PRISE (Personalized Response and Immunologic Surveillance of Endogenous C-Peptide Preservation in… (NCT07670650) | Clinical Trial Compass
Not Yet RecruitingPhase 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
United States108 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
5 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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:
. Participant has random C-peptide levels of \>0.2 nmol/L, measured during Screening. One random C-peptide retest during screening period is allowed.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area under the concentration-time curve (AUC) of C-peptide after a 2 hour mixed meal tolerance test (MMTT)
. 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:
. Female participants:
Exclusion criteria
1. Participant agrees not to receive other forms of experimental treatment from the time of signing informed consent and for the duration of the study, particularly agents that may be immune modulatory in nature and/or stimulate pancreatic β cell regeneration or insulin secretion.
2. Participant has suitable venous access for blood sampling.
3. Participant is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
. 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.