IMPACT Study

Open to recruitment

impact study link image

A Phase Ib/IIa, randomized, double-blind placebo-controlled, multicenter 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 young adult and adolescent patients with a recent onset Type 1 diabetes.

Protocol number: IMCY-T1D-003

Recruiting until: Study recruitment is currently open to adult patients aged 18-45 . Recruitment of adolescent patients will start at a later stage (step 2).

Recruiting sites:

Open to recruitment:

  • Oxford

Opening Soon:

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

Summary

Trial of a new medication in people with type 1 diabetes, currently for people aged 18-45. Screening visit to be conducted within 9 weeks of diagnosis.

Aim

The study aims to investigate the best dose and number of doses to confirm whether the medication is effective when used in the best regimen. The study will investigate treatment specific biomarkers and the effect of study medication on beta-cell function in adults and adolescents with recently diagnosed type 1 diabetes.

Eligibility to take part

  • Age 18-45 years (Step 1 of the study – currently recruiting) and age 12-45 years (Step 2 of the study which will recruit at a later stage)
  • Diagnosed with type 1 diabetes (first insulin treatment) within 9 weeks of study screening visit
  • At least one diabetes-related autoantibody
  • HLA DR4 positive
  • 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 designed to be conducted in two steps: Step 1 is now open for participation and will include 24 patients aged 18-45 who will be randomised 1:1:1 to treatment with 450 μg IMCY-0098 or 1350 μg IMCY-0098 or placebo, at 2-weekly intervals, for 6 treatments.

Step 1 patients will undergo 10 study visits, including screening and randomisation visits, over a period of approximately 52 weeks.

The main outcome of step 1 will be to identify the number of treatments and the dose of IMCY-0098 to be used in the second step of study which will recruit at a later stage and include 60 participants in two sub-groups (patients aged 12-17 and those aged 18-45).

Who is running this study?

The study sponsor is Imcyse SA. The study is being conducted with the support and endorsement of INNODIA.

The hospitals listed below are participating in the study:

  • Oxford Centre for Diabetes, Endocrinology and Metabolism, Churchill Hospital, Oxford
  • Addenbrookes Hospital, Cambridge
  • University Hospital of Wales, Cardiff
  • Royal Devon and Exeter Hospital, Exeter
  • Royal London Hospital, London
  • Guys and St. Thomas’ Hospital, London
  • George’s Hospital, London
  • Royal Victoria Infirmary, Newcastle

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