You will be in the study for about 2.5 years (135 weeks).

You will have about 14 study visits in total for tests and health checks. The study team will also call you between visits to check on your health.

There is some evidence that adding Frexalimab to standard treatment for T1D may preserve the function of insulin-producing beta cells. Preserving the body’s ability to produce insulin can help to better regulate blood sugar and allow for a lower dose of insulin therapy, potentially reducing the risk of hypoglycemia. However, because this study is experimental, it is not known if you will directly benefit from participating. Even if you do not directly benefit, what we learn from this study may help other people with T1D in the future.

The global healthcare company Sanofi is sponsoring the FABULINUS Study.

Being in the study is voluntary. If you decide to join and then change your mind, you can leave the study at any time.

There will be no cost to you for the investigational study drug (or placebo), visits, tests, or supplies that are required for the study.

You will be placed by chance into a group to receive either the investigational Study Drug Frexalimab or placebo. You are 2 times more likely to receive the investigational drug than the placebo. A computer is used to assign participants to study treatment groups by randomization.

You will also continue taking your insulin therapy as recommended by your doctor.

A computer is used to assign participants to study treatment groups by chance. This is called randomization.

Investigational study drug means that it potentially can treat certain disease but is currently not approved to be used to treat this disease. However it is allowed to be used for clinical research purposes.

Frexalimab binds to a specific marker on the surface of immune cells responsible for destroying insulin-producing cells in the pancreas. Researchers want to see if the study drug can stop or reduce damage to these cells, and therefore preserve the body’s own insulin production. Watch a video on what happens in type 1 diabetes and how frexalimab may be able to help.

People with type 1 diabetes can no longer make enough insulin, so they must take replacement therapy by injection or continuous infusion every day for the rest of their lives. Frexalimab may help to preserve the body’s ability to produce some insulin. Researchers want to see if this can reduce the amount of replacement insulin needed. Throughout the study you will continue taking your insulin therapy as prescribed.

Side effects are health problems that may happen to a participant after starting the study. These health problems are called “side effects” if the study doctor thinks they might be related to the study treatment. During the course of the study, you have to inform the study doctor or study staff, as soon as possible, of any side effects or health problems even if you do not think they are caused by the study treatment. Talk to your study doctor for more information on possible side effects.