IMC-S118AI-1007

Recruiting sites:

• Queen Elizabeth Hospital, Birmingham
• Salford Royal Hospital, Salford
• Guy’s Hospital, London
• Addenbrooke’s Hospital, Cambridge
• Churchill Hospital, Oxford
• Royal Hallamshire Hospital, Sheffield

Summary

The IMC-S118AI-1007 clinical research study is for people with T1D. This is the first time the study drug, called IMC-S118AI, is being tested in humans.

The primary focus is to confirm if IMC-S118AI is safe for the trial participants to use.

As a secondary goal, the study wants to see preliminarily how effective the study drug is at helping the body produce insulin.

Eligibility to take part

Main Inclusion criteria

You may be able to join if you meet the following criteria (other criteria will apply):

• Adults (18–45 years old)
  Part 1: T1D diagnosis within the last 5 years
  Part 2: T1D diagnosis within the last 6 months
• Adolescents (12–17 years old) T1D diagnosis within the last 6 months
• HLA-A*02:01-positive (the study can help you find out)

Main exclusion criteria

You may not be able to join if you meet the following criteria (other criteria will apply):

• Non-T1D (type 2 diabetes, monogenic diabetes, and secondary diabetes)
• History of recurrent hypoglycaemia due to non-adherence with insulin treatment
• Prior treatment with immunomodulating therapy for T1D
• Have a history of heart disease and reduced heart function
• Current diagnosis of cancer or any history of cancer

If you are interested in taking part, please click the “Get Involved” button below:

What will I be asked to do?

This study is divided into several parts. Some groups will get the study drug one time, and others will get the study drug multiple times over weeks and months. In some of the groups, people may receive the active study drug or a placebo (an inactive treatment) to compare the effect of the treatments.

Part 1 of the Study (currently recruiting): Participants will participate in a group that receives the active study drug one time.

Part 2 of the Study (Recruitment TBD): This part of the study has three groups. Some parts will include younger people (age 12-17).

Who is running this study?

This study is being run and funded by Immunocore Limited, a global biotechnology company.

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