STRIDE
Research type
Research Study
Full title
A 12-month, randomized, single-blind, placebo-controlled exposure-response study of TCD601 (siplizumab) in new onset type 1 diabetes patients (STRIDE)
IRAS ID
1008161
Contact name
Alan Slade
Contact email
Sponsor organisation
ITB-Med AB
Eudract number
2022-001713-39
Research summary
Type 1 Diabetes (T1D) is an autoimmune disease, which means that the immune system is mistakenly attacking an individual’s own cells. The cells in the pancreas (the organ that makes insulin) are the target of this attack. When too many of these cells are lost, individuals cannot make enough insulin to control the amount of sugar in their blood.
This study is sponsored by ITB-MED and will take place at up to 10 sites in the UK. The purpose of this study is to find out if the effect of siplizumab treatment (an investigational medication), compared to placebo (an identical-looking medication that does not contain active study drug), will help stabilize T1D and maintain or reduce the amount of daily insulin patients need to inject.
Participants, who have been diagnosed with T1D within 100 days may be eligible for participation in this research. We expect that taking part in this research will last around 12 to 15 months. During this time there are 18 planned study visits with the study doctor and team. Participants will be randomly assigned to one of the two treatment groups (study drug at one of 3 dose levels or placebo) and will visit the research site for treatment visits every week for 12 weeks and then visit the research site for follow-up visits every three months until the end of the study at Month 12.
In addition to study medication (siplizumab or placebo), all participants will receive routine medical care and treatments for their T1D, such as continuous glucose monitoring, daily insulin, laboratory tests, as well as dietary and lifestyle modifications as prescribed by the study doctor . Additional research or study-specific assessments or procedures, such as blood draws and completion of a daily electronic diary will also occur. After completion of the study, participants will continue to receive routine care by their regular doctor.REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0670
Date of REC Opinion
29 Aug 2023
REC opinion
Further Information Favourable Opinion