The purpose of the study is to demonstrate the efficacy of maintaining RTX as a maintenance strategy in individuals with stabilized SSc‑ILD following RTX induction treatment. Participants receive the assigned infusion every few months for a total period of about 18 months, with clinic visits scheduled at regular intervals to monitor health.

During the study, lung function is checked using measurements such as FVC, which assesses the amount of air a person can forcefully exhale, and DLCO, which evaluates how well oxygen passes from the lungs into the blood. Imaging of the chest is performed with a HRCT scan, and physical capacity is measured with a 6‑min walk test that records the distance walked in six minutes. Additional assessments include questionnaires about quality of life and safety checks.

People in the study are assigned by chance to receive either lebrikizumab or placebo. The study is double-blind, which means that the people taking part and the study team do not know which treatment is being given. Treatment is given regularly over a period of about 24 weeks, and the skin condition is checked during the study. Side effects and general safety are also monitored.

The purpose of this study is to assess the safety of cizutamig in patients with these severe inflammatory conditions and to examine how well the treatment works in controlling disease activity. During the study, patients will receive the medication and will be closely monitored for any side effects, particularly Cytokine Release Syndrome and other treatment-related reactions. The study will track various measures of disease activity specific to each condition, such as skin thickness scores for systemic sclerosis, muscle strength measurements for inflammatory myopathy, disease activity scores for rheumatoid arthritis, and symptom scores for Sjögren’s disease. For patients who have lung involvement, lung function tests will also be performed.

The study will last approximately 52 weeks, with regular assessments at different time points to evaluate both the safety and effectiveness of the treatment. Patients will have measurements taken at weeks 16, 24, and 52 to see how their disease responds to cizutamig. The study will also look at whether patients can reduce or stop other medications they may be taking, how often their disease flares up, and how their overall quality of life and daily functioning change during the treatment period.

The purpose of this study is to evaluate the safety of this cell therapy in patients whose autoimmune disease has continued to progress despite receiving treatments that remove B cells from the body. B cells are a type of immune cell that produces antibodies, and in autoimmune diseases, these cells can contribute to the harmful immune response. The study will specifically look at serious side effects including problems with the immune system’s response to the treatment, such as cytokine release syndrome and nervous system complications, as well as damage to organs that does not improve quickly.

During the study, patients will receive the modified T cell treatment and will be closely monitored for any side effects and how their body responds to the therapy. The study will track whether patients experience any severe reactions and how long it takes for these reactions to resolve with appropriate medical care. Patients participating in this study will have already tried multiple standard treatments for their autoimmune disease without success, including at least one treatment specifically designed to eliminate B cells from the body.

Participants will receive QEL-005 through an intravenous infusion, which is a method of delivering the medicine directly into a vein. The study is conducted in stages to monitor how the body reacts to the treatment. During this process, health professionals will monitor for any side effects or changes in vital signs and electrocardiogram, a test that records the electrical activity of the heart, to ensure the safety of the procedure.

The purpose of the study is to evaluate the long-term safety of KYV-101. Participants will be monitored over an extended period to observe how the body reacts to the medication over time. This involves checking for the development of new health issues, such as malignancy, which refers to cancerous growths, or any changes in existing neurologic conditions, which are related to the brain and nervous system. The study also tracks changes in rheumatologic issues, which involve the joints and connective tissues, or hematologic disorders, which are conditions affecting the blood.

The purpose of the study is to evaluate the use of 68Ga-FAPI-46 to detect scar tissue inside the body. This substance is a radiopharmaceutical, which is a specialized drug used for medical imaging. Participants will undergo a PET/CT scan, a method that combines two types of imaging to create detailed pictures of the body’s internal structures. During the process, the substance is administered through an intravenous injection, meaning it is delivered directly into a vein.

Throughout the study, the imaging results will be compared with biological samples to see how well the scan identifies certain markers of scarring. Researchers will also look at how the substance moves through the body and how it can be used to better understand the progression of these diseases. This information may help in finding new ways to diagnose or treat scarring in the future.

