified age range, vulnerable populations, individuals unable to follow study procedures, those with other interfering medical conditions, people currently in another clinical trial, those with a history of allergic reactions to similar medications, and pregnant or breastfeeding women.

Focus of the trial: The study is divided into two parts: determining safe dosage levels and assessing effectiveness in reducing corticosteroid use. Participants will be monitored for side effects and changes in their condition, with some receiving a placebo for comparison. The study aims to find out if XTMAB-16 can reduce reliance on corticosteroids and improve quality of life.

Investigational drug: XTMAB-16 is an immunomodulatory agent that targets specific immune system pathways to reduce inflammation. It is administered through injections and is designed to help patients with pulmonary sarcoidosis.

Summary

The six ongoing clinical trials for sarcoidosis represent diverse approaches to managing this complex inflammatory condition. A notable concentration of trials is taking place across multiple European countries, with Denmark, Poland, Italy, Czechia, and Spain hosting the most studies. France and the Netherlands also contribute trials focused on specific aspects of the condition.

A significant focus of these trials is on XTMAB-16, a monoclonal antibody being tested in four studies across various locations. These trials examine both short-term and long-term safety, as well as the potential to reduce corticosteroid dependence in patients with pulmonary sarcoidosis. The repeated testing of this medication suggests it is a promising candidate for new treatment approaches.

Other trials are exploring alternative strategies: hydroxychloroquine for extra-pulmonary manifestations, antibiotic combinations for inflammation reduction, and strategies for safely discontinuing long-term treatments in patients who have achieved remission. These diverse approaches reflect the complex nature of sarcoidosis and the need for multiple treatment options tailored to different presentations of the condition.

Overall, these trials aim to improve patient outcomes by reducing reliance on steroids, which can have significant side effects, and by finding more targeted treatments that address the underlying inflammatory processes in sarcoidosis.

Ongoing Clinical Trials on Sarcoidosis

  • Study of XTMAB-16 and Prednisolone Sodium Phosphate for Patients with Pulmonary Sarcoidosis

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark Italy Poland Spain

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

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Long-term Safety of XTMAB-16 for Patients with Pulmonary Sarcoidosis with or without Extra-pulmonary Involvement

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark Italy Poland Spain

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