Development of a new drug therapy for the treatment of Graves’ Disease.
A new drug is being assessed at UK hospital sites for the treatment for Graves’ disease.
The trial is funded by Apitope International NV and the European Commission through a Framework 7 grant and has been approved by the Central Research Ethics Committee and the Medicines and Healthcare Products Regulatory Agency (MHRA).
What causes Graves’ disease?
Graves’ disease is an autoimmune condition that involves antibodies causing the thyroid gland to produce too much thyroid hormone; this is called hyperthyroidism.
There are currently three different principle treatment options for Graves’ disease that may be recommended by your doctor. These include anti-thyroid medications such as carbimazole, radioactive iodine treatment and in some incidences surgery may be required.
What is the study Drug?
The study drug is made from a mixture of two substances called peptides that are found naturally in proteins in the body. The study drug is designed to alter the body’s immune response by stopping the production of the antibodies that have caused the thyroid disorder. This first study in humans will test whether this peptide therapy (the study drug) specifically designed for Graves’ disease, is safe and well tolerated. It is also designed to provide initial information on whether it can improve your body’s immune response and prevent a thyroid disorder from developing.
Who can take part?
Women and men who:
- Are aged 18-65
- Have a diagnosis of Graves’ Disease and are not taking anti-thyroid therapy and have not had either; thyroid surgery or radioactive iodine treatment.
- Are not pregnant, breastfeeding or attempting to conceive
Where is the study taking place?
- Queen Elizabeth Hospital Birmingham
- Kings College Hospital London
- Royal Victoria Infirmary Newcastle
- Cardiff, University Hospital of Wales
- The Christie Hospital Manchester
- Royal Devon and Exeter Hospital
- Leeds Teaching Hospital NHS Trust
- Imperial College Healthcare NHS Trust - London
When does the study start and end?
The trial started recruitment in September 2016 and is currently recruiting patients.
If you would like to take part but don’t live near one of these centres, you may still be eligible to join the trial. Please contact the Chief Investigator Professor Simon Pearce (email@example.com) for more information about a participating centre in your area.
Travel expenses will be covered and a patient inconvenience payment will be made during your participation in the study.
For further information on this trial please see: clinicaltrials.gov/ct2/show/NCT02973802