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.
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).
For Cohort 2: within >100 days but <1 year (365 days) of randomisation;
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.
Parallel
SAB-142
DrugTreatment 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
DrugPlacebo Comparator: Placebo
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 \[AUC+1\].
AUC of C-peptide after a 2-hour MMTT in a priori in vitro identified "responders" and "non-responders"
This is achange from baseline in C--peptide ln \[AUC+1\] at 12 months) in a priori in vitro identified "responders" and "non-responders" to SAB-142 and compared to placebo.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs).
To evaluate the pharmacokinetics (PK) of SAB-142
Evaluate SAB-142 serum concentrations over the infusion
To evaluate the immunogenicity of SAB-142
Incidence and titres of anti-SAB-142 antibodies in serum including neutralising antibodies (nAbs) if indicated.
C-peptide quantitative response (QR) metric
2-hour MMTT C-peptide AUC
Fasting C-peptide
Proportion of participants maintaining a clinically significant stimulated peak C-peptide of ≥0.2 nmol/L during the 2-hour MMTTs
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