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Supporting clinical trials of ustekinumab

We are funding Professor Timothy Tree and his team at King’s College London to support clinical trials of ustekinumab in young people recently diagnosed with type 1 diabetes. The team is analysing blood samples from people taking part in the clinical trials USTEKID and UST1D2.
Content last reviewed and updated: 05.09.2023

Professor Tim Tree

What is ustekinumab?

Ustekinumab is an immune therapy, which is already used to treat other autoimmune conditions including Crohn’s disease and psoriasis. Previous research studies have shown that ustekinumab can dampen the immune attack that leads to type 1 diabetes. It works by reducing the levels of proteins that drive the immune attack on insulin-producing beta cells.

USTEKID clinical trial

USTEKID involves 72 adolescents aged 12-18 who were diagnosed with type 1 less than 100 days before they joined the study. The clinical trial took place at 16 sites across the UK.

Half the participants received an injection of ustekinumab every two months with seven doses in total. The other half received a non-active placebo in the same format. Neither the researchers nor the participants will know which they received until after the study has finished. This is called a double-blind trial.

Find out more about this clinical trial in this research paper. Recruitment has now finished, but you can learn one girl’s experience of taking part in the USTEKID clinical trial in our blog.

UST1D2 clinical trial

Participating in UST1D2 are 66 adults aged 18-35, who are also within 100 days of being diagnosed with type 1. UST1D2 has the same design as USTEKID to allow Tim to use the two studies for his research project. Researchers give the participants seven doses of either ustekinumab or a placebo every two months via an injection. Like USTEKID, this clinical trial is double-blind.

This trial is still recruiting participants in Toronto and Vancouver, Canada. Find out more about the UST1D2 study, including details of how to sign up.

Measuring the effectiveness of ustekinumab

After participants have received their treatment of ustekinumab or placebo for a year, Tim will measure the amount of insulin they can produce following a meal. He will compare the results of the ustekinumab group with the group who received a placebo.

If people can produce insulin in response to a meal, this could indicate that the treatment has preserved their beta cells. This will be one way of measuring how effective ustekinumab is for treating type 1.

Analysing blood samples

The team will look at which proteins are present in blood samples from the participants. This will determine whether ustekinumab has reduced the proteins involved in the immune attack on beta cells. The researchers will also look for any biological signs (known as biomarkers) that indicate whether the drug has worked or not.

How will this research help people with type 1?

The researchers hope that giving ustekinumab to people newly diagnosed with type 1 will reduce the immune attack on their beta cells. This should help to preserve the remaining beta cells and allow people with type 1 to keep making their own insulin. The more insulin people with type 1 can produce themselves, the less they’ll need to give themselves. This helps reduce hypos and make it easier to maintain stable blood sugar levels.

Tim’s project is vital for measuring how well ustekinumab can treat type 1. In the future, any biomarkers Tim identifies could enable scientists and clinicians to better monitor people taking ustekinumab. If the drug isn’t working in some people, this would allow clinicians to suggest alternative treatment options, which may be more effective for those individuals.

Is JDRF funding any other research like this?

We are funding the UST1D2 trial in Canada. USTEKID is part of the UK T1D Research Consortium, a clinical trials platform which we co-fund. Professor Tim Tree co-leads the Consortium with Professor Colin Dayan. We are also funding Professor Colin Dayan to establish another clinical trials platform, T1D Plus. This platform can test multiple immune therapies at the same time, including mixtures of different drugs.

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