To demonstrate the superiority of baricitinib versus placebo in the preservation of beta-cell function, as measured by C-peptide, in younger adult and pediatric participants with new-onset T1D after 52 weeks of treatment
This is a phase III clinical trial to study if oral Baricitinib given daily for 52 weeks can preserve beta-cell function in participants with new onset type 1 diabetes.
Diagnosed with T1D within 100 days At least 8kg of body weight Ages 1-35 Otherwise healthy 1. Participant must be individuals age1 to <36 years of age, at the time of signing the informed consent. 2. Have a new diagnosis of T1D according to ADA criteria (ADAPPC 2025a) within 100 days prior to starting study intervention. 3. Have at least one diabetes-related autoantibody obtained at screening. The following qualifying autoantibodies will be confirmed through the central lab. a. GADA b. IAA c. IA-2A d. ZnT8A 4. Have evidence of residual cell function as indicated by stimulated (peak or 90 min) Cpeptide ≥0.2 nmol/L (0.6 ng/mL) during a 2-hour MMTT at Screening Visit 2. 5. Wear the study-provided CGM continuously during the study (participants at least 2 years of age): 6. Have a body weight ≥8 kg at screening. 7. Individuals of childbearing potential and individuals not of childbearing potential may participate in this trial. Compliance with contraception is required. 8. Are capable of giving signed informed consent 5.2. Exclusion Criteria 9. Have uncontrolled arterial hypertension as determined by the investigator and characterized by: Participants < 18 years: repeated systolic or diastolic blood pressure >95th percentile based on age, sex, and height (Flynn et al. 2017) Participants ≥18 years of age: repeated systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg in a seated position 10. Have experienced any of the following: Participants ≥18 years of age: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure or Participants <18 years of age: Stage III/IV heart failure according to Modified Ross Heart Failure Classification 11. Have a history of VTE or are considered at high risk of VTE as deemed by the investigator, or who meet both of the following criteria: BMI >35 kg/m2 and Combined oral contraceptive use 12. Have a history or presence (within 4 weeks of screening) of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking study intervention or interfere with the interpretation of data. 13. Have a history of lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including clinically suspicious lymphadenopathy or splenomegaly; or have a malignancy risk factor (for example, current malignancy or history of malignancy) Exception for participants ≥18 years of age: Participants with cervical carcinoma in situ that has been successfully treated with no evidence of recurrence or metastatic disease for at least 3 years may enroll in the study. Participants with basal cell or squamous cell skin cancers that have been successfully treated with no evidence of recurrence for at least 3 years may enroll in the study. 14. Have had any major surgery within 4 weeks prior to screening or will require major surgery during the study that, in the opinion of the investigator in consultation with Sponsor medical designee, would pose an unacceptable risk to the participant. 15. Have any serious medical condition within 4 weeks of screening that places the participant at an unacceptable risk if the participant were to participate in the study or confounds the ability to interpret data from the study, including, but not limited to, symptomatic cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine, hematological and neurological conditions or psychiatric illness/social situations that would limit compliance with study requirements. 16. Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection, including but not limited to the following:
Protocol Number: 26-0145
Principal Investigator