JAK Inhibitors to Preserve C-Peptide Production in New Onset T1D: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subtype-Selective JAK Inhibitors for Preservation of Pancreatic β Cell Function in Newly Diagnosed Type 1 Diabetes Mellitus

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This phase 2 trial is a double-blind, randomized, placebo-controlled clinical trial in male and female adolescent and adult participants (ages 12-35 years) with newly diagnosed Stage 3 T1D (within 100 days of diagnosis). Enrollment into abrocitinib and ritlecitinib arms and the shared placebo arm will occur in a 1:1:1 allocation with a planned enrollment of 26 participants in each arm. Participants will receive 12 months of active treatment with abrocitinib, ritlecitinib, or placebo with up to 12 months of additional follow-up. A total sample size of 52 participants will receive active treatment, and a total of 26 participants will receive placebo.


Child to Adult


Diagnosed with T1D within 100 days of the baseline visit, ages 12-35 years, positive results for ≥1 islet autoantibodies, peak C-peptide of ≥0.2 pmol/mL after mixed-meal tolerance test (MMTT), and body weight ≥ 35 kg

Potential participants must meet all of the following 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 - Study #: 20230453 Effective Date: 7/25/2023 TrialNet Protocol TN31 Protocol Version: May 31, 2023 Page 16 of 56 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; GAD65A, 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 CGM 9. Participants who are CMV and/or EBV seronegative at screening must be CMV and/or EBV PCR negative within 30 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 30 days of the baseline visit (V0). 10. Be up to date on recommended immunizations; participants are required to receive killed influenza vaccination at least 2 weeks prior to the baseline visit (V0) when vaccine for the current or upcoming flu season is available. Enrollment must be delayed at least 4 weeks from administration of a killed vaccine other than influenza and 6 weeks from a live vaccination. Vaccinations should not be given while on study drug and be postponed at least 3 months after the last dose of study drug. Participants are required to be fully vaccinated including eligible boosters and should receive an authorized non-live COVID-19 vaccination series or COVID-19 vaccine at least 2 weeks prior to the baseline visit (V0). 12. If participant is female with reproductive potential, she must have a negative pregnancy test at screening and be willing to avoid pregnancy using a highly-effective contraceptive method for the duration of the study 13. Males of reproductive age must use a highly-effective contraceptive method during the treatment phase and for 3 months following last dose of study drug Potential participants must not meet any of the following exclusion criteria: 1. Current or ongoing use of non-insulin pharmaceuticals or medication that affect glycemic control or glucose homeostasis within 7 days prior to screening or any prohibited concomitant medication listed in section 4.8 2. Untreated hypothyroidism or active Graves’ disease 3. Concurrent treatment with other immunosuppressive agents (including biologics or steroids), other than inhaled or topical glucocorticoids 4. Active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 1 month prior to Day 0 or superficial skin infection within 1 week prior to Day 0 5. Active acute or chronic infection requiring treatment with intravenous therapy (IV) within a minimum 1 month prior to Day 0 a. Specific cases should be reviewed by Infectious Disease Committee prior to enrollment 6. Have active signs or symptoms of acute infection at the time of the baseline visit (V0). 7. Significant trauma or major surgery within 1 month of signing informed consent. Considered in imminent need for surgery or with elective surgery scheduled to occur during the study 9. History of disseminated herpes zoster or disseminated herpes simplex or a recurrent (more than one episode of) localized, dermatomal herpes zoster 10. Have evidence of prior or current tuberculosis infection as assessed by Purified Protein Derivative (PPD), interferon gamma release assay (IGRA) or by history 11. Have evidence of current or past HIV or Hepatitis B infection 12. Have evidence of active Hepatitis C infection

Type of Study



Barbara Davis Center
University of Colorado Hospital

Principal Investigator
Photograph of Andrea Steck,  MD

Andrea Steck, MD

Study ID

Protocol Number: 23-0996

More information available at ClinicalTrials.gov: NCT05743244

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