Phase 2 Type 1 Diabetes Trial, Recruiting

Written by an AI model from the 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 15 to 40 years old at the time of joining Part A of the trial, or aged 5 to 40 years old for Part B.
• People who weigh at least 16 kg at the time of joining.
• People who have been diagnosed with Type 1 diabetes within the last 100 days (including those initially misdiagnosed with Type 2 diabetes), where the date of diagnosis is counted from the first dose of insulin or other blood sugar-lowering medication.
• People whose blood test during screening shows a C-peptide level of at least 0.2 nmol/L — this is a measure of how much insulin the body is still producing (one retest is allowed if the first result is borderline).
• People who have completed all required blood samples during a specific meal-based test done during screening (called an MMTT).
• People whose screening blood tests show at least one of four specific markers linked to Type 1 diabetes: GAD65, IA-2, ZnT8, or insulin autoantibodies (the last one only if tested within the first 14 days of starting insulin).
• Female participants who are either not yet able to become pregnant (such as pre-pubertal girls who have not yet started menstruation, or those who have had surgical sterilisation or are post-menopausal), or who agree to use reliable contraception and have a negative pregnancy test before receiving the study drug.
• Male participants who are not surgically sterilised and who agree to use appropriate contraception during the study and not to donate sperm until the end of the study.
• People who agree to receive any age-appropriate vaccinations required in their country before starting the study drug.
• People who agree not to take part in other experimental treatments during the study, especially treatments that may affect the immune system or the insulin-producing cells in the pancreas.
• People who have suitable veins for blood tests.
• People who are willing and able to follow all study requirements and visit schedules.

Who may not be able to join:

• People with a known allergy or serious allergic reaction (including anaphylaxis) to antibody-based medicines, biological treatments, passive vaccines, pork products, or any ingredient in the study drug.
• People with a known allergy or sensitivity to any other medications required as part of the study.
• People who have taken part in another clinical trial involving an experimental drug, medical device, or vaccine within the 12 weeks before screening.
• People who have previously received teplizumab or any similar experimental immune-modifying anti-CD3 treatment at any point in the past.
• People with a significant uncontrolled medical condition affecting the kidneys, heart, blood vessels, lungs, digestive system, nervous system, blood, joints, cancer, mental health, or immune system that could affect safety or study results (confirm with trial site if a condition is stable and well-managed).
• People with an autoimmune disease other than Type 1 diabetes (such as rheumatoid arthritis, multiple sclerosis, or lupus) that is currently being treated with a systemic immune-suppressing medication — except for thyroid disease or coeliac disease that is stable and well-managed.
• People who frequently get infections, or who have chronic, recurring, or hard-to-treat infections such as certain fungal or respiratory infections.
• People who test positive for HIV, hepatitis B, or hepatitis C during screening.
• People with signs of active or past tuberculosis (TB), based on medical history, chest X-ray, or TB testing.
• People who have had a serious bacterial, viral, or fungal infection requiring hospitalisation or intravenous antibiotics, or who have a significant active infection, in the 30 days before or during screening.
• People with significant liver disease, or whose liver function blood tests during screening are notably above the normal range (confirm with trial site, as some retesting is allowed).
• People whose blood counts during screening fall below certain levels for white blood cells, platelets, or haemoglobin (confirm with trial site).
• People currently taking or who have recently taken medications known to significantly alter diabetes progression or immune function, such as systemic steroids (short courses may be acceptable — confirm with trial site), verapamil, or baricitinib.
• People currently taking or who have recently used any blood sugar-lowering medication other than insulin, such as metformin, sulfonylureas, or GLP-1 agonists.
• People currently taking or who have recently used medications known to significantly affect blood sugar levels, such as certain antipsychotic medications or niacin.
• People following or planning to follow a highly restrictive diet that could interfere with their health or the study drug's effects.
• People who have received a live vaccine (such as for chickenpox, measles, or flu nasal spray) within 30 days before the study drug dose or who plan to receive one within 60 days after dosing, or who have received any other type of vaccine (such as inactivated or recombinant vaccines) within 30 days before or 60 days after dosing.
• People who are currently breastfeeding or plan to breastfeed during the study.
• People with a history of alcohol, drug, or chemical misuse within the 12 months before screening (as defined by local guidelines), with some exceptions that may apply — confirm with trial site.
• People with a medical, psychological, or social condition that, in the opinion of the trial doctor, could prevent them from safely completing the study.
• People who are employees of the trial site or the investigating doctor and are directly involved in running the study.

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