Ongoing Clinical Trials for Autoimmune Disorders
Currently, there are 3 clinical trials investigating new treatment approaches for autoimmune disorders. These studies are exploring advanced therapies including CAR T-cell treatment, strategies for safely stopping steroid medications, and optimized dosing strategies for existing medications in children. The trials are taking place across Europe, including Italy, Germany, and the Netherlands.
Clinical trial locations
- Germany
- Italy
- Netherlands
Study on Anti-CD19 CAR T-Cell Therapy for Patients with Refractory Systemic Autoimmune Diseases Using Levetiracetam, Fludarabine, and a Drug Combination
This trial is investigating a new treatment called anti-CD19 CAR T-cell therapy for people with difficult-to-treat autoimmune diseases. The therapy uses a patient’s own immune cells that are modified in a laboratory to better fight the disease.
Who can participate: The study is recruiting adults between 18 and 64 years old who have received two doses of a COVID-19 vaccine within the last 6 months. Participants must be willing to use effective contraception for 12 months after treatment. They need to be able to follow the study visit schedule and understand the consent process.
Who cannot participate: The trial excludes patients with active, uncontrolled infections, a history of severe allergic reactions to similar treatments, or those who are pregnant or breastfeeding. People with cancer within the last 5 years (except certain skin cancers), unstable heart conditions, recent drug or alcohol abuse, or those currently participating in another clinical trial cannot join. Patients with any condition that study doctors believe would make participation unsafe are also excluded.
What the study involves: The treatment begins with medications to prepare the body, including levetiracetam and fludarabine given through an intravenous infusion. This is followed by cyclophosphamide to further prepare the immune system. The main treatment involves infusing modified T-cells that target specific immune cells involved in the disease process. After the cell therapy, patients receive tocilizumab to help manage potential side effects such as inflammation. Participants are closely monitored for up to 24 weeks, with long-term follow-up to assess safety and effectiveness.
Study goals: The trial aims to evaluate whether this therapy is safe and shows initial effectiveness in patients with systemic lupus erythematosus, systemic sclerosis, dermatomyositis/polymyositis, and antineutrophil cytoplasmic antibody-associated vasculitis. Researchers will monitor for side effects, changes in immune system function, and levels of disease-related antibodies in the blood.
Study on Stopping Prednisone for Patients with Inflammatory or Autoimmune Disorders
This trial is examining the best way to stop glucocorticoid (steroid) treatment in patients with inflammatory conditions. The study compares two approaches: stopping the medication immediately versus gradually reducing the dose over four weeks.
Who can participate: Adults 18 years or older who are currently taking at least 7.5 mg daily of a glucocorticoid medication similar to prednisone can participate. They must have been on this medication for at least 28 days and taken a total of at least 420 mg before joining the study. Importantly, their condition must no longer require gradual dose reduction for treatment purposes.
Who cannot participate: The trial has specific age requirements and excludes vulnerable populations such as children, pregnant women, or those with certain disabilities. Patients must meet all gender and age criteria specified in the study protocol.
What the study involves: After confirming eligibility and obtaining informed consent, participants are randomly assigned to either stop their glucocorticoid treatment immediately or taper it off over four weeks. The medication being studied is prednisone, taken orally. Throughout the study period of up to 28 days, participants are closely monitored for any health changes, including the need for additional treatment or serious health events. Participants also assess their own general health using a scale from 0 to 100.
Study goals: The primary aim is to determine whether stopping glucocorticoid treatment quickly is as safe and effective as slowly reducing the dose. Researchers will particularly watch for signs of adrenal insufficiency, a condition where the body doesn’t produce enough hormones after stopping steroid treatment. The study seeks to provide valuable information on the safest way to discontinue glucocorticoid therapy while ensuring patient well-being.
Study on Anakinra for Children with Systemic Juvenile Idiopathic Arthritis
This trial is exploring a new treatment strategy for systemic Juvenile Idiopathic Arthritis (sJIA), a type of arthritis affecting children. The study investigates whether using a blood marker called IL-18 can help guide treatment with anakinra, potentially reducing the number of injections needed.
Who can participate: Children and adolescents aged 8 months to 16 years diagnosed with sJIA can participate. Both boys and girls are eligible. For the treatment phase, patients must have been treated with anakinra as their first treatment and shown a positive initial response, meaning no fever by the seventh day of treatment. They must also achieve significant symptom improvement around 90 days after starting treatment. Parents or legal guardians must be willing to sign consent forms, and the child must also consent if old enough to understand.
Who cannot participate: The study excludes patients with other autoimmune conditions or joint disorders beyond sJIA, including Still’s disease or other types of systemic juvenile idiopathic arthritis.
What the study involves: Treatment begins with anakinra, a medication that helps reduce inflammation by blocking a specific protein in the body. It is given as an injection under the skin using a pre-filled syringe containing 100 mg/0.67 ml of solution. After monitoring the initial response, including checking that fever disappears within seven days, the study moves into a phase where the medication is gradually reduced and eventually stopped. The decision to reduce or stop treatment is guided by the IL-18 blood marker to ensure the disease remains inactive. Throughout the trial, participants are regularly monitored to assess how many injections are needed, any disease flares, the need for alternative treatments, and any side effects.
Study goals: The main goal is to determine the average number of anakinra injections needed to keep the disease inactive during the first year of treatment. The study also aims to find out how many children achieve remission without medication after one and two years. This approach may help reduce the treatment burden for patients while maintaining effective disease control.
Summary
These three clinical trials represent diverse approaches to managing autoimmune conditions across different age groups and disease types. The trials span three European countries, with each focusing on a distinct aspect of treatment optimization. The Italian study explores cutting-edge CAR T-cell therapy for adults with severe, treatment-resistant conditions. The German trial addresses a practical clinical question about safely discontinuing steroid therapy, which affects many patients with inflammatory conditions. The Netherlands study focuses on pediatric care, seeking to minimize treatment burden for children with arthritis while maintaining disease control.
A notable pattern is the emphasis on personalized treatment approaches, whether through biomarker-guided therapy in the pediatric arthritis study or comparing different medication withdrawal strategies. These trials reflect ongoing efforts to balance effective disease control with minimizing side effects and treatment burden for patients living with autoimmune conditions.
