Phase 1 study of IMCY-0098 in Recent Onset Type 1 Diabetes
Research type
Research Study
Full title
A PHASE I, PLACEBO CONTROLLED, DOUBLE-BLIND, DOSE ESCALATION CLINICAL TRIAL TO EVALUATE THE SAFETY AND IMMUNE RESPONSES OF IMCYSE's IMCY-0098 IN PATIENTS WITH RECENT ONSET TYPE 1 DIABETES.
IRAS ID
220388
Contact name
Richard David Leslie
Contact email
Sponsor organisation
Imcyse SA
Eudract number
2016-003514-27
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This is a Phase 1 randomised double-blind study, comparing two investigational products; one of them is IMCY-0098 and the other one is placebo in participants with recent onset Type 1 Diabetes.
Diabetes is a lifelong condition that causes a person's blood sugar (glucose) level to become too high.
In most people with type 1 diabetes, the body's own immune system — which normally fights harmful bacteria and viruses — mistakenly destroys the insulin-producing (islet) cells in the pancreas. IMCY-0098 is a synthetic peptide (small protein), made in the laboratory which acts through the body's immune system. It is being developed to stop the immunological destruction of insulin-producing cells. It acts like a vaccine and creates new cells that will specifically destroy those cells of the body’s own immune system that mistakenly destroy the insulin-producing (islet) cells in the pancreas. IMCY-0098 is therefore an immunotherapeutic agent that could potentially prevent and cure diseases mediated by inadequate immune responses such as type 1 diabetes.
To increase the immune response to IMCY-0098, the solution with the peptide will also contain aluminium hydroxide. Aluminium hydroxide is present in almost all vaccines used for routine immunisation of infants, children and adults.
The main purpose of this study is to collect information on the safety of IMCY-0098 in participants with recently diagnosed Type 1 diabetes. The study will also assess if IMCY-0098 has an effect on the clinical signs of diabetes such as blood sugar levels. Tests will also be done on specific blood cells (called lymphocytes) to see if IMCY-0098 has a positive effect on the immune system. This study is to include around 40 participants, including approximately 8 in United Kingdom. The study duration will be 24 weeks for each participant enrolled.
REC name
London - Chelsea Research Ethics Committee
REC reference
17/LO/0633
Date of REC Opinion
9 Jul 2017
REC opinion
Further Information Favourable Opinion