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NCT07670650 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by University of Florida.
- Not yet
- Registry status
- Phase 3
- Development phase
- 108
- Enrollment target
NCT07670650: Clinical Trial Phase 3 study, sponsored by University of Florida.
NCT07670650 is a Phase 3 study that has not yet begun recruiting, run by University of Florida. The registered enrollment target is 108 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07670650, a Phase 3 study, has not yet begun recruiting, sponsored by University of Florida.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 108 participants
- Enrollment target
Study Summary
This Phase 3, multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety, and tolerability of SAB-142, a fully human anti-thymocyte globulin (h-ATG), in participants aged 5 to 40 years with Stage 3 type 1 diabetes (T1D). The study will enroll participants with recent-onset T1D (\>100 days to \<1 year from diagnosis) and established-onset T1D (≥1 year to ≤2 years from diagnosis) who retain residual beta-cell function as demonstrated by stimulated C-peptide levels \>0.2 nmol/L. Participants will be randomized in a 2:1 ratio to receive SAB-142 or placebo in addition to standard diabetes care. The primary objective is to determine whether SAB-142 preserves beta-cell function over 12 months as measured by stimulated C-peptide response during a mixed meal tolerance test (MMTT). External data from the SAB-142-201 SAFEGUARD study will be incorporated to include participants with new-onset T1D (\<100 days from diagnosis) in the primary efficacy analysis.
Primary Outcome
This is a measure of endogenous insulin production and β cell function (change from baseline in C-peptide ln \[AUC+1\].
Interventions
- DRUG Placebo
- DRUG SAB-142
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2026-09-01 |
| Est. Completion | 2030-09-01 |
| Phase | Phase 3 |
What is known before NCT07670650 opens enrollment
NCT07670650 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07670650 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07670650 about?
NCT07670650 is a clinical study titled "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". This Phase 3, multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety, and tolerability of SAB-142, a fully human anti-thymocyte globulin (h-ATG), in participants aged 5 to 40 years with Stage 3 type 1 diabetes (T1D). The study will enroll participants with...
What is the current status of trial NCT07670650?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 108 participants. The study started on 2026-09-01. Estimated completion is 2030-09-01.
What interventions are being tested in trial NCT07670650?
The interventions under investigation include: Placebo (DRUG), SAB-142 (DRUG).
Who is sponsoring clinical trial NCT07670650?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07670650's enrollment target sits among peer trials
108 1664th of 2000 higher than 335 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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