Ongoing Clinical Trials for Immunoglobulin G4 Related Disease
Currently, there are 6 clinical trials investigating new treatments for Immunoglobulin G4 related disease. These studies are testing different medications including imaging agents, immunosuppressive drugs, and biological therapies aimed at preventing disease flare-ups and improving patient outcomes. (Also known as: IgG4-RD, IgG4-related disease)
Clinical trial locations
- Belgium
- Espagne
- France
- Germany
- Hungary
- Italy
- Netherlands
- Study on Filgotinib for Patients with Refractory Behcet’s Disease, Idiopathic Inflammatory Myopathies, and IgG4-Related Disease
- Study on the Safety and Effectiveness of Filgotinib for Patients with Refractory Behcet’s Disease, Idiopathic Inflammatory Myopathies, and IgG4-Related Disease
- Study on the Effectiveness of Inebilizumab for Patients with IgG4-Related Disease
- Study on the Effects of Obexelimab for Patients with IgG4-Related Disease
- Poland
- Spain
- Sweden
Study of 18F-AlF-FAPI-74 PET/CT imaging compared to standard 18F-FDG PET/CT in patients with fever of unknown origin, IgG4-related disease, and axial spondyloarthritis
This Belgian study is evaluating a new imaging method for detecting and assessing inflammatory conditions, including IgG4-related disease. The trial compares a new imaging tracer called 18F-AlF-FAPI-74 with the standard 18F-FDG tracer, both used in combination with PET/CT scanning.
Main inclusion criteria: Participants must be at least 18 years old. For those with IgG4-related disease specifically, they must have high clinical suspicion of the condition by an internal medicine specialist, have had or plan to have a PET/CT scan within 2 weeks, and have moderate to high disease activity if previously diagnosed. Women participants must be either post-menopausal, surgically unable to become pregnant, or using effective birth control with a negative pregnancy test.
Main exclusion criteria: The study excludes patients under 18 years old, pregnant or breastfeeding women, those with known allergies to study medications or contrast agents, and those unable to lie still for approximately 30 minutes during the scan. Patients with severe claustrophobia, those exceeding the scanner weight limit, or those with serious medical conditions that could interfere with participation are also excluded.
Focus and goal: The study aims to determine if the new imaging tracer can work as well as or better than the current standard method in detecting and evaluating inflammatory conditions. It will look at how well each tracer can assess the extent of IgG4-related disease and identify areas of inflammation in affected organs.
Investigational drugs: The study uses two imaging tracers: 18F-AlF-FAPI-74, a novel tracer that targets fibroblasts active during inflammation, and 18F-FDG, the standard tracer that targets cells using high amounts of glucose. These are not treatments but diagnostic tools injected before scanning to help doctors visualize inflammation in the body.
Study on Abatacept for Patients with IgG4-Related Disease
This Italian clinical trial is investigating abatacept, a medication designed to reduce inflammation by targeting specific immune system cells, as a treatment to prevent disease recurrence in patients with IgG4-related disease.
Main inclusion criteria: Participants must be of legal age and able to provide informed consent. They must have active IgG4-related disease that is either untreated or has relapsed with a disease activity index score greater than 2. Participants must also meet the 2019 ACR/EULAR Classification Criteria for the condition.
Main exclusion criteria: Patients with other serious health conditions that could interfere with the study, those currently participating in another clinical trial, patients with recent infections requiring antibiotics, and those with a history of allergic reactions to the study medication are excluded. Pregnant or breastfeeding women, patients with a history of drug or alcohol abuse, and those who have received certain medications that could affect results cannot participate.
Focus and goal: The study will last 48 weeks and aims to determine if abatacept can effectively reduce the risk of disease recurrence. Participants will receive either abatacept or a placebo through subcutaneous injections, with regular assessments to track progress and monitor for symptom changes.
Investigational drug: Abatacept works by interfering with the activity of certain immune cells, specifically B and T cells, which are involved in inflammation. By targeting these cells, the medication aims to decrease the immune response contributing to the disease, potentially leading to fewer symptoms and lower chances of recurrence.
Study on Filgotinib for Patients with Refractory Behcet’s Disease, Idiopathic Inflammatory Myopathies, and IgG4-Related Disease
This Dutch study is examining filgotinib, a JAK-inhibitor medication, for treating several rare inflammatory diseases including IgG4-related disease. The trial focuses on patients whose symptoms have not improved with standard treatments.
Main inclusion criteria: Participants must be 18 years or older with refractory disease, meaning symptoms continue despite 12 weeks of corticoid therapy and lack of response to at least prednisone and one other medication, or inability to tolerate standard treatments. For IgG4-related disease specifically, patients must have active disease diagnosed according to 2019 guidelines, with a responder index greater than 10. Participants must have no evidence of active or latent tuberculosis, confirmed by negative tests and chest X-ray.
Main exclusion criteria: Patients with active infections, serious allergic reactions to similar medications, severe heart or liver problems, uncontrolled high blood pressure, and unstable kidney disease cannot participate. Pregnant or breastfeeding women, those who participated in another trial within 30 days, and patients with cancer history in the last 5 years are also excluded.
Focus and goal: The study will examine how filgotinib affects quality of life, disease activity, and safety over a period of time. Participants will receive either filgotinib or placebo in the form of film-coated tablets taken orally, with regular monitoring through forms and assessments.
Investigational drug: Filgotinib is a JAK-inhibitor that works by blocking certain enzymes in the body involved in the immune response. This can help reduce symptoms such as pain and swelling in conditions where the immune system attacks the body’s own tissues.
