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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 is a Phase 3 study that has not yet begun recruiting, run by University of Florida. The registered enrollment target is 108 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07670650
The ClinicalTrials.gov registry entry for NCT07670650 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07670650 reports 0 study locations.
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.
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