This is a Phase 2b, investigator- and participant-blinded, placebo-controlled, parallel-arm study to evaluate the efficacy, safety and tolerability of SAB 142 in patients with Stage 3 New Onset of Type 1 Diabetes (NOT1D).
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 15-40 years old at the time of randomisation in Part A. Males and females 5-40 years old*, inclusive, at the time of randomisation in Part B.
Weight ≥16.0 kg at time of randomisation. Participants age 18-40 will have a body mass index (BMI) from 16 to 32 (inclusive).
Participant has received a diagnosis of T1D according to American Diabetes Association criteria within 100 days of randomization. For participants who were initially misdiagnosed with Type 2 diabetes, time from misdiagnosis with Type 2 diabetes to randomization is 100 days. Note: Unless previously diagnosed with preclinical (Stage 1 or Stage 2 T1D), participant must have initiated insulin therapy by the time of randomisation. An extension of no more than 14 days is permitted if a participant has planned and/or is required to receive a vaccination within 30 days prior to randomisation or is completing the 10 day CGM period.
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 (Parts A and B) or 28 days prior to Day 1, TP3 (Part C)
Participant has received teplizumab or any investigational immunomodulatory anti-CD3 treatment within any timeframe prior to screening.
Parallel
High Dose SAB-142
DrugHigh Dose SAB-142
Low Dose SAB-142
DrugLow Dose SAB-142
Placebo
Other interventionPlacebo
Part A: Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
Part B: 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 \[AUC+1\] at 12 months)
Part C: 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 \[AUC+1\] at 24 months versus control).
Time in tight range (TITR)
Expressed as a daily average of the percentage of time in a 24hour day a participant's glucose is \>70 but ≤140 mg/dL (\>3.9 to ≤7.8 mmol/L), assessed using continuous glucose monitoring (CGM)
Haemoglobin A1c (HbA1c) levels
Expressed in % and mmol/mol
Time in range (TIR)
Expressed as a daily average of the percentage of time in a 24-hour day a participant's CGM reading is \>70 but ≤180 mg/dL (\>3.9 to ≤10.0 mmol/L), assessed by CGM
Time above range, assessed by CGM
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