Teplizumab in Pediatric Stage 2 Type 1 Diabetes
- Registration Number
- NCT05757713
- Lead Sponsor
- Provention Bio, a Sanofi Company
- Brief Summary
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.
- Detailed Description
This is a single-arm, non-randomized, open-label, multicenter study in the U.S. to assess the safety and pharmacokinetics of teplizumab in pediatric participants with Stage 2 type 1 diabetes (T1D) (two T1D-related autoantibodies and dysglycemia) who are 0 to \<8 years of age. Anti-drug antibodies/neutralizing antibodies (ADA/NAb) will also be assessed.
Approximately 20 participants will be enrolled. The regimen consists of an intravenous infusion of teplizumab once daily for 14 consecutive days. The study duration for each individual may last up to approximately 26 months.
The safety, tolerability, PK, ADA, and T1D clinical feature data will be summarized using descriptive statistics.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description teplizumab injection teplizumab teplizumab injection, sterile solution for intravenous use
- Primary Outcome Measures
Name Time Method Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), TEAEs leading to withdrawal, and serious adverse events (SAEs) Through 104 Weeks Safety and tolerability endpoint
- Secondary Outcome Measures
Name Time Method Anti-drug antibody (ADA) titers and presence of neutralizing antibodies (Nab) Through 104 weeks Immunogenicity endpoint
Serum concentrations of teplizumab Sparse PK samples between Days 1 and 28 Pharmacokinetic (PK) endpoint
CD3 receptor occupancy Days 1 and 9 To assess the effects of teplizumab on cluster of differentiation 3 (CD3) receptor occupancy
Trial Locations
- Locations (10)
UCSF Medical Center Site Number : 107
🇺🇸San Francisco, California, United States
Barbara Davis Center for Diabetes Site Number : 102
🇺🇸Aurora, Colorado, United States
Yale University School of Medicine Site Number : 101
🇺🇸New Haven, Connecticut, United States
Centricity Research Site Number : 104
🇺🇸Columbus, Georgia, United States
Indianapolis University Health Riley Hospital for Children Site Number : 110
🇺🇸Indianapolis, Indiana, United States
UBMD Pediactrics Site Number : 105
🇺🇸Buffalo, New York, United States
Children's Hospital of Philadelphia Site Number : 108
🇺🇸Philadelphia, Pennsylvania, United States
Sanford Diabetes and Thyroid Clinic Site Number : 106
🇺🇸Sioux Falls, South Dakota, United States
Vanderbilt Univerity Medical Center Site Number : 109
🇺🇸Nashville, Tennessee, United States
MulitCare Institute for Research & Innovation Site Number : 103
🇺🇸Tacoma, Washington, United States