The study aims to find out whether frexalimab can protect insulin-producing cells and improve blood glucose control in young people who were diagnosed with type 1 diabetes within the last 3 months.

You/your teen may be eligible for this study if you meet the following criteria.

Inclusion Criteria:

• Ages 12-21
• Diagnosed with type 1 diabetes within the last 3 months
• Not receiving any treatment for type 1 diabetes other than insulin therapy
• Not pregnant or breastfeeding

• First, you will complete a phone screening to confirm eligibility.

• If eligible, you will attend a screening visit at the Barbara Davis Center.

• The first treatment visit lasts 6 to 8 hours and includes a mixed meal tolerance test (MMTT) and an infusion of frexalimab or placebo.

• You will return every two weeks for injections until week 6. After that, injections may be done at home.

• You will come to the clinic about every three months for safety checks, study tests, and to receive medication.

• Study procedures may include MMTTs, physical exams, and blood and urine collection.

• After the treatment period ends, you will return for safety follow up visits every three months for about six months.

Participants can receive up to $2730 for completing all study visits. You may also receive mileage reimbursement and, if traveling from more than 50 miles away, a free hotel stay. Participants receive a snack at fasting visits, consultations with a diabetes educator and physician at each visit, and intensive diabetes management throughout the study.

There is no cost for you to participate in our research study.