Designate - Siplizumab in T1DM

Designate - Siplizumab in T1DM

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Description
The goal of this study is to identify a safe dosing regimen for siplizumab in participants with type 1 diabetes. Siplizumab is a drug used to help treat recent onset type 1 diabetes mellitus (T1DM). This study is interested in participants aged 18-45 years with T1DM, who are within 18 months of receiving their diagnosis. Participants will be randomized (selected at random by the study team) to one of four possible treatment groups. All groups will receive weekly siplizumab doses administered subcutaneously (injected into the body through the skin) for a total of 12 weeks.

Eligibility and criteria
IRB Number:
22-020660
Eligible age range:
18 years - 45 years
Clinical trial phase:
Phase I
Official title:
A T cell phenotype signature driven dose finding study with siplizumab in type 1 diabetes mellitus (ITN095AI)

What to expect
After the completion of siplizumab treatment, participants will undergo follow-up visits at weeks 12, 24, 36 and 52, which include longitudinal mixed meal tolerance tests (MMTTs) as an assessment. Blood samples will also be obtained during the study visits. Participants will be compensated for their time.

Related specialties
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