NCT05757713CompletedPhase 4
Teplizumab in Pediatric Stage 2 Type 1 Diabetes
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: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
The purpose of this study is to assess the safety and pharmacokinetics (PK) of teplizumab in participants with Stage 2 type 1 diabetes who are \<8 years of age.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 13 Feb 2023
- Start date
- 25 Jul 2023
- Primary completion date
- 28 Aug 2026
- Lead sponsor
- Sanofi
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT05757713
- EudraCT number
- 2024-000581-19
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 23
- From 25 Jul 2023 to the primary completion date, 28 Aug 2026
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participant has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease
- Has an active infection and/or fever
- Has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
- Has any condition that, in the opinion of the Investigator, would interfere with the study conduct or the safety of the participant.
Who the study is looking for
- Participant is a male or female 0 to \< 8 years of age, inclusive, at Day 1
- Participant has Stage 2 T1D (two T1D-related autoantibodies and dysglycemia)
Age in the registry: 0 years to 7 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Barbara Davis Center for Diabetes Site Number : 102 Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Indianapolis University Health Riley Hospital for Children Site Number : 110 Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Vanderbilt Univerity Medical Center Site Number : 109 Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Yale University School of Medicine Site Number : 101 Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Children's Hospital of Philadelphia Site Number : 108 Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| UCSF Medical Center Site Number : 107 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Sanford Diabetes and Thyroid Clinic Site Number : 106 Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| MulitCare Institute for Research & Innovation Site Number : 103 Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
Related publications
- Safety and pharmacokinetics of teplizumab in children less than 8 years of age with stage 2 type 1 diabetes.Diabetologia · 2026 · PMID 41196293
This page is information, not medical advice. Discuss any trial with your doctor.