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HUMAN POLYCLONAL IMMUNOGLOBULIN G AGAINST THYMOCYTE

Clinical trials are studying HUMAN POLYCLONAL IMMUNOGLOBULIN G AGAINST THYMOCYTE in people with recently diagnosed stage 3 type 1 diabetes. The main goals are to check safety, tolerability, and whether the study treatment can slow loss of insulin-making cells in the pancreas.

Table of Contents

Trial overview

The main trial in the data is the SAFEGUARD study, which stands for SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes. It is studying HUMAN POLYCLONAL IMMUNOGLOBULIN G AGAINST THYMOCYTE in people with type 1 diabetes.[1]

The study is authorised, which means it has been approved to move forward in the listed setting.[1]

Who is being studied

This trial is for people who were recently diagnosed with stage 3 type 1 diabetes.[1]

Stage 3 type 1 diabetes means the disease is already clearly present and diagnosed, and the study focuses on this early period after diagnosis.[1]

Study design and phase

This is an interventional study, which means the researchers are giving a study treatment and then watching what happens.[1]

The trial is in Phase 2, a stage where researchers look more closely at safety and begin to test whether the treatment may help the disease.[1]

The planned enrollment is 190 people.[1]

What researchers are measuring

The primary outcomes include recording and reviewing any health problems or side effects that happen during the study.[1]

Researchers are also checking measures of pancreas function related to insulin production, which helps show whether the pancreas is still making insulin well.[1]

The brief summary says the study wants to learn about safety and tolerability, and also find out whether the treatment can slow the decline of insulin-producing cells in the pancreas over the course of the study.[1]

Treatment regimens in the study

The intervention list includes SAB-142 given by intravenous administration and a sodium chloride infusion used as the comparison treatment.[1]

SAB-142 is named in the trial details as the study drug linked to HUMAN POLYCLONAL IMMUNOGLOBULIN G AGAINST THYMOCYTE.[1]

Why this trial matters

This study is trying to answer an important question: can treatment given soon after diagnosis help protect the pancreas in type 1 diabetes?[1]

By focusing on safety, tolerability, and pancreas function, the trial is designed to show both how people handle the treatment and whether it may help preserve insulin-making cells.[1]

Trial ID Phase Condition studied Status Enrollment
2025-521560-36-00 Phase 2 Type 1 Diabetes Authorised 190

FAQ

  • What condition is being studied with HUMAN POLYCLONAL IMMUNOGLOBULIN G AGAINST THYMOCYTE? The trial is studying type 1 diabetes, especially people who were recently diagnosed with stage 3 type 1 diabetes.
  • Who can take part in the trial? The study is for people recently diagnosed with stage 3 type 1 diabetes. Other detailed entry rules are not provided in the trial data.
  • What is the main goal of the study? The study wants to learn about safety and tolerability, and also see whether the treatment can slow the decline of insulin-producing cells in the pancreas.
  • What phase is this trial? This is a Phase 2 trial. Phase 2 studies look more closely at whether a treatment may work and continue to check safety.
  • How many people are planned for the study? The planned enrollment is 190 people.

Ongoing Clinical Trials on HUMAN POLYCLONAL IMMUNOGLOBULIN G AGAINST THYMOCYTE

  • A Study of SAB-142 to Slow the Progression of Type 1 Diabetes in Adults and Children Recently Diagnosed with the Disease

    Recruiting

    1 1
    Investigated drugs:
    Austria Belgium Denmark Finland France Germany +5

Glossary

  • Type 1 diabetes: A condition where the body does not make enough insulin because the insulin-producing cells in the pancreas are damaged.
  • Stage 3 type 1 diabetes: A later stage of type 1 diabetes when the disease is already clearly present and has been diagnosed.
  • Recently diagnosed: The person was diagnosed not long ago. In this study, that timing matters for who can join.
  • Phase 2: A trial stage that checks safety and starts to look at whether the treatment may help.
  • Interventional study: A study where researchers give a treatment and watch what happens.
  • Safety: Whether the treatment causes health problems or side effects.
  • Tolerability: How well people can handle the study treatment without major problems.
  • Insulin-producing cells: Cells in the pancreas that make insulin, a hormone needed to control blood sugar.
  • Pancreas function: How well the pancreas is working, including how well it makes insulin.
  • Intravenous administration: Giving a treatment through a vein, usually with a needle or drip.

References

  1. https://clinicaltrials.gov/study/2025-521560-36-00