A Phase 2b, Randomised, Double-Blind, Placebo-Controlled, Parallel-Arm Dose Finding Study Evaluating the Efficacy and Safety of SAB-142 for Delaying the Progression of Type 1 Diabetes (T1D) in Patients With Stage 3 New Onset of Type 1 Diabetes (NOT1D)
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 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.
• 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.
• 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: The date of diagnosis is defined as the date of the first insulin dose or any other glucose lowering medication. 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 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:
• a. 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 b. 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 signing the consent form until the end of 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 from 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 signing the consent form until 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 from signing the consent form until EOS.
‣ If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, agree to use a condom from signing the consent form until EOS.
⁃ Prior to receiving study drug, participant must agree to receive locally, regionally and/or country-specific required age-appropriate immunisations. Participants are advised but not required to comply with the guidelines for immunosuppressed individuals and those with chronic disease (diabetes mellitus) according to current local, regional and/or country- specific guidelines. Note: Vaccines are permitted within the timeframes specified in exclusion criterion #17.
⁃ 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.
⁃ Participant has suitable venous access for blood sampling.
⁃ Participant is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.