Siplizumab in T1DM (NCT05574335) | Clinical Trial Compass
TerminatedPhase 1/2
Siplizumab in T1DM
Stopped: Prior to termination the DESIGNATE study was an on enrollment hold due to greater than anticipated lymphodepletion. The pharmaceutical partner decided not to reopen its own T1D trial and ceased development of siplizumab in autoimmunity.
United States8 participantsStarted 2023-04-26
Plain-language 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. 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.
Who can participate
Age range8 Years – 45 Years
SexALL
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Inclusion criteria
✓. Ability to provide informed consent (parental permission and informed assent of minor, if applicable).
✓. Male or female between 8 to 45 years of age.
✓. Diagnosis of T1DM within 18 months (550 days) of enrollment (V0).
✓. Positive for at least one diabetes-related autoantibody, including:
✓. Glutamate decarboxylase (GAD-65),
✓. Insulin, if obtained within 10 days of the onset of exogenous insulin therapy,
✓. Insulinoma antigen-2 (IA-2), or
✓. Zinc transporter-8 (ZnT8).
Exclusion criteria
✕. 1\. Use of investigational drugs within 24 weeks of participation with the exception of any vaccine for the prevention of SARS-CoV-2 infection and emergency use authorization medications for treating SARS-CoV-2.
✕
What they're measuring
1
Number of Participants with a T cell phenotype signature response
Timeframe: From week 0 (baseline) to week 12
Trial details
NCT IDNCT05574335
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)