Participants in this study will receive their assigned treatment for 12 months. During this time, they will undergo various examinations to monitor how the disease is affecting their body. These examinations will include measurements of skin thickness, imaging tests such as magnetic resonance imaging to look at the heart and computed tomography to examine the lungs, tests to check kidney function, and blood tests to measure inflammation markers. Participants will also have a procedure called capillaroscopy, which looks at tiny blood vessels in the fingernails, and will complete questionnaires about their quality of life and emotional well-being.

Throughout the study, doctors will carefully monitor participants for any side effects or unwanted reactions to the treatments. The study will measure changes in disease severity using a scoring system that assesses skin thickness in different areas of the body. Additional measurements will evaluate how the disease affects various organs including the heart, lungs, and kidneys, as well as the overall impact on daily life and mental health. The entire treatment period will last 12 months, during which participants will attend regular visits for examinations and assessments.

The purpose of the study is to find out if tibulizumab can reduce skin thickness in people with systemic sclerosis and to check how safe the medicine is when used over time. The study is divided into two periods. In the first period, which lasts 24 weeks, participants will be randomly assigned to receive either tibulizumab or placebo, and neither the participants nor the doctors will know which treatment is being given. In the second period, all participants will receive tibulizumab for an additional 28 weeks, and everyone will know they are receiving the actual medicine.

During the study, doctors will measure skin thickness using a scoring system, check lung function through breathing tests that measure how much air the lungs can hold, and use special scans to look at the lungs in detail. Participants will also complete questionnaires about their ability to perform daily activities. Throughout both periods, the study team will monitor for any unwanted effects of the treatment by checking vital signs, heart activity, and blood test results. The total treatment time for each participant can be up to 48 weeks.

The purpose of this study is to evaluate whether this modified cell therapy can improve skin thickening and fibrosis in patients with systemic sclerosis who have not responded adequately to standard treatments. The study will measure changes in skin thickness using a scoring system and will also look at other aspects of the disease, including lung function, heart function, and overall quality of life.

During the study, patients will first undergo a procedure called leucapheresis to collect their T-cells from the blood. These cells will then be modified in the laboratory and given back to the patient as a single treatment. After receiving the modified cells, patients will be monitored for six months to assess how well the treatment works and to check for any side effects. The study will also track the presence and activity of these modified cells in the body over time, as well as changes in different types of immune cells.

The study aims to examine how specific immune cells called B cells respond to the tetanus vaccine in people with autoimmune diseases. Participants will receive a single booster shot of the tetanus vaccine as a suspension for injection into the muscle. The amount given will be 0.5 milliliters, which is a standard vaccine dose.

During the study, researchers will collect blood samples at different times to observe how the immune system responds to the vaccine. They will look at special immune cells and proteins in the blood before and after vaccination. This will help them understand the differences between how the immune system works in people with autoimmune diseases compared to people without these conditions.

Before receiving the main treatment, patients will undergo preparation with two medications: cyclophosphamide and fludarabine, which help reduce certain immune cells in the body. The purpose of this study is to determine if this combination treatment is safe and if it can help improve symptoms in patients with these hard-to-treat rheumatic conditions.

The treatment involves receiving the medications through intravenous infusion (delivery directly into a vein). Patients will receive multiple doses of the study medications over several weeks and will be monitored regularly to check how well the treatment works and to watch for any side effects. The study will track various measurements of disease activity and symptoms specific to each condition to determine if the treatment is effective.

The treatment involves injections of stem cells derived from fatty tissue, combined with sodium chloride solution and albumin. These injections are intended to help reduce mouth fibrosis (tissue hardening) and improve mouth function in people with systemic scleroderma. The study will measure how well the treatment works by assessing changes in mouth movement and daily activities like eating and speaking.

Participants will receive the treatment and be monitored for 24 weeks. During this time, doctors will track various aspects of mouth function, including the ability to open the mouth, overall oral health, and any changes in facial tissue. They will also monitor the safety of the treatment by checking for any side effects or reactions at the injection sites.

