Janus Kinase (JAK) Inhibitors to Preserve C-Peptide Production in New Onset Type 1 Diabetes (T1D)

A multi-center, placebo-controlled, double blind, 1:1:1 randomized control clinical trial testing two different JAK Inhibitors abrocitnib, ritlecitinib, and placebo in subjects with recent onset Stage 3 Type 1 Diabetes within 100 days of diagnosis.

Inclusion Criteria: 1. Provide informed consent or assent as appropriate and, if \< 18 years of age have a parent or legal guardian provide informed consent 2. Age 12-35 years (both inclusive) at the time of signing informed consent and assent 3. Diagnosis of T1D within 100 days of the baseline visit (V0). 4. Positive for at least one islet cell autoantibody; Glutamate decarboxylase (GAD)65A, mIAA (if obtained within 10 days of the onset of insulin therapy), IA-2A, ICA, or ZnT8A 5. Stimulated C-peptide of ≥0.2 pmol/mL measured during mixed-meal tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes 6. HbA1c ≤ 10 % 7. Body weight ≥ 35kg at screening 8. Willing to comply with intensive diabetes management and wear a Continuous Glucose Monitoring Device (CGM) 9. Participants who are Cytomegalovirus (CMV) and/or Epstein-Barr virus (EBV) seronegative at screening must be CMV and/or EBV Polymerase chain reaction (PCR) negative within 37 days of randomization and may not have had signs or symptoms of a CMV and/or EBV-compatible illness lasting longer than 7 days within 37 days of the baseline visit (V0). 10. Participants who are CMV and/or EBV seropositive at screening must be CMV PCR negative and/or EBV PCR \160 mg/dL 10. Troponin I above the upper limit of normal 22. Vaccination with a live virus within the last 6 weeks and killed vaccine within 4 weeks (except 2 weeks for flu vaccine and COVID vaccine) 23. Be currently pregnant or lactating or anticipate becoming pregnant during the study 24. Male participants able to father children and female participants of childbearing potential who are unwilling or unable to use 2 effective methods (at least 1 highly effective method) of contraception, including abstinence, as outlined in this protocol for the duration of the study and for at least 3 months after the last dose of investigational product 25. Be currently participating in another T1D treatment study 26. Have had previous clinical use of Tzield (Teplizumab) not part of a T1D treatment study. 27. Have hearing loss with progression over the previous 5 years, or sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other auditory condition that is considered acute, fluctuating, or progressive a. Participants with hearing aids will be allowed to enter the study provided their hearing impairment is considered controlled/clinically stable. 28. Acute coronary syndrome (e.g., myocardial infarction, unstable angina pectoris) and any history of cerebrovascular disease within 24 weeks before screening; Heart failure NYHA (New York Heart Association) III, NYHA IV 29. ANY of the following conditions at screening: a. Screening 12-lead electrocardiogram (ECG) that demonstrates: i. Clinically significant abnormalities requiring treatment (eg, acute myocardial infarction, serious tachy- or brady-arrhythmias) or indicating serious underlying heart disease (eg, cardiomyopathy, Wolff-Parkinson- White syndrome); ii. Confirmed QT corrected using Fridericia's correction factor (QTcF) prolongation (\>450 milliseconds). b. Long QT Syndrome, a family history of Long QT Syndrome, or a history of Torsades de Pointes (TdP). 30. History of chronic alcohol abuse or intravenous drug abuse or other illicit drug abuse within 2 years prior to screening 31. Current or past use of tobacco or nicotine containing products more than the equivalent of 5 cigarettes per day 32. Participant is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the trial 33. Have any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct, or cause increased risk 34. Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results