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Systemic sclerosis pulmonary – Trials in Disease

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Ongoing Clinical Trials for Systemic Sclerosis Pulmonary

Four clinical trials are currently investigating new treatments for lung disease associated with systemic sclerosis. These studies are testing various medications including amlitelimab, BI 1015550, rituximab, mycophenolate mofetil, belimumab, and vixarelimab in multiple European countries. The trials aim to evaluate how these treatments affect lung function and overall health in patients with this condition.

Clinical trial locations

Study of Amlitelimab and BI 1015550 for Patients with Interstitial Lung Disease Due to Scleroderma

This trial focuses on interstitial lung disease that develops in people with scleroderma, a condition that causes hardening of the skin and can affect internal organs including the lungs. The study is testing two investigational medications: amlitelimab, given as an injection under the skin, and BI 1015550, taken as a tablet by mouth. Some participants will receive these active medications while others will receive inactive placebos for comparison.

Who can participate: The study is looking for adults aged 18 or older who have been diagnosed with systemic sclerosis according to established medical criteria. Participants must have interstitial lung disease visible on lung scans performed within three months of joining the study. The first symptom of their condition (not counting Raynaud’s phenomenon) must have appeared within the past five years. Lung function tests must show that forced vital capacity is at least 45% of normal and the ability of lungs to transfer carbon monoxide is at least 30% of normal. For those with the diffuse form affecting the skin, a skin thickness score between 10 and 35 is required.

Who cannot participate: People with other types of lung diseases not related to their scleroderma are excluded from the study. Those who have had a recent lung infection or other serious illness that could affect results cannot join. The trial also excludes people currently participating in another clinical trial, those with a history of severe allergic reactions to medications, and women who are pregnant or breastfeeding. Individuals with a history of drug or alcohol abuse or any medical condition that doctors believe would make participation unsafe are also excluded.

Study focus: The main goal is to measure changes in lung function over 52 weeks of treatment. Researchers will particularly focus on forced vital capacity, which measures the amount of air a person can exhale after taking a deep breath. Additional assessments will look at lung imaging results, breathing difficulty scores, and skin thickness measurements. The study aims to determine whether these investigational treatments can slow down or improve the decline in lung function that occurs with this condition.

Study of rituximab and mycophenolate mofetil combination therapy compared to placebo for patients with interstitial lung disease related to systemic sclerosis

This French trial is testing a combination treatment approach using two medications together: rituximab and mycophenolate mofetil. Rituximab is given through intravenous infusion, meaning it is delivered directly into a vein, while mycophenolate mofetil is taken by mouth. The study will compare this combination against a placebo plus mycophenolate mofetil to see if adding rituximab provides additional benefits.

Who can participate: Adults aged 18 and older with a confirmed diagnosis of systemic scleroderma who can tolerate taking mycophenolate mofetil up to 1500 mg twice daily may join. Participants must have either severe lung disease affecting 20% or more of their lungs on CT scan or breathing capacity at or below 70% of normal. Alternatively, those with high-risk factors such as being over 60 years old, male gender, early-stage skin disease, African or Caribbean ethnicity, specific antibodies in blood tests, or signs of inflammation may qualify. All participants must have health insurance coverage and be able to provide written consent and attend scheduled appointments. Women of childbearing potential must agree to use appropriate contraception.

Who cannot participate: The study excludes people with active or chronic infections including tuberculosis or severe infections requiring hospitalization. Those with a history of severe allergic reactions to rituximab or similar medications cannot participate. Active cancer or cancer treatment within the past five years, severe heart conditions, uncontrolled high blood pressure, and severe kidney disease requiring dialysis are also exclusionary. Pregnant or breastfeeding women, those with hepatitis B, C, or HIV infection, and people with unstable lung disease requiring oxygen therapy are not eligible. The trial also excludes individuals with severe mental illness that could interfere with participation, those unable to follow study procedures, and people with recent drug or alcohol abuse.

Study focus: The primary aim is to measure changes in lung function, specifically forced vital capacity, at multiple time points throughout the 48-week treatment period. Researchers will conduct assessments at 12, 24, and 48 weeks, including lung function tests, skin thickness measurements using the Rodnan skin score, quality of life questionnaires, walking tests to assess exercise capacity, and physical activity monitoring using an accelerometer device. Blood tests will measure immune system markers. The study seeks to understand whether combining rituximab with mycophenolate mofetil offers better outcomes than mycophenolate mofetil alone.

