Phase 3 Type 1 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 1 to 25 years old at the time of signing the consent form
• People who have been diagnosed with Stage 3 Type 1 Diabetes (T1D) according to 2025 American Diabetes Association criteria
• People who are able to start the study treatment within 8 weeks (56 days) of their Stage 3 T1D diagnosis
• People who test positive for at least one diabetes-related immune marker (called an autoantibody) at the screening visit — these markers include GAD-65, IA-2, ZnT8, islet cell cytoplasmic autoantibodies (ICAs), or insulin antibodies (if tested within 14 days of starting insulin therapy)
• People who have a blood test result showing their pancreas is still producing a minimum level of insulin (C-peptide level of at least 0.2 nmol/L) at screening
• Both male and female participants are eligible
• Female participants who are not pregnant and are either unable to have children, or who agree to use a highly effective form of contraception (with less than 1% failure rate) during the study and for at least 30 days after the last dose
• Female participants of childbearing potential who have a negative pregnancy test at screening and within 24 hours before the first dose
• Female participants who are breastfeeding and agree to stop breastfeeding and discard breast milk during the study and for 20 days after the last dose
• People who are able to give informed consent; for participants who are minors, a parent or legal guardian must also sign the consent form

Who may not be able to join:

• People who have a type of diabetes other than autoimmune Type 1 Diabetes — for example, genetic forms of diabetes, MODY, diabetes caused by medication or surgery, or Type 2 Diabetes (as determined by the study doctor)
• People who have a serious active infection or a fever of 38.5°C (101.3°F) or higher in the 48 hours before the first dose (unless it is a localised skin infection), or who have a long-term, recurring, or hard-to-treat infection
• People who show signs of a current active infection with Epstein-Barr virus (EBV) or cytomegalovirus (CMV) at screening
• People who test positive for HIV, hepatitis B, or hepatitis C at screening
• People who have signs of active or latent tuberculosis (TB), based on medical history, chest X-ray, or TB blood test
• People who have other autoimmune diseases such as rheumatoid arthritis, multiple sclerosis, or lupus — though people with stable autoimmune thyroid disease or well-controlled coeliac disease may still be considered at the study doctor's discretion
• People who have any significant medical finding during screening that the study doctor believes could make it unsafe to participate or affect the study results
• People who have received a live vaccine (such as for chickenpox, measles, or mumps) within 8 weeks before the first dose, or who plan to receive one during treatment or within 26 weeks after the last dose
• People who have received an inactivated or mRNA vaccine within 2 weeks before the first dose, or who plan to receive one during treatment or within 6 weeks after the last dose
• People who are currently using or have used (within 30 days before screening) any blood sugar-lowering medication other than insulin
• People who have used treatments known to significantly affect the immune system or the course of Type 1 Diabetes — such as steroids for more than 14 days, or certain hormonal treatments — within 30 days before screening
• People who have used immune-suppressing or immune-modifying medicines, including certain biologic therapies, within 3 months or 5 half-lives (whichever is longer) before the first dose
• People who are currently using or have recently used (within 30 days before screening) any medication known to significantly affect blood sugar levels, such as certain antipsychotics or niacin
• People who have previously received teplizumab or any other anti-CD3 treatment
• People who are taking other medications that may not be compatible with the study drug, at the study doctor's discretion
• People who are currently enrolled in another clinical study, or who received an investigational treatment within the last 8 weeks or 5 half-lives (whichever is longer) before screening
• People whose blood test results at screening fall outside acceptable ranges for white blood cells, platelets, red blood cells, or liver function markers — specific thresholds apply and the trial site can confirm details (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.