The purpose of this research is to determine if Blinatumomab is safe and well-tolerated by patients with these conditions. The medication is given through an intravenous infusion, which means it is delivered directly into a vein. The treatment involves receiving the medicine over a period of 10 days, with a specific daily amount that has been carefully determined for safety.

During the study, patients will be monitored for 52 weeks (one year) to check how their body responds to the treatment. The research team will track any side effects that may occur and measure how well the treatment works by checking blood tests for specific antibodies and evaluating disease symptoms. This is an open-label study, which means all participants will receive the active medication.

Participants in the study will receive either Rituximab or a placebo, which is a substance with no active medication, over a period of one year. The study will monitor the participants to see if there are any differences in the progression of the disease between those receiving Rituximab and those receiving the placebo. The main focus will be on changes in skin and lung involvement, which are common issues in Systemic Sclerosis.

Throughout the study, additional outcomes will be assessed, such as changes in other organs, quality of life, and patient satisfaction. The study will also look at the safety of the treatment and its cost-effectiveness. The trial is expected to continue for a total of 18 months, with follow-up assessments to gather comprehensive data on the effects of the treatment.

The purpose of the study is to assess the safety of CNTY-101 in people with active autoimmune diseases driven by B-cells, which are a type of immune cell. Participants in the study will receive the treatment through an intravenous infusion, which means it will be delivered directly into the bloodstream. The study will monitor participants over time to see how they respond to the treatment and to check for any side effects.

Throughout the study, participants will be closely observed to ensure their safety and to gather information on how the treatment affects their condition. The study aims to provide valuable insights into the potential benefits and risks of using CNTY-101 for treating these autoimmune diseases. This research could lead to new ways of managing these conditions in the future.

The purpose of the study is to assess the effectiveness and safety of efgartigimod PH20 SC. Participants in the study will receive either the treatment or a placebo. The study will monitor changes in skin condition over a period of time, specifically looking at improvements in skin thickness and overall health. Participants will be observed for any side effects or changes in their health during the study.

The study will last for several months, with regular check-ups to track progress. Participants will have their skin condition assessed at different points in time to see how well the treatment is working. The study aims to provide valuable information on whether efgartigimod PH20 SC can be a beneficial treatment for those living with Systemic Sclerosis.

The main purpose of the study is to evaluate the safety of T-Guard in patients with early stages of dcSSc. Participants in the study will receive T-Guard through an intravenous infusion, which means it will be administered directly into a vein. The study will monitor participants for any side effects or adverse events that may occur during and after the treatment. This includes tracking any serious or infectious side effects for up to 365 days after the treatment begins.

Throughout the study, various health assessments will be conducted to observe changes in the condition of the participants. These assessments will include skin evaluations, lung function tests, and quality of life questionnaires. The study aims to gather information on how T-Guard affects the progression of dcSSc and its impact on the participants’ overall health and well-being. Participants will be closely monitored to ensure their safety and to collect valuable data on the effectiveness of the treatment.

The purpose of the study is to see if ianalumab can improve symptoms of diffuse cutaneous systemic sclerosis over a period of 52 weeks. Participants will be randomly assigned to receive either ianalumab or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The study will involve regular visits to the clinic for assessments and monitoring of health, including blood tests and other evaluations to check the response to the treatment and any side effects.

In addition to ianalumab, the study will also involve other medications such as tenofovir alafenamide, emtricitabine, tenofovir disoproxil, and entecavir, which are antiviral drugs. These medications are taken orally, meaning they are swallowed in pill form. The study aims to gather information on how these treatments affect the disease and to ensure they are safe and well-tolerated by participants. The trial is expected to continue until 2030, with the recruitment of participants starting in 2024.

The purpose of the study is to evaluate the safety and effectiveness of these investigational treatments in people with SSc-ILD. Participants will be randomly assigned to receive either the investigational treatment or a placebo. The study will last for a period of 52 weeks, during which participants will receive regular doses of the assigned treatment. Throughout the study, participants will undergo various assessments to monitor their lung function and overall health.

