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Siplizumab

Clinical trials are investigating Siplizumab in people with new onset type 1 diabetes and in transplant recipients. These studies are looking at safety, immune effects, and whether Siplizumab can help protect transplanted organs or preserve pancreas function after diagnosis.

Table of Contents

Clinical trial overview

The source data include three Phase 2 clinical trials of Siplizumab.[1][2][3] All three were interventional studies, which means researchers assigned a treatment and then measured what happened.[1][2][3] The trials studied different patient groups: people with new onset type 1 diabetes, kidney transplant recipients, and liver transplant recipients.[1][2][3]

New onset type 1 diabetes study

The STRIDE study was a 12-month, randomized, single-blind, placebo-controlled exposure-response study in adults with new onset type 1 diabetes.[1] It enrolled 143 people and was completed.[1] The study tested whether 12 weeks of Siplizumab could help preserve beta-cell function, which is the ability of the pancreas to make insulin.[1]

The main endpoint was the change from baseline in mean 4-hour stimulated C-peptide AUC after a MMTT at week 52 compared with placebo.[1] In simple terms, the trial measured how much insulin-making activity remained after treatment.[1] The study also included comparison treatments listed in the source data, including placebo-related and supportive study medicines.[1]

Kidney transplant study

Another Phase 2 trial studied Siplizumab in de novo renal transplant recipients, meaning people who had recently received a kidney transplant.[2] This study was completed and enrolled 46 participants.[2] It compared Siplizumab with rabbit anti-thymocyte globulin, also called rATG, and followed patients for 12 months after transplant.[2]

The goal was to assess safety, tolerability, pharmacokinetics, and pharmacodynamics.[2] Pharmacokinetics means how the body handles a treatment over time, and pharmacodynamics means what the treatment does in the body.[2] The trial also measured immune markers, CD2 receptor occupancy, estimated glomerular filtration rate (eGFR), and anti-siplizumab antibodies.[2]

Liver transplant study

A third Phase 2 study looked at whether a Siplizumab-based regimen could induce allogeneic tolerance in deceased donor liver transplant recipients.[3] This study was suspended and planned to enroll 12 participants.[3] The condition studied was prevention of liver allograft rejection following tolerance induction.[3]

The main outcome was the proportion of patients who were free from immunosuppression at month 30 after transplant.[3] In patient-friendly terms, the study asked whether some people could keep the new liver working without long-term rejection medicine.[3]

Main outcomes measured

The diabetes study focused on a biological marker of pancreas function, especially stimulated C-peptide after a meal test.[1] The kidney transplant study focused on safety, lab results, immune effects, kidney function, and antibodies against the study drug.[2] The liver transplant study focused on whether patients could remain free from immunosuppression after transplant.[3]

  • Safety outcomes included adverse events, serious adverse events, and changes in lab tests and vital signs in the kidney transplant study.[2]

  • Immune outcomes included immunophenotyping, CD2 receptor occupancy, and anti-siplizumab antibodies in the kidney transplant study.[2]

  • Function outcomes included C-peptide in type 1 diabetes and eGFR in kidney transplant recipients.[1][2]

Who the studies included

The trials focused on specific patient groups rather than the general public.[1][2][3] One study included adults with recently diagnosed type 1 diabetes.[1] Another included people who had just received a kidney transplant.[2] The third included deceased donor liver transplant recipients.[3]

The source data do not provide the full enrollment rules for each trial, so the exact medical and laboratory requirements are not listed here.[1][2][3] What is clear is that each trial targeted a different clinical setting where the immune system plays an important role.[1][2][3]

Trial ID Phase Condition studied Status Enrollment
NCT06025110 Phase 2 New onset type 1 diabetes Completed 143
2023-507895-36-00 Phase 2 Renal transplantation Completed 46
2023-508397-29-00 Phase 2 Prophylaxis against liver allograft rejection following tolerance induction Suspended 12

FAQ

  • What conditions have been studied with Siplizumab? The trials in the source data studied new onset type 1 diabetes, kidney transplant, and liver transplant. Each study looked at a different goal, such as preserving beta-cell function or preventing organ rejection.
  • Who could take part in these trials? The studies included adults with newly diagnosed type 1 diabetes, de novo kidney transplant recipients, and deceased donor liver transplant recipients. The exact entry rules are not fully listed in the source data.
  • What phase were the Siplizumab trials? All three trials were Phase 2 studies. Phase 2 trials usually look more closely at safety and early signs that a treatment may work.
  • What were the main goals of the trials? One trial studied beta-cell function in type 1 diabetes, one studied safety and immune effects after kidney transplant, and one studied whether a siplizumab-based plan could help patients stop immunosuppression after liver transplant.
  • Were the trials completed? Two trials were completed and one trial was suspended. The completed studies were in type 1 diabetes and kidney transplant, while the liver transplant study was stopped before completion.

Ongoing Clinical Trials on Siplizumab

  • Study on Siplizumab, Cyclophosphamide, and Splenectomy for Preventing Liver Transplant Rejection in Patients Receiving a Deceased Donor Liver

    Not yet recruiting

    2 1 1
    Investigated drugs:
    Sweden

  • Study on Siplizumab and Rabbit Anti-Thymocyte Globulin for Preventing Rejection in New Kidney Transplant Patients

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Austria Spain Sweden

  • Study on the Effects of Siplizumab in Adults with New Onset Type 1 Diabetes

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Italy Spain Sweden

Glossary

  • Phase 2: A study stage that checks early signs of benefit and continues to watch safety in a smaller group of people.
  • Interventional study: A trial where researchers give a treatment or compare treatments to see what happens.
  • Randomized: People are placed into study groups by chance, which helps make the comparison fair.
  • Single-blind: A study design where one side, usually the participant, does not know which treatment is given.
  • Placebo: An inactive treatment used for comparison so researchers can see whether the study drug makes a difference.
  • Beta-cell function: How well the insulin-making cells in the pancreas are working.
  • C-peptide: A marker in the blood that helps show how much insulin the body is making.
  • MMTT: Mixed-meal tolerance test, a test used to measure how the body responds after eating and to check insulin production.
  • Kidney transplant recipient: A person who has received a new kidney.
  • Liver transplant recipient: A person who has received a new liver.
  • Allograft rejection: When the immune system attacks a transplanted organ.
  • Immunosuppression: Treatment that lowers the immune system to help prevent rejection of a transplanted organ.

References

  1. https://clinicaltrials.eu/trial/study-on-the-effects-of-siplizumab-in-adults-with-new-onset-type-1-diabetes/
  2. https://clinicaltrials.gov/study/2023-507895-36-00
  3. https://clinicaltrials.gov/study/2023-508397-29-00