A Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients
Phase 2
Active, not recruiting
- Conditions
- Diabetes Mellitus, Type 1
- Registration Number
- NCT06025110
- Lead Sponsor
- ITB-Med LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 96
Inclusion Criteria
Inclusion Criteria:<br><br> - Able to understand the study requirements and provide written informed consent<br> before any study assessment is performed<br><br> - Male or female patients = 18 to 45 years of age<br><br> - A diagnosis of type 1 diabetes<br><br>Exclusion Criteria:<br><br> - Women who are pregnant, lactating, or planning on pregnancy during the study<br><br> - History of cancer<br><br> - History of heart disease<br><br> - Recent infection
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in beta-cell function as compared to placebo at week 52.
- Secondary Outcome Measures
Name Time Method Assess the incidence and severity of adverse