The main goal is to observe any changes in lung function, specifically measuring the forced vital capacity (FVC), which is the amount of air a person can exhale after taking a deep breath. This will help determine if the investigational treatments can improve lung function in people with SSc-ILD. The study will also look at other health indicators to provide a comprehensive understanding of the treatments’ effects. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

The purpose of the study is to determine if Itacitinib can decrease skin fibrosis, which is the thickening and scarring of connective tissue, in patients with diffuse systemic sclerosis. Participants in the study will take either Itacitinib or a placebo for a period of 360 days. The main goal is to observe changes in the skin’s condition using a method called the modified Rodnan skin score, which measures the extent of skin thickening.

Throughout the study, researchers will also monitor the safety of Itacitinib, the activity of systemic sclerosis, and the overall quality of life and disability of the participants. This trial aims to provide valuable information on whether Itacitinib can be an effective treatment option for people living with 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 purpose of the study is to assess the safety of this new treatment in patients with active forms of these autoimmune diseases. Participants in the study will receive the treatment through an infusion, which means it will be administered directly into the bloodstream. The study will monitor participants for any side effects or reactions to the treatment, particularly focusing on any signs of Cytokine Release Syndrome and CAR T cell Associated Neurotoxicity Syndrome within the first few weeks after receiving the treatment.

Throughout the study, participants will be closely observed to ensure their safety and to gather information on how the treatment affects their condition. The study aims to provide valuable insights into the potential of this innovative therapy for managing these challenging autoimmune diseases. The trial is expected to continue until 2026, allowing researchers to collect comprehensive data on the treatment’s safety and effects over time.

The purpose of the study is to evaluate how effective, safe, and tolerable HZN-825 is for patients with Diffuse Cutaneous Systemic Sclerosis. Participants in this study will take the medication twice a day for a period of 52 weeks. This study is an extension of a previous trial, meaning it continues the research from an earlier phase to gather more information about the medication’s effects over a longer period.

Throughout the study, participants will be monitored to see how their condition changes, particularly looking at lung function and physical abilities. The study aims to provide valuable insights into the potential benefits and any side effects of using HZN-825 for treating Diffuse Cutaneous Systemic Sclerosis.

The purpose of this research is to determine if rapcabtagene autoleucel is more effective than rituximab in treating severe dcSSc that has not responded well to previous treatments. Before receiving the main treatment, patients may receive preparation medications including cyclophosphamide, fludarabine phosphate, and tocilizumab. All medications will be given through an intravenous line directly into the bloodstream.

Throughout the study, which lasts for 52 weeks, doctors will monitor changes in lung function, skin thickness, and ability to perform daily activities. They will also track any side effects that may occur during or after treatment. The study will continue to follow participants for several years to understand the long-term effects of the treatment.

The purpose of this study is to evaluate the safety of this cell therapy in patients with severe systemic sclerosis. Participants in the study will receive the cell treatment once or twice over a period of three months. The study will monitor the participants for any side effects and assess how the treatment affects their condition. The trial will also include a comparison with a placebo to better understand the effects of the cell therapy.

Throughout the study, participants will have regular check-ups to monitor their health and the progression of their disease. The study will last for about a year, with follow-up visits to assess the long-term effects of the treatment. The goal is to determine if this new therapy can be a safe and effective option for people with severe systemic sclerosis.

The purpose of the study is to see if belimumab can help reduce the decline in lung function in people with SSc-ILD. Participants will receive either belimumab or a placebo, in addition to their usual treatment, over a period of 52 weeks. The study will monitor changes in lung volume and other health measures to determine the effectiveness and safety of belimumab.

Participants will be asked to self-administer the injections or have a caregiver do it for them. The study aims to provide more information on whether belimumab can be a helpful treatment for people with SSc-ILD, potentially improving their quality of life by slowing down the progression of lung disease.

The purpose of the study is to evaluate how effective and safe sodium thiosulfate is in treating calcinosis cutis in patients with systemic sclerosis. Participants in the study will receive sodium thiosulfate treatment and will be monitored over a period of time to see if there is a reduction in the calcium deposits. The study will use various methods, including imaging techniques, to assess changes in the condition of the skin and the size of the calcium deposits. These imaging techniques may include methods like MRI and other advanced scans to provide detailed pictures of the affected areas.

