Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults, Adolescents and Children on Top of Insulin Therapy (FABULINUS)

To be considered for this study, you would typically need to be between 12 and 35 years old. You must have been diagnosed with Type 1 Diabetes recently – specifically, within the last 90 days before your first screening visit – and already be on insulin treatment. Your doctors will also check for specific markers in your blood, confirming you have Type 1 Diabetes, and that your body is still producing at least a small amount of its own insulin.

There are also some reasons why you might not be able to join. For example, if you've had certain serious infections recently, or have a history of specific types of infections, you might not be eligible. The medical team will review your health history carefully to make sure the study is safe for you. You also need to be up-to-date with your routine vaccinations.

If you decide to take part, your total involvement in the study could last up to about 2 and a half years (135 weeks). Initially, there's a screening period of 3 to 5 weeks to see if you're a good fit. After that, you'll enter the main treatment period, which is for approximately two years (104 weeks). During this time, you'll either receive frexalimab or a placebo, in addition to your regular insulin, and will have regular check-ups and assessments.

After the main two-year treatment, there's an optional extra two-year period where you might know if you're receiving the active drug (this is called an Open Label Extension). Finally, there will be a follow-up period of up to 26 weeks to check on your health after the treatment ends. Throughout the study, you'll have regular hospital visits for blood tests, physical exams, and to receive your study medication. The exact number of visits will be explained by the study team.