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 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: IRB2026004272025-524787-37-00U1111-1332-1701
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Type 1 Diabetes (T1D)

Outcome Measures

Primary Outcomes (1)

• Area under the concentration-time curve (AUC) of C-peptide after a 2 hour mixed meal tolerance test (MMTT)

  This is a measure of endogenous insulin production and β cell function (change from baseline in C-peptide ln \[AUC+1\].

  Dose administration to 12 Months

Secondary Outcomes (16)

• AUC of C-peptide after a 2-hour MMTT in a priori in vitro identified "responders" and "non-responders"

  Baseline, Months 3, 6, 9 and 12

• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0

  Dose administration to 12 Months

• To evaluate the pharmacokinetics (PK) of SAB-142

  Days 1 and 2 of each treatment period (pre- and post-dose/end of infusion [EOI]), plus Week 1 for TP1 (for participants that attend the optional in-clinic visit), Week 4, and Months 3, and 7.

• To evaluate the immunogenicity of SAB-142

  Baseline, Week 1 (for participants that attend the optional in-clinic visit), Week 4, Months 3, 6, 7, 9, and 12.

• Immunophenotyping following SAB-142 administration will be performed on PBMC using flowcytometry

  Baseline (Day 1, pre-dose), Week 4, Months 3, 6, 7, 9 and 12.

Other Outcomes (26)

• C-peptide quantitative response (QR) metric

  Baseline, Months 3, 6, and 12.

• 2-hour MMTT C-peptide AUC

  Baseline, Months 3, 6, and 12.

• Fasting C-peptide

  Baseline, Months 3, 6, 9, and 12.

Study Arms (2)

SAB-142

EXPERIMENTAL

SAB-142 in recent and established onset T1D

Drug: SAB-142

Placebo

PLACEBO COMPARATOR

Placebo Comparator

Drug: Placebo

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

SAB-142

Placebo DRUG

Placebo Comparator: Placebo

Placebo

Eligibility Criteria

• Age: 5 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participant and/or appropriate legal guardian for participants below the legal age of consent must have given written informed consent and/or assent according to local, regional and/or country specific guidance before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. Participants and legal guardians must be capable of providing informed consent and not be incapacitated.
• Males and females 5-40 years old\*, inclusive, at the time of randomisation.
• \* Note: Age step-down rules apply, as described in protocol Section 6.1.
• Weight ≥16.0 kg at time of randomisation. Participants age 18-40 will have a body mass index (BMI) between 16 to 32 (inclusive).
• Participant has received a diagnosis of T1D according to American Diabetes Association criteria (refer Section 22.1) as following:
• 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.
• Note: Unless previously diagnosed with preclinical (Stage 1 or Stage 2 T1D), participant must have initiated insulin therapy the time of randomisation.
• Participant has random C-peptide levels of \>0.2 nmol/L, measured during Screening. One random C-peptide retest during screening period is allowed.
• Participant completed all scheduled samples for C-peptide collected during the MMTT test during Screening.
• Participant has a positive result on testing for at least one of the following T1D-related autoantibodies during screening:
• 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)

You may not qualify if:

• Participant has known allergy, hypersensitivity or moderate to severe allergic reaction including anaphylaxis to natural or recombinant antibodies, biologic treatments, passive vaccines, pork, or any other component of the study drug formulation (including biologic medications). This includes participants with Hereditary Fructose Intolerance.
• Participant has a known allergy or hypersensitivity to any of the protocol-required concomitant medications.
• Participant has been an active participant in a therapeutic drug, invasive medical device, or vaccine clinical trial within 12 weeks before Screening Visit (SV)2.
• Participant has received teplizumab or any investigational immunomodulatory anti-CD3 treatment within any timeframe prior to screening.
• Participant has a significant uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, neurologic, haematologic, rheumatologic, oncologic, psychiatric, or immune deficiency that may interfere with the participant's safely participating in the study or with interpretation of the safety and/or efficacy profile of investigational medicinal product (IMP). For any disorders, a participant with a stable, well-controlled condition that is not felt to interfere with study participation may be enrolled.
• Participant has any autoimmune disease other than T1D (e.g., latent autoimmune diabetes in adults, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythaematosis) that is currently managed with systemic immunotherapy, with the exception of clinically stable thyroid or celiac disease.
• Participant is prone to infections, or has chronic, recurrent or opportunistic infectious disease, including but not limited to renal, respiratory or skin infections, Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis.
• Participant has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV)-1 or 2, hepatitis B virus (HBV), or hepatitis C virus (HCV) antibodies.
• Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and/or TB testing. Note: Blood testing (e.g., QuantiFERON® TB Gold test) is strongly preferred; if not available, any local approved TB test is allowed.
• Serious systemic viral, bacterial, or fungal infection (e.g., pneumonia, pyelonephritis), infection requiring hospitalisation or IV anti-infective treatments or significant acute or chronic viral (including history of recurrent or active herpes zoster, acute or active CMV, EBV as determined at screening), bacterial, or fungal infection (e.g., osteomyelitis) 30 days before and during screening. Note: Participants with confirmed active EBV or CMV infection based on polymerase chain reaction (PCR) test can be retested; asymptomatic participants with the most recent PCR-negative (defined as PCR \<1000 copies/mL or its equivalent in plasma or serum based on the site-specific PCR assay) test are eligible for participation. Participants with an active mild infection at Screening may be enrolled once the symptoms have resolved and all I/E are met. Participants who have an active infection and/or fever ≥38.0°C (100.4°F) within the 48 hours prior to dose administration should not be dosed.
• Participant has a diagnosis of significant liver disease or at screening ALT and/or AST \>2× or total bilirubin of \>1.5× of the age- and sex-specific upper limit of normal (ULN) according to the site laboratory and confirmed by repeated tests. Liver function tests can be repeated during screening and if normalised, participant may be eligible for randomisation. Note: Participants with Gilbert's syndrome are allowed to enrol if only total and/or indirect bilirubin are elevated above ULN while ALT, AST, and alkaline phosphatase (ALP) are within the normal laboratory ranges.
• An individual has any of the following haematologic parameters, confirmed by repeat tests, during Screening:
• Lymphocyte count: \<1000/μL
• Neutrophil count: \<1500/μL
• Platelet count: \<100 000 platelets/μL

Sponsors & Collaborators

• University of Florida: lead
• SAb Biotherapeutics, Inc.: collaborator
• Breakthrough T1D: collaborator

Study Sites (4)

University of California San Francisco Benioff Children's Hospital

San Francisco, California, 94158, United States

Location

Barbara Davis Center for Diabetes

Aurora, Colorado, 80045, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

IUH - Riley Hospital for Children - Riley Outpatient Center - Pediatric Diabetes & Endocrinology

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Michael JH Haller, MD

CONTACT

(352) 273-9264; hallemj@peds.ufl.edu

Laura M Jacobsen

CONTACT

(352) 265-7337; lauraj@ufl.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants with recent-onset and established-onset Stage 3 T1D will be randomized in a 2:1 ratio to receive SAB-142 or placebo. Data from an external cohort of participants with new-onset T1D enrolled in the SAB-142-201 SAFEGUARD study will be incorporated into the primary efficacy analysis.

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): September 1, 2030
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

US (4)