In short
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
- Austria
- Belgium
- Study of Amlitelimab and BI 1015550 for Patients with Interstitial Lung Disease Due to Scleroderma
- Study on the Long-Term Safety of Belimumab for Adults with Systemic Sclerosis-Related Lung Disease
- Study on Vixarelimab for Patients with Idiopathic Pulmonary Fibrosis and Systemic Sclerosis-Associated Interstitial Lung Disease
- Denmark
- Espagne
- Finland
- France
- Study of Amlitelimab and BI 1015550 for Patients with Interstitial Lung Disease Due to Scleroderma
- Study of rituximab and mycophenolate mofetil combination therapy compared to placebo for patients with interstitial lung disease related to systemic sclerosis
- Study on the Long-Term Safety of Belimumab for Adults with Systemic Sclerosis-Related Lung Disease
- Study on Vixarelimab for Patients with Idiopathic Pulmonary Fibrosis and Systemic Sclerosis-Associated Interstitial Lung Disease
- Germany
- Study of Amlitelimab and BI 1015550 for Patients with Interstitial Lung Disease Due to Scleroderma
- Study on the Long-Term Safety of Belimumab for Adults with Systemic Sclerosis-Related Lung Disease
- Study on Vixarelimab for Patients with Idiopathic Pulmonary Fibrosis and Systemic Sclerosis-Associated Interstitial Lung Disease
- Greece
- Hungary
- Italy
- Study of Amlitelimab and BI 1015550 for Patients with Interstitial Lung Disease Due to Scleroderma
- Study on the Long-Term Safety of Belimumab for Adults with Systemic Sclerosis-Related Lung Disease
- Study on Vixarelimab for Patients with Idiopathic Pulmonary Fibrosis and Systemic Sclerosis-Associated Interstitial Lung Disease
- Netherlands
- Norway
- Poland
- Portugal
- Spain
- Study of Amlitelimab and BI 1015550 for Patients with Interstitial Lung Disease Due to Scleroderma
- Study on the Long-Term Safety of Belimumab for Adults with Systemic Sclerosis-Related Lung Disease
- Study on Vixarelimab for Patients with Idiopathic Pulmonary Fibrosis and Systemic Sclerosis-Associated Interstitial Lung Disease
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 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.
