Clinical Trial: Siplizumab in T1DM
Study Status: Completed
Recruit Status: RECRUITING
Condition: Type 1 Diabetes Mellitus
Study Type: INTERVENTIONAL
Official Title: A T Cell Phenotype Signature Driven Dose Finding Study With Siplizumab in Type 1 Diabetes Mellitus (ITN095AI)
Brief Summary:
This is a multicenter, Phase Ib, open-label, siplizumab dose-finding study in individuals aged 8-45 years with a Type 1 diabetes mellitus (T1DM) diagnosis.within 18 months of V0.Participants will be randomized 1:1:1:1 to one of four possible siplizumab dosing arms.All dosing arms will receive weekly siplizumab doses for a total of 12 weeks.After the completion of treatment, participants will undergo follow-up visits at weeks 12, 24, 36 and 52 which include longitudinal MMTTs.Blood samples for mechanistic analyses…
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