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Siplizumab in T1DM
Condition: Type 1 Diabetes Mellitus · Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
About this study
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. If indicated, participants will enter into long-term safety monitoring for up to an additional 48 weeks. Blood samples for mechanistic analyses will be obtained during the treatment phase and thereafter. Adults aged 18- 45 will be enrolled initially at the study sites. The primary objective is to identify a safe, metabolically favorable, dosing regimen for siplizumab in patients with type 1 diabetes that induces changes in T cell phenotypes observed with alefacept therapy in new-onset T1DM. The secondary objectives are to: 1. Assess the safety profile of siplizumab in recently diagnosed T1DM. 2. Assess the effects of siplizumab on residual beta cell function in recently diagnosed T1DM participants.
This description comes directly from the study's public registry record.
Talk to the study team
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Locations (5)
| University of Colorado School of Medicine: Barbara Davis Center for Diabetes | Aurora, Colorado, United States | — |
| University of Iowa Children's Hospital: Department of Pediatrics, Pediatric Endocrinology and Diabetes | Iowa City, Iowa, United States | — |
| Columbia University Medical Center: Naomi Berrie Diabetes Center | New York, New York, United States | — |
| University of Texas Southwestern Medical Center: Department of Internal Medicine, Division of Endocrinology | Dallas, Texas, United States | — |
| Benaroya Research Institute at Virginia Mason: Diabetes Research Program | Seattle, Washington, United States | — |
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Source record: clinicaltrials.gov/study/NCT05574335