NCT05757713ACTIVE_NOT_RECRUITINGanonymous

Single Arm, Open-label Study to Assess the Safety and Pharmacokinetics of a 14-day Regimen of Teplizumab in Pediatric Stage 2 Type 1 Diabetes (Participants <8 Years of Age With at Least Two Autoantibodies and Dysglycemia)

Sponsor

Source record

Sanofi

Phase

Source record

Phase 4

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Type 1 Diabetes (Stage 2)

Indication / condition

AI-normalized

Diabetes Mellitus, Type 1

Intervention

Source record

teplizumab

Source & freshness

Source record

NCT ID

NCT05757713

Original source

ClinicalTrials.gov

Source last updated

Jan 30, 2026

Ingested at

May 31, 2026

Internal sync

Jun 05, 2026

Model version

trialsignal-ai-v1

Normalized confidence

88%

Validation status

validated

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View original source fields

NCT ID

NCT05757713

Title

Single Arm, Open-label Study to Assess the Safety and Pharmacokinetics of a 14-day Regimen of Teplizumab in Pediatric Stage 2 Type 1 Diabetes (Participants <8 Years of Age With at Least Two Autoantibodies and Dysglycemia)

Sponsor

Sanofi

Status

ACTIVE_NOT_RECRUITING

Phase

Phase 4

Condition raw

Diabetes Mellitus, Type 1

Condition normalized

Diabetes Mellitus, Type 1

Modality raw

Diabetes Mellitus, Type 1

Modality normalized

monoclonal antibody

Target raw

Type 1 Diabetes (Stage 2)

Target normalized

Type 1 Diabetes (Stage 2)

Interventions

teplizumab

Public preview

Source record

Sanofi is conducting a single-arm, open-label clinical trial to evaluate the safety and pharmacokinetics of teplizumab in pediatric patients under 8 years of age with Stage 2 Type 1 Diabetes. The study aims to enroll approximately 20 participants and will assess treatment-emergent adverse events, pharmacokinetics, and immunogenicity over a period of up to 26 months.

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Investment-Ready Snapshot

Single Arm, Open-label Study to Assess the Safety and Pharmacokinetics of a 14-day Regimen of Teplizumab in Pediatric Stage 2 Type 1 Diabetes (Participants <8 Years of Age With at Least Two Autoantibodies and Dysglycemia)

Source & freshness

Public preview

Create an account to unlock this report

Single Arm, Open-label Study to Assess the Safety and Pharmacokinetics of a 14-day Regimen of Teplizumab in Pediatric Stage 2 Type 1 Diabetes (Participants <8 Years of Age With at Least Two Autoantibodies and Dysglycemia)

Investment-Ready Snapshot

Provenance

Protocol Description

Outcome Measures

Eligibility

Known Results And Readout Context

Patent And IP Landscape

Contacts