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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of Florida
Study ID
NCT07670650
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Type 1 Diabetes (T1D)

Eligibility Criteria

Sex
ALL
Age
5 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • SAB-142 — DRUG
    Treatment Period 1 (Induction) Day 1: SAB-142 0.5 mg/kg IV Day 2: SAB-142 2.0 mg/kg IV Treatment Period 2 (Month 6 Maintenance) Day 1: SAB-142 0.5 mg/kg IV Day 2: SAB-142 1.0 mg/kg IV Total induction dose: 2.5 mg/kg Total maintenance dose: 1.5 mg/kg
  • Placebo — DRUG
    Placebo Comparator: Placebo

Study Details

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.

Key Dates

Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Mar 1, 2029
Completion
Sep 1, 2030

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SAB-142
    SAB-142 in recent and established onset T1D
  • Placebo Comparator: Placebo
    Placebo Comparator

Primary Outcome Measure

Area under the concentration-time curve (AUC) of C-peptide after a 2 hour mixed meal tolerance test (MMTT) [ Time Frame: Dose administration to 12 Months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of California San Francisco Benioff Children's HospitalSan FranciscoCalifornia94158
Stephen Gitelman, MD
[email protected]
415-476-3748
Barbara Davis Center for DiabetesAuroraColorado80045-
University of FloridaGainesvilleFlorida32610
Jennifer L Hosford, MPH
[email protected]
352-294-5759
Laura Jacobsen, MD (PRINCIPAL_INVESTIGATOR)
IUH - Riley Hospital for Children - Riley Outpatient Center - Pediatric Diabetes & EndocrinologyIndianapolisIndiana46202
Linda DiMeglio, MD
[email protected]
317-274-7595

Find similar trials in San Francisco, CA

By research site
University of California San Francisco Benioff Children's Hospital· San Francisco, CABarbara Davis Center for Diabetes· Aurora, COUniversity of Florida· Gainesville, FLIUH - Riley Hospital for Children - Riley Outpatient Center - Pediatric Diabetes & Endocrinology· Indianapolis, IN

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