IMPACT Study

Open to recruitment

impact study link image

A Phase IIa, randomized, double-blind placebo-controlled, dose comparison, multi-centre adaptive design 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 18 to 44.

Recruiting sites:

Open to recruitment:

  • Oxford
  • Cardiff
  • Cambridge
  • Exeter
  • Newcastle
  • London – Guys and St Thomas’
  • London – Royal London Hospital
  • London – St Georges
  • Leeds
  • Leicester

Opening Soon:

  • Edinburgh

Summary

Trial of a new medication in people with type 1 diabetes, for people aged 18 to 44. Screening visit to be conducted within 9 weeks of diagnosis.

Aim

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

  • Aged 18 to 44 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 18 to 44 years.

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 11 study visits, including screening and randomisation visits, over a period of approximately 52 weeks.

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