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

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Type 1 Diabetes (T1D)

In brief

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 facts

Study ID

NCT07670650

Run by

University of Florida

People needed

108

Starts

2026-09-01

Expected to finish

2030-09-01

Last updated by the study team

2026-06-26

Who can join

Age: 5 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

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)
• Female participants:
• Must be of nonchildbearing potential, i.e., pre-pubertal*, surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening, or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle -stimulating hormone [FSH] level consistent with postmenopausal status, per local laboratory guidelines), or
• If of childbearing potential, must:
• i.Have a negative result on a serum (beta human chorionic gonadotropin [β-hCG]) at screening and a negative urine β-hCG pregnancy test prior to study drug administration on Day 1 of both treatment periods.
• ii.Agree not to become pregnant or donate ova from the time of signing the consent form until the end of the study visit.
• iii.If not exclusively in a same-sex relationship or abstinent as a committed lifestyle, must agree to use adequate contraception (which is defined as use of a condom by the male partner combined with use of a highly effective method of contraception [Section 11.3.1]) from the time of signing the consent and for the duration of the study.
• Note: Female participants will be considered to be pre-pubertal (and of nonchildbearing potential) if they have not yet started menstruation. This should also be verified by the parent(s)/guardian(s). If a female participant reaches menarche during the study, then she is to be considered as a woman of childbearing potential from that time forwards, and contraceptive requirements will apply.
• Male participants, if not biologically or surgically sterilised, must:
• Agree not to donate sperm from the time of signing the consent form until End of Study (EOS).
• If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception [refer to Section 11.3.1]) from the time of signing the consent form until EOS.

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
• Haemoglobin: <10 g/dL
• Note: Specific haematologic, oncologic or other systemic conditions that might otherwise result in exclusion and/or is heretofore unrecognised should be considered in individuals who have one or more blood cell counts below or above the references ranges.
• Current or prior (within 5× half-lives before SV2) treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, including systemic glucocorticoids, verapamil, baricitinib, and others. Note: Inhaled and topical corticosteroids are allowed. Short courses, i.e., approximately 2 weeks or less, of systemic corticosteroids for transient conditions are allowed.
• Current or prior (within 5× half-lives before SV2) use of drugs other than insulin to treat hyperglycaemia (e.g., metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, glucagon-like peptide 1 agonists [glucagon-like peptide-1], dipeptidyl peptidase-4 [DPP-IV] inhibitors, or amylin).
• Current or prior (within 5× half-lives before SV2) use of any medication known to significantly influence glucose tolerance (e.g., atypical antipsychotics, diphenylhydantoin, niacin).
• Current or planned highly restrictive dietary regimen(s) that would interfere with participant well-being or impact on the investigational drug.
• Recent or planned vaccinations as follows:
• Countries within the EU member states only:
• Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): from 30 days before dosing through 6 months following administration of SAB-142 for each TP;
• Recombinant, inactivated or otherwise "non-live" vaccines: from 30 days before dosing or within 60 days following dosing; or planned/required within 30 days prior to or 60 days following Day 1 of TP2.

Where it is running

• University of California San Francisco Benioff Children's Hospital — San Francisco, California, United States
• Barbara Davis Center for Diabetes — Aurora, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• IUH - Riley Hospital for Children - Riley Outpatient Center - Pediatric Diabetes & Endocrinology — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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