DESIGNATE: A T cell phenotype signature driven dose finding study with siplizumab in type 1 diabetes mellitus
L
Linda DiMeglio, MD
Primary Investigator
Enrolling By Invitation
8-45 years
All
Phase
N/A
120 participants needed
5 Locations
Overview
Researchers are looking for volunteers between 8-45 years of age who have been recently diagnosed with Type 1 diabetes mellitus (T1DM)ke part in a study identify a safe, metabolically favorable,
dosing regimen of a treatment called siplizumab that targets the immune
response and missing beta cell function that leads to T1DM.
Your participation may help researchers to identify therapies that could slowble reverse the autoimmune destruction of beta cells and find safe and effective means to preserve beta cell function in people who have Type 1 diabetes.
Your participation may help researchers to identify therapies that could slowble reverse the autoimmune destruction of beta cells and find safe and effective means to preserve beta cell function in people who have Type 1 diabetes.
Description
What is involved if I participate?
- All participants will receive one dose of Siplizumab weekly for 12 weeks based on the randomization assignment. (dose will be administered by injection by trained medical study staff).
- Body temperature, blood pressure, pulse and respiration will be taken immediately before and after study drug administration.
- Total study participation lasts 52 weeks.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Type 1 diabetes, T1DM, Riley
-
Age: Between 8 Years - 45 Years
-
Gender: All
Inclusion Criteria:
- Diagnosis of Type 1 diabetes mellitus (T1DM) within 18 months (550 days) of enrollment
Exclusion Criteria:
- Past or current medical problems or findings from physical examination or laboratory
testing which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant’s ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
Updated on
13 Sep 2024.
Study ID: 17596, PENDO-NIAID-DESIGNATE, NCT05574335
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