Clinical Trials for Kawasaki’s Disease
Currently, there is 1 ongoing clinical trial investigating new treatment approaches for Kawasaki’s disease. This trial is evaluating alternative treatments for patients who do not respond to standard initial therapy, comparing Anakinra with a second course of immunoglobulin treatment. The trial is being conducted in France and focuses on children who continue to have fever after their first treatment.
Clinical trial locations
Comparing Anakinra versus Immunoglobulin for Treatment-Resistant Kawasaki Disease in Patients Who Failed Initial Immunoglobulin Therapy
This clinical trial is designed for children with Kawasaki disease who did not respond adequately to their initial standard treatment. The study compares two different treatment approaches to help reduce fever and inflammation in these patients.
Who can participate:
- Children aged between 3 months and 18 years who weigh at least 5 kilograms
- Patients must have been diagnosed with Kawasaki disease, showing fever lasting 5 or more days along with at least 4 of these signs: changes in hands and feet, skin rash, red eyes without discharge, red and swollen lips or mouth, or a swollen neck lymph node larger than 1.5 centimeters
- The child must have continued or returning fever of 38°C or higher within 24 to 48 hours after receiving the initial standard treatment
- The fever must have lasted between 5 and 11 days in total
- Written consent from the patient, parents, or legal guardian is required
- The patient must have health insurance
- Female patients who are of childbearing age must use effective contraception during the study
Who cannot participate:
- Children who have received biological medications targeting the immune system in the past 6 months
- Patients with known allergic reactions to IVIG or Anakinra
- Those with active bacterial infections, severe liver or kidney problems, or immunodeficiency disorders
- Children currently participating in other clinical trials
- Patients with a history of tuberculosis, active cancer, or previous severe allergic reactions to medications
- Those who are pregnant or breastfeeding
- Patients with other serious medical conditions that could interfere with the study
What the trial involves:
The main goal of this study is to find out which treatment works better at reducing fever in children whose first treatment did not help enough. After confirming that a child still has fever following the initial treatment, doctors will randomly assign them to receive either a second dose of intravenous immunoglobulin given through a vein, or Anakinra given as an injection under the skin.
During the study, the medical team will closely monitor the child’s temperature, especially during the first 48 hours after treatment begins. The doctors will check how well the treatment is working and watch for any side effects. Because Kawasaki disease can affect the heart’s blood vessels, doctors will use special heart ultrasound tests called echocardiograms to monitor the heart’s health throughout the study.
The follow-up period extends over 45 days, with check-ups at several key points. At 14 days, doctors will assess the disease activity and check for side effects. At 30 days, blood tests will measure inflammation levels. At the final visit on day 45, a complete evaluation including a heart ultrasound will be performed to assess the overall treatment outcome.
Investigational drugs being tested:
Anakinra is an injectable medication that blocks a protein called interleukin-1, which plays a role in causing inflammation. By blocking this protein, Anakinra helps reduce fever and inflammation. It will be given as an injection under the skin.
Intravenous Immunoglobulin (IVIG) is a treatment made from donated blood plasma that contains healthy antibodies from many donors. It is given through an intravenous line directly into the bloodstream. This therapy helps fight inflammation and supports the immune system.
Summary
Currently, there is one active clinical trial for Kawasaki’s disease, taking place in France. This trial specifically addresses an important clinical challenge: how to best treat children who do not respond to the standard first-line treatment. The study compares Anakinra, a biological medication that targets inflammation, with a second dose of immunoglobulin therapy. Both treatments are being evaluated for their ability to reduce fever and prevent complications, particularly those affecting the heart. This research is particularly relevant for the subset of patients who experience treatment-resistant disease, which can carry higher risks of complications if not managed effectively.
