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 (NCT07670650)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of SAB-142 for Delaying the Progression of Type 1 Diabetes (T1D) in Patients With Stage 3 New Onset T1D, Recent Onset T1D, and Established T1D
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of California San Francisco Benioff Children's Hospital — San Francisco, California
Age range: 5 Years to 40 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- University of California San Francisco Benioff Children's Hospital — San Francisco, California
- Barbara Davis Center for Diabetes — Aurora, Colorado
- University of Florida — Gainesville, Florida
- IUH - Riley Hospital for Children - Riley Outpatient Center - Pediatric Diabetes & Endocrinology — Indianapolis, Indiana
📞 Contact the Study Coordinator
Phone: (352) 273-9264
Email: hallemj@peds.ufl.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Type 1 Diabetes (T1D)
- Technology Knowledge Optimization for Type 1 Diabetes in Schools — Pittsburgh, Pennsylvania
- Feasibility Study of a Continuous Glucose-Ketone Monitoring Device in People With Type 1 Diabetes — Palo Alto, California
- Pilot of Food Is Medicine Interventions to Reduce Cardiovascular Disease Risk in Children With Food Insecurity and Diabetes — Providence, Rhode Island
- App-Based Certified Diabetes Education Therapy (AB-CDE) — La Jolla, California
- CKM For Safe Use of SGLT2i in Type 1 Diabetes — La Jolla, California
Explore by condition: All Type 1 Diabetes (T1D) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.