Clinical Study: Type 1 Diabetes (T1D)

Study Summary

This study is testing an investigational drug called frexalimab in adolescents and adults age 12-35 years old with newly diagnosed type 1 diabetes who are on insulin therapy (adults age 18-35 will be enrolled first, followed by 12 to 21-year-olds later in the study).

You will be put into a group by chance (randomized) to receive either the study drug, frexalimab or placebo. The placebo looks just like frexalimab but does not contain any real medicine. It is used to better see if the effect of the study drug (frexalimab) in comparison to no medicine. Your chances of receiving frexalimab is 2 in 3.

You can help researchers understand:

• If frexalimab can preserve the body’s own insulin production.
• If frexalimab can help the body control blood glucose levels.
• If frexalimab can decrease the dose of insulin.
• How safe frexalimab is.

Eligibility Criteria

To be considered for this study you must be:

• Age 12-35 (adults age 18-35 will be enrolled first, followed by 12 to 21-year-olds later in the study)
• Recently diagnosed with type 1 diabetes and taking insulin replacement therapy for 90 days or less.

What will study participants be asked to do?

You will be in the study for about 135 weeks (2.5 years). You will visit the study site about 14 times for tests and health checks. Your study team will also call you between visits to see how you’re doing. Your health will be monitored for any side effects that may happen.