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Clinical Trial Details

Trial ID: L5925
Source ID: NCT06791291
Associated Drug: Teplizumab
Title: Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: Teplizumab
Outcome Measures: Primary: Number of participants with Stage 3 Type 1 Diabetes based on American Diabetes Association criteria, From baseline up to Week 104|Change from baseline in area under the curve (AUC) of C-peptide, From baseline up to Week 104|Change from baseline in endogenous insulin, From baseline up to Week 104|Number of participants with TEAEs, SAEs, AEs leading to permanent study intervention- or study discontinuation; AEs of special interest; number of participants with clinically significant changes in vital signs, ECG, and/or safety laboratory test, TEAE: treatment-emerged adverse event; SAE: serious adverse event; AE: adverse event, Throughout the study, approximately 756 days | Secondary: Change from baseline in fasting plasma glucose (FPG) from an oral glucose tolerance test, From baseline up to Week 104|Change from baseline in 2-hour plasma glucose from an oral glucose tolerance test, From baseline up to Week 104|Change from baseline of hemoglobin A1c (HbA1c), From baseline up to Week 104|Serum concentration of teplizumab, From Day 1 to Day 28|CD3 receptor occupancy, From baseline to Day 28|Number of participants with anti-drug antibodies, From baseline up to Week 104|Number of participants with neutralizing antibodies, From baseline up to Week 104
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE2
Enrollment: 10
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-03-26
Completion Date: 2028-03-06
Results First Posted:
Last Update Posted: 2025-02-18
Locations:
URL: https://clinicaltrials.gov/show/NCT06791291