SAFEGUARD (SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes) Study
Recruiting until: 31st Dec 2026
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).
Recruiting sites:
- Barts Health NHS Trust – The Royal London Hospital
Sites opening soon:
- University College London Hospitals NHS Foundation Trust – University College Hospital
- Nottingham University Hospitals NHS Trust – Queen’s Medical Centre (QMC)
- NHS Lothian – Royal Hospital for Sick Children
- Barts Health NHS Trust – The Royal London Hospital
- Noah’s Ark Children’s Hospital for Wales
- Oxford University Hospitals NHS Trust – John Radcliffe Hospital
- Cambridge University Hospitals NHS Foundation Trust – Addenbrookes Hospital
- Alder Hey Children’s NHS Foundation Trust
Summary
Trial of a new medication in people aged 5-40 diagnosed with type 1 diabetes within 100 days of randomization.
Aim
The study aims to check if SAB-142 can stop immune cells from mistakenly attacking insulin-producing cells in the pancreas.
Eligibility to take part
- Age 5-40 years
- Received a diagnosis with type 1 diabetes within 100 days of randomization
If you are interested in taking part, please click the “Get Involved” button below:
What will I be asked to do?
Participants will receive either SAB-142 or placebo through IV infusions over two 2-day periods, six months apart. They will attend regular study visits over 15 months for blood tests, physical exams, and questionnaires. Participants will wear a continuous glucose monitor periodically and will keep a diary of insulin use and low/high blood sugar events. They will continue their usual diabetes care throughout the study.
Who is running this study?
This study is being run by SAB Biotherapeutics Inc.
