Disclaimer

The elements presented on this page are not an exhaustive list of information relating to the clinical trial. The inclusion and exclusion criteria have been simplified and should be interpreted by a physician. For more information please visit CTIS website for Safeguard.

Study design 

  • Study Type: Interventional  (Clinical Trial)
  • Estimated Enrollment: 159 participants
  • Allocation: Randomized (with approximately 33% [1:3] probability of receiving placebo).
  • Purpose: The purpose of this study is to evaluate the efficacy and safety of 2 dose levels of SAB-142 through the full duration of the study. 
  • Official Title: 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).
  • Duration of Participation: Participants will undergo two 2‑days treatment periods, administered 6 months apart. The total study duration will be approximately up to 15 months.

Criteria

Recruitment for this study is only open to people who meet these criteria.

Highlighted Inclusion:

  • Age: 12-40 years old
  • Weight ≥16.0 kg at time of randomization. Participants age 18-40 will have a BMI between 16 to 32 (inclusive).
  • Participants diagnosed with T1D Stage 3 according to American Diabetes Association criteria within 100 days of randomization.
  • Participants must be positive for at least one T1D autoantibody at screening:
    • Glutamic acid decarboxylase (GAD-65) 
    • Insulinoma Antigen-2 (IA-2) 
    • Zinc-transporter 8 (ZnT8) or 
    • Insulin autoantibodies (if testing within the first 14 days of insulin treatment).
  • Participants must be up to date with vaccines required by local or national health authorities.
  • If female, participants must meet conditions that prevent pregnancy during the study (for example, not having started menstruation, being post‑menopausal, having had certain surgeries, or using reliable birth control).

Highlight Exclusion: 

  • Participants cannot have a known allergy or severe reaction to similar medicines or any ingredient in the study treatment.
  • Participant cannot have received teplizumab or any investigational immunomodulatory anti-CD3 treatment within any timeframe prior to screening.
  • Participants cannot have taken part in another clinical trial within a set period before joining this study
  • Participants cannot have another autoimmune disease that requires immune system affecting treatment (except stable thyroid or celiac disease).
  • Participants cannot have serious health problems affecting the heart, liver, kidneys, or immune system, or have uncontrolled diabetes complications.
  • Participants cannot have certain infections such as HIV, hepatitis B, or hepatitis C.

Outcome measures

Area under the concentration-time curve (AUC) of C-peptide after a 2hour (2-h) MMTT, a measure of endogenous insulin production and β cell function (change from baseline in C-peptide ln [AUC+1] at 12 months).

Locations

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Participant sites
Please note that this list will be updated regularly

This does not mean that all INNODIA Clinical Trial Sites will participate in this specific study.    
Some additional sites that are not part of the INNODIA Network may run this study too.    
A complete list of participating sites can be found on CTIS website.

Sponsors and Collaborators

SAB Biotherapeutics