A Phase IIa, randomized, double-blind, dose comparison, placebo-controlled, multi-centre clinical trial to evaluate the immune signature of the treatment with the Imotope™ IMCY-0098 and its effect on the preservation of beta-cell function in adult patients with a recent onset Type 1 diabetes.
Protocol number: IMCY-T1D-003
Recruiting until: Study recruitment is open to adult patients aged at least 18 and less than 45.
Open to recruitment:
- London – Guys and St Thomas’
- London – Royal London Hospital
- London – St Georges
Trial of a new medication in people with type 1 diabetes, for people aged at least 18 and less than 45. Screening visit to be conducted within 9 weeks of diagnosis.
The study aims to investigate the effect of two doses of IMCY-0098 upon treatment-specific biomarkers and the effect of study medication on beta-cell function in adults with recently diagnosed type 1 diabetes.
Eligibility to take part
- Age at least 18 and less than 45 years
- Diagnosed with type 1 diabetes (first insulin treatment) within 9 weeks of study screening visit
- At least one diabetes-related autoantibody
- HLA DR4 positive (or HLA DR4 negative, HLA DR3 positive for the sub-study)
- Insulin treatment
- Random C-peptide ≥200 pmol/L at screening
If you are interested in taking part, please click the “Get Involved” button below:
What will I be asked to do?
This study is open for participation patients aged at least 18 and less than 45.
The main study will include 84 patients who are HLA DR4 positive. Patients will be randomised 1:1:1 to treatment with 450 μg IMCY-0098 or 1350 μg IMCY-0098 or placebo.
The sub-study will include 24 patients who are HLA DR4 negative, but HLA DR3 positive. These patients will be randomised 1:1 to receive treatment with 450 μg IMCY-0098 or 1350 μg IMCY-0098.
All patients will undergo 13 study visits, including screening and randomisation visits, over a period of approximately 2 years.