Designate - Siplizumab in T1DM

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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.

Who Do I Contact?

If you are interested in participating in the study or want to learn more please contact our study team at T1DMresearch [at] chop.edu or 215-590-5007.

Eligibility & Criteria

IRB #:
22-020660
Official Title:
A T cell phenotype signature driven dose finding study with siplizumab in type 1 diabetes mellitus (ITN095AI)
Study Phase:
Phase I
Eligible Age Range:
18 - 45 Years
Gender:
All
Study Categories:

Visit Criteria

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.

Leader
Steven M. Willi, MD

Steven M. Willi, MD