Study on the Long-Term Safety of Belimumab for Adults with Systemic Sclerosis-Related Lung Disease

This is a long-term extension study that follows participants who have completed a previous trial. It focuses on monitoring the safety and effectiveness of belimumab over an extended period, with the study planned to continue until December 2029. Belimumab is given as an injection under the skin using a pre-filled pen device at a dose of 200 mg.

Who can participate: This trial is specifically designed for people who completed a previous belimumab study up to the 52-week visit without experiencing treatment failure. Treatment failure is defined as needing to start new medications for the disease or stopping the study medication for any reason. Participants must have an area of skin suitable for injection, either on the belly or the front of the thigh. They must be capable and willing to give themselves the injection or have a caregiver or healthcare professional who can administer it throughout the study. Women must not be pregnant or breastfeeding and must either be unable to have children or use highly effective birth control during the study and for at least four months after the last dose. A negative pregnancy test is required before starting.

Who cannot participate: Individuals with bronchial diseases, which are conditions affecting the airways in the lungs, cannot participate in this extension study.

Study focus: The primary objective is to monitor long-term safety and tolerability of belimumab in people with this condition. Participants will be regularly assessed for any adverse effects or unexpected reactions to the medication. Lung function measurements, specifically forced vital capacity, will be conducted at weeks 12, 26, and 52, and then every 52 weeks thereafter. The study provides valuable information about whether belimumab remains safe and effective over several years of continuous use.

Study on Vixarelimab for Patients with Idiopathic Pulmonary Fibrosis and Systemic Sclerosis-Associated Interstitial Lung Disease

This trial studies vixarelimab, a medication given as an injection under the skin. The study includes people with two different lung conditions: idiopathic pulmonary fibrosis and systemic sclerosis-associated interstitial lung disease. Participants will be randomly assigned to receive either vixarelimab or a placebo, and the study will last up to 104 weeks.

Who can participate: Eligible participants must have a forced vital capacity of at least 45% of the predicted normal value and a FEV1/FVC ratio greater than 0.70. The diffusion capacity for carbon monoxide must be between 30% and 90% of predicted. Participants must be able to walk at least 150 meters in a 6-minute walk test while using a maximum of 6 liters per minute of supplemental oxygen at sea level, or up to 8 liters per minute at higher altitudes, and maintain oxygen saturation above 83% during the test. For those in the systemic sclerosis group, a diagnosis according to specific medical criteria is required. Both adults and older adults of any gender may participate.

Who cannot participate: People with any lung disease other than the two conditions being studied cannot participate. Those outside the specified age range, pregnant or breastfeeding women, and people who recently participated in another clinical trial may be excluded. A history of severe allergic reactions to medications, uncontrolled medical conditions that could interfere with the study, and inability to comply with study procedures and visits are also reasons for exclusion.

Study focus: The study aims to evaluate how well vixarelimab works in improving lung function compared to placebo. Researchers will conduct regular follow-up visits throughout the treatment period to monitor health through various assessments including lung function tests, walk tests, and questionnaires about quality of life and symptoms. The medication works by targeting specific proteins involved in inflammation and tissue damage, helping to reduce these harmful effects. At the end of the treatment period, comprehensive evaluations will assess any changes since the start of the study.

Summary

These four clinical trials represent important research efforts to find better treatments for lung disease associated with systemic sclerosis. The studies are spread across multiple European countries, with the highest concentration of trials in Belgium, France, Germany, Italy, and Spain, reflecting strong research interest in these regions.

All four trials focus on measuring lung function, particularly forced vital capacity, as a key indicator of treatment success. The studies test different approaches: two trials examine single medications (belimumab and vixarelimab), one tests a combination of two drugs already under investigation (amlitelimab and BI 1015550), and one explores combining rituximab with mycophenolate mofetil. Treatment durations range from 48 to 104 weeks, with one long-term safety study extending until 2029.

The medications being studied work through different mechanisms, mostly involving regulation of the immune system and reduction of inflammation. Some are delivered by injection under the skin, while others are taken orally, offering different options for patients. Entry requirements across the trials are generally similar, requiring documented diagnosis, specific lung function measurements, and ability to participate in regular assessments. Common exclusion criteria include other lung diseases, active infections, pregnancy, and conditions that could interfere with safe participation.

Ongoing Clinical Trials on Systemic sclerosis pulmonary

  • Study on Vixarelimab for Patients with Idiopathic Pulmonary Fibrosis and Systemic Sclerosis-Associated Interstitial Lung Disease

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Greece Hungary Italy +2

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