In short
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.
Key points
- Siplizumab has been studied in three Phase 2 clinical trials. One trial looked at adults with new onset type 1 diabetes and measured beta-cell function after treatment. Another trial studied de novo kidney transplant recipients and focused on safety, immune effects, and kidney function. A third trial studied deceased donor liver transplant recipients and asked whether a siplizumab-based regimen could help patients become free from immunosuppression. Two trials were completed, and one liver transplant study was suspended.
Clinical trial overview
The source data include three Phase 2 clinical trials of Siplizumab. All three were interventional studies, which means researchers assigned a treatment and then measured what happened. The trials studied different patient groups: people with new onset type 1 diabetes, kidney transplant recipients, and liver transplant recipients.
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. It enrolled 143 people and was completed. The study tested whether 12 weeks of Siplizumab could help preserve beta-cell function, which is the ability of the pancreas to make insulin.
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. In simple terms, the trial measured how much insulin-making activity remained after treatment. The study also included comparison treatments listed in the source data, including placebo-related and supportive study medicines.
Kidney transplant study
Another Phase 2 trial studied Siplizumab in de novo renal transplant recipients, meaning people who had recently received a kidney transplant. This study was completed and enrolled 46 participants. It compared Siplizumab with rabbit anti-thymocyte globulin, also called rATG, and followed patients for 12 months after transplant.
The goal was to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. Pharmacokinetics means how the body handles a treatment over time, and pharmacodynamics means what the treatment does in the body. The trial also measured immune markers, CD2 receptor occupancy, estimated glomerular filtration rate (eGFR), and anti-siplizumab antibodies.
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. This study was suspended and planned to enroll 12 participants. The condition studied was prevention of liver allograft rejection following tolerance induction.
The main outcome was the proportion of patients who were free from immunosuppression at month 30 after transplant. In patient-friendly terms, the study asked whether some people could keep the new liver working without long-term rejection medicine.
Main outcomes measured
The diabetes study focused on a biological marker of pancreas function, especially stimulated C-peptide after a meal test. The kidney transplant study focused on safety, lab results, immune effects, kidney function, and antibodies against the study drug. The liver transplant study focused on whether patients could remain free from immunosuppression after transplant.
- Safety outcomes included adverse events, serious adverse events, and changes in lab tests and vital signs in the kidney transplant study.
- Immune outcomes included immunophenotyping, CD2 receptor occupancy, and anti-siplizumab antibodies in the kidney transplant study.
- Function outcomes included C-peptide in type 1 diabetes and eGFR in kidney transplant recipients.
Who the studies included
The trials focused on specific patient groups rather than the general public. One study included adults with recently diagnosed type 1 diabetes. Another included people who had just received a kidney transplant. The third included deceased donor liver transplant recipients.
The source data do not provide the full enrollment rules for each trial, so the exact medical and laboratory requirements are not listed here. What is clear is that each trial targeted a different clinical setting where the immune system plays an important role.