Ongoing Clinical Trials for Bronchiolitis Obliterans Syndrome
This article provides information about 2 ongoing clinical trials investigating new treatment approaches for bronchiolitis obliterans syndrome. These studies are examining medications that may help manage this challenging lung condition, particularly in patients who have undergone transplantation.
Clinical trial locations
- Austria
- Belgium
- Germany
- Greece
- Italy
- Netherlands
- Spain
Comparison of Tacrolimus alone versus Tacrolimus, Mycophenolate mofetil and Prednisone combination in elderly kidney transplant patients to reduce infections
This study focuses on elderly patients who have received a kidney transplant and examines different approaches to preventing organ rejection while reducing the risk of infections. The trial is being conducted in the Netherlands.
Who can participate: The trial is accepting patients who are 60 years of age or older and are receiving either a deceased donor or living donor kidney transplant. Both men and women can participate, including those who have had previous kidney transplants. However, patients must not have donor-specific anti-HLA antibodies at the time of transplantation. Participants must be able to understand and sign a written informed consent document.
Who cannot participate: The study excludes patients below 18 years or above 65 years of age, as well as those with previous organ transplants other than the current kidney transplant. Other exclusion criteria include active or chronic infections, current pregnancy or breastfeeding, known allergies to immunosuppressive medications, and severe heart, liver, or lung disease. Patients with active cancer or a history of cancer in the past 5 years, uncontrolled diabetes, mental conditions affecting study compliance, or those who have participated in other clinical trials within the past 30 days are also excluded. Additional exclusions include substance abuse history within the past 2 years, severe kidney dysfunction despite transplantation, and organ rejection episodes in the past 6 months.
Study focus: The main goal is to determine whether using tacrolimus alone works better than the standard treatment combining three medications: tacrolimus, mycophenolate mofetil, and prednisone. Researchers want to find out if using fewer medications can reduce infection risks and improve quality of life in older transplant recipients. The study will follow participants for three years, monitoring infection occurrence, kidney function, and overall patient wellbeing through regular medical tests.
Investigational drug: The study examines tacrolimus, an immunosuppressive medication that helps prevent organ rejection after kidney transplantation by weakening the immune system’s response to the transplanted kidney. This medication is being tested as a single-drug therapy approach, compared to the standard triple immunosuppressive therapy that combines three different medications.
Continued Treatment Study for Patients with Myelofibrosis, Post-Lung Transplant BOS, or Chronic Graft-Versus-Host Disease Using Itacitinib
This clinical trial provides continued treatment for participants who have been previously enrolled in studies involving the medication itacitinib. The study addresses multiple conditions including myelofibrosis, bronchiolitis obliterans syndrome following lung transplant, and chronic graft-versus-host disease. The trial is being conducted across multiple European countries including Belgium, Austria, Spain, Greece, Germany, and Italy.
Who can participate: Participants must be currently enrolled and receiving treatment in an Incyte-sponsored itacitinib-based clinical study. They should be tolerating the treatment well and receiving clinical benefit from it, as determined by the study doctor. Patients must demonstrate compliance with their previous study requirements and be willing to attend all scheduled visits and follow the treatment plan. Participants must also be willing to avoid pregnancy or fathering children based on specific criteria and must be able to understand and sign an informed consent form.
Who cannot participate: Patients who have not been receiving clinical benefit from itacitinib-based therapy in an Incyte-sponsored clinical study are excluded. Additionally, those who have not been part of an Incyte-sponsored clinical study using itacitinib-based therapy cannot participate.
Study focus: The purpose is to continue evaluating the safety of itacitinib for participants who are experiencing clinical benefits from this treatment. The study aims to provide a seamless transition for those who have been benefiting from itacitinib in previous trials, allowing them to continue their treatment under careful observation. Throughout the study, participants will have scheduled visits to ensure their treatment is progressing safely and effectively, with monitoring of any side effects or adverse events. The study is expected to run until 2027, ensuring long-term support and monitoring for participants.
Investigational drug: Itacitinib is a medication being studied for its potential to help people with bronchiolitis obliterans syndrome and other conditions. It is taken orally in tablet form and works by targeting specific pathways in the body involved in inflammation and immune responses. At the molecular level, itacitinib inhibits enzymes called Janus kinases, which play a role in regulating immune responses and inflammation. The medication is classified as a JAK inhibitor.
Summary
Currently, there are 2 ongoing clinical trials for bronchiolitis obliterans syndrome, offering different therapeutic approaches depending on the patient’s specific situation. One trial focuses on patients who have developed the condition following lung transplantation and is available across six European countries, providing broad geographic access. This study involves continued treatment with itacitinib, a JAK inhibitor that targets inflammation and immune responses.
The second trial, conducted in the Netherlands, addresses transplant-related complications more broadly, including bronchiolitis obliterans syndrome, by examining immunosuppressive medication strategies in elderly kidney transplant recipients. This research may provide insights relevant to managing immune system complications that can lead to various post-transplant conditions.
Both trials emphasize careful monitoring and long-term follow-up, reflecting the chronic nature of bronchiolitis obliterans syndrome and the need for ongoing medical support. Patients interested in participating should discuss eligibility criteria with their healthcare providers to determine which trial might be most appropriate for their individual circumstances.
