NCT07670650
PRISE (Personalized Response and Immunologic Surveillance of Endogenous C-Peptide Preservation in New, Recent, and Established Onset Type 1 Diabetes Treated With Human Anti-Thymocyte Globulin [h-ATG]) Study
Not Yet Recruiting
PHASE3Ages 5–40InterventionalTreatmentUniversity of FloridaInvestigator-initiated
~108 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:SAB-142Placebo
At a glance
Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Area under the concentration-time curve (AUC) of C-peptide after a 2 hour mixed meal tolerance test (MMTT)
Measured over Dose administration to 12 Months
Conditions
Where it's being run
4 sites across 4 statesCalifornia1
Colorado1
Florida1
Indiana1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
For Cohort 2: within \>100 days but \<1 year (365 days) of randomisation;
For Cohort 3: within ≥1 year (365 days) but \<2 years (730 days) of randomisation. For participants who were initially misdiagnosed with Type 2 diabetes (T2D), time from misdiagnosis with T2D to randomisation is up to 1 and 2 years.
Glutamic acid decarboxylase 65 (GAD65)
Islet antigen 2 (IA-2)
Zinc transporter 8 (ZnT8)
Insulin autoantibodies (if testing within the first 14 days of insulin treatment) 8. Female participants:
Exclusion
Lymphocyte count: \<1000/μL
Neutrophil count: \<1500/μL
Platelet count: \<100 000 platelets/μL
Haemoglobin: \<10 g/dL
Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): from 30 days before dosing through 6 months following administration of SAB-142 for each TP;
Recombinant, inactivated or otherwise "non-live" vaccines: from 30 days before dosing or within 60 days following dosing; or planned/required within 30 days prior to or 60 days following Day 1 of TP2.
Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): Within the 30 days before dosing or within 30 days following dosing; or planned/required within 30 days prior to or 30 days following Day 1 of each TP.
Recombinant, inactivated or otherwise "non-live" vaccines: Within the 30 days before dosing or within 30 days following dosing; or planned/required within 30 days prior to or 30 days following Day 1 of each TP. 18. Female is lactating and/or plans to lactate with the intent to provide her own breast milk to a baby at any point during the study. 19. An individual who has a history of alcohol, drug, or chemical abuse within 12 months prior to study screening (positive tetrahydrocannabinol is allowed) Note: Abuse is defined according to local, regional and/or country specific guidance. Participants who are tested positive for illicit substances but have a prescription medication to manage their concomitant conditions such as attention-deficit/hyperactivity disorder (ADHD) or others are allowed to participate in the study. 20. An individual who has a medical, psychological or social condition that, in the opinion of the Investigator, would interfere with safe and proper completion of the trial.
What this trial measures
- Area under the concentration-time curve (AUC) of C-peptide after a 2 hour mixed meal tolerance test (MMTT)Dose administration to 12 Months
This is a measure of endogenous insulin production and β cell function (change from baseline in C-peptide ln \[AUC+1\].