Study on the Safety and Effectiveness of Filgotinib for Patients with Refractory Behcet’s Disease, Idiopathic Inflammatory Myopathies, and IgG4-Related Disease
This is another Dutch study on filgotinib, focusing on safety and effectiveness for patients with rare inflammatory diseases including IgG4-related disease who have not responded well to standard treatments.
Main inclusion criteria: Participants must be 18 years or older with refractory disease that continues to show symptoms despite trying corticoid therapy for 12 weeks and not responding to at least prednisone and one other medication. For IgG4-related disease, patients must have active disease diagnosed according to 2019 guidelines, with a responder index score greater than 10. No evidence of active or latent tuberculosis is required, confirmed through blood tests and chest X-ray.
Main exclusion criteria: Patients with active infections, serious allergic reactions to similar medications in the past, severe liver or heart disease, uncontrolled high blood pressure, and severe kidney disease are excluded. Pregnant or breastfeeding women, those who participated in another clinical trial within 30 days, and patients with certain types of active cancer cannot participate.
Focus and goal: The study will last up to 26 weeks, during which participants will take either Jyseleca 100 mg or 200 mg film-coated tablets orally. Some participants may receive a placebo. The trial aims to gather information about the potential benefits and risks of using filgotinib for these rare inflammatory diseases.
Investigational drug: Filgotinib works by blocking specific pathways in the immune system that contribute to inflammation, potentially helping to reduce symptoms like pain and swelling in patients whose conditions have not responded to other treatments.
Study on the Effectiveness of Inebilizumab for Patients with IgG4-Related Disease
This international study, conducted in France, Germany, Netherlands, Spain, Italy, and Poland, is testing inebilizumab, a monoclonal antibody medication, for preventing disease flares in patients with IgG4-related disease.
Main inclusion criteria: Participants must be adults old enough to give legal consent in their region. They must have a clinical diagnosis of IgG4-related disease and meet the 2019 ACR/EULAR classification criteria. Patients must be currently experiencing or have recently experienced a flare requiring glucocorticoid treatment, and have the condition affecting at least two different organs. Male participants must use condoms with spermicide, and female participants who can become pregnant must use highly effective birth control.
Main exclusion criteria: Patients who have a different condition than IgG4-related disease, those not within the specified age range, and those not part of the specified clinical trial groups cannot participate.
Focus and goal: The study evaluates how effective inebilizumab is in reducing the risk of disease flares, which are sudden worsening of symptoms. The trial is designed as a double-blind study, meaning neither participants nor researchers know who receives the actual medication or placebo. Participants will receive regular check-ups and monitoring throughout the study, which runs until November 2028.
Investigational drug: Inebilizumab is a monoclonal antibody given through intravenous infusion. It works by targeting and depleting B cells, a type of white blood cell involved in the immune response, which helps reduce inflammation and potentially control the disease.
Study on the Effects of Obexelimab for Patients with IgG4-Related Disease
This extensive international trial, conducted in Spain, Netherlands, Italy, France, Germany, Espagne, Hungary, Poland, and Sweden, is investigating obexelimab for preventing disease flare-ups in patients with IgG4-related disease.
Main inclusion criteria: Participants must be at least 18 years old with a clinical diagnosis of IgG4-related disease. They must meet the 2019 ACR/EULAR Classification Criteria with a score of 20 or higher and have active signs or symptoms requiring starting or increasing glucocorticoid therapy. Patients must have been on glucocorticoid treatment for at least 3 weeks but no more than 6 weeks before starting the study, with a dose between 20 to 60 mg per day. Female participants must not be pregnant or breastfeeding and must agree to use contraception, while male participants must agree to use contraception or be surgically sterile.
Main exclusion criteria: Patients with other serious health conditions that could interfere with the study, those who are pregnant or breastfeeding, patients with recent infections requiring antibiotics, and those with a history of allergic reactions to similar medications are excluded. Patients currently participating in another clinical trial or who received an investigational drug within 30 days cannot participate.
Focus and goal: The study will last about a year, during which participants receive weekly subcutaneous injections of either obexelimab or placebo. The primary aim is to see if obexelimab can help prevent disease flare-ups after initial treatment with glucocorticoids. Safety and tolerability will be closely monitored throughout, with regular check-ups to assess health and treatment effects.
Investigational drug: Obexelimab is given as a weekly injection under the skin. It works by targeting specific immune cells to reduce inflammation and prevent the immune system from attacking the body’s own tissues, helping to prevent disease flare-ups.
Summary
The six ongoing clinical trials for IgG4-related disease reflect a diverse approach to managing this rare inflammatory condition. The trials are spread across multiple European countries, with the Netherlands participating in four studies, showing a particularly strong research focus in that region. Other countries including France, Germany, Italy, Spain, Poland, Hungary, Sweden, and Belgium are also contributing to this research effort.
The studies investigate several different therapeutic approaches. Three trials focus on biological medications that target the immune system: inebilizumab and obexelimab, which are monoclonal antibodies aimed at preventing disease flares, and abatacept, which targets immune cell activation. Two studies examine filgotinib, a JAK-inhibitor that blocks inflammation pathways, specifically for patients who have not responded to standard treatments. One unique trial focuses on improving diagnostic imaging methods using a novel PET/CT tracer.
Most trials require patients to meet the 2019 ACR/EULAR Classification Criteria for diagnosis and focus on patients with active disease. Common exclusion criteria across studies include pregnancy, active infections, and serious concurrent health conditions. Several trials specifically target patients with refractory disease, meaning those whose symptoms persist despite standard treatment approaches.
The research landscape shows a balanced emphasis between testing new biological therapies and exploring alternative treatment pathways through JAK-inhibitors, while also advancing diagnostic capabilities through improved imaging techniques.
