Status:
TERMINATED
A Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients
Lead Sponsor:
ITB-Med LLC
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
The goal of this study is to determine if treatment with TCD601 improves beta-cell function in adults recently diagnosed with type 1 diabetes compared to placebo.
Eligibility Criteria
Inclusion
- Able to understand the study requirements and provide written informed consent before any study assessment is performed
- Male or female patients ≥ 18 to 45 years of age
- A diagnosis of type 1 diabetes
Exclusion
- Women who are pregnant, lactating, or planning on pregnancy during the study
- History of cancer
- History of heart disease
- Recent infection
Key Trial Info
Start Date :
January 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06025110
Start Date
January 23 2023
End Date
July 24 2025
Last Update
August 14 2025
Active Locations (26)
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1
UZ Brussel
Brussels, Belgium, 1090
2
UZ Leuven
Leuven, Belgium, 3000
3
Azienda Ospedaliero-Universitaria Renato Dulbecco
Catanzaro, Italy, 88100
4
San Raffaele Hospital
Milan, Italy, 20132