Age
Child to Adult
Eligibility
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
kgPotential 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