Throughout the study, participants will have regular check-ups to monitor their progress and any changes in their condition. The study aims to determine whether sodium thiosulfate can help reduce the size of the calcium deposits and improve the symptoms of calcinosis cutis. The results of this study could provide valuable information on a potential treatment option for patients with this challenging condition.

The purpose of the study is to assess how effective and safe HZN-825 is for patients with this condition. Participants in the study will receive either the medication or a placebo, and their progress will be monitored over a period of 52 weeks. The main focus will be on changes in lung function, specifically looking at something called forced vital capacity (FVC), which measures how much air a person can exhale after taking a deep breath.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their condition. The study aims to provide valuable information on whether HZN-825 can be a beneficial treatment option for people living with Diffuse Cutaneous Systemic Sclerosis.

The study compares anifrolumab (MEDI-546) to placebo in adults with Systemic Sclerosis. The medication is given as a subcutaneous injection, which means it is administered under the skin. Participants may continue using their standard treatments during the study, including medications such as hydroxychloroquine, methotrexate, azathioprine, or mycophenolate mofetil.

The main goal of this research is to determine if anifrolumab works better than placebo in improving the signs and symptoms of Systemic Sclerosis. The study will measure changes in skin thickness, breathing function, daily activities, and overall well-being. The treatment period lasts for up to 104 weeks, during which participants will receive regular evaluations to monitor their response to the treatment and any potential side effects.

The purpose of the study is to compare the effectiveness and safety of injecting these stem cells directly into the affected areas of the fingers against a placebo. The trial will last for 16 weeks, during which participants will receive injections and be monitored for improvements in their ulcers. The goal is to see if the ulcers heal completely or partially without coming back and to ensure there are no complications from the treatment.

Participants in the study will receive regular check-ups to monitor their progress and any changes in their condition. The study is designed to provide valuable information on whether this new treatment can offer a better solution for patients suffering from systemic sclerosis with chronic finger ulcers. The findings could potentially lead to improved treatment options for managing this challenging condition.

Participants in the study will be randomly assigned to receive either the BI 685509 tablets or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for at least 48 weeks, during which participants will take the tablets orally. Throughout the study, participants will have regular check-ups to monitor their health and assess any changes in their condition.

The main goal is to see if BI 685509 can slow down the decline in lung function over the course of the study. Additionally, researchers will look at other aspects of systemic sclerosis, such as skin symptoms and overall health, to understand the full impact of the treatment. This study aims to provide valuable information on the safety and effectiveness of BI 685509 for people living with systemic sclerosis.

The purpose of the study is to evaluate the safety and effectiveness of the combination of nintedanib and tocilizumab over a period of 56 weeks. During the study, participants will receive either the combination treatment or the standard treatment. The study will involve regular check-ups and assessments, including imaging tests like computed tomography (CT) and other evaluations to monitor lung function and overall health. Some participants may also receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments.

Throughout the study, researchers will closely monitor the participants’ health and any changes in their condition. The goal is to determine if the combination of nintedanib and tocilizumab can provide better outcomes for patients with systemic sclerosis and interstitial lung disease compared to the standard treatments. This research could lead to improved treatment options for people living with these challenging conditions.

The purpose of the study is to determine if this treatment is safe and potentially effective for patients with Systemic Sclerosis who have complications related to blood flow in their extremities. Participants in the study will receive the treatment through an injection into the muscle. The study will monitor the safety of the treatment over a period of 12 weeks, looking for any side effects or adverse reactions. Additionally, the study will assess changes in pain levels, quality of life, hand function, and the number of digital ulcers.

Throughout the study, various assessments will be conducted to evaluate the impact of the treatment on the severity of the disease, including changes in skin condition and symptoms like Raynaud’s phenomenon, which causes fingers and toes to feel numb and cold. The study will also look at changes in blood vessel structure using a technique called nailfold capillaroscopy, which involves examining the small blood vessels near the surface of the skin. The trial aims to provide valuable information on whether Mesenchymal stem cells can be a beneficial treatment option for people with Systemic Sclerosis.