Teplizumab in Pediatric Stage 2 Type 1 Diabetes
Purpose
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.
Condition
- Diabetes Mellitus, Type 1
Eligibility
- Eligible Ages
- Between 0 Years and 7 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participant is a male or female 0 to < 8 years of age, inclusive, at Day 1 2. Participant has Stage 2 T1D (two T1D-related autoantibodies and dysglycemia)
Exclusion Criteria
- Participant has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease 2. Has an active infection and/or fever 3. 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). 4. Has any condition that, in the opinion of the Investigator, would interfere with the study conduct or the safety of the participant.
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Single arm, non-randomized, open-label, multi-center study
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental teplizumab injection |
teplizumab injection, sterile solution for intravenous use |
|
Recruiting Locations
Nashville, Tennessee 37232
Clinical and Translational Medicine Lead
More Details
- Status
- Recruiting
- Sponsor
- Provention Bio, a Sanofi Company
Study Contact
Trial Transparency email recommended (Toll free for US & Canada)800-633-1610
Contact-us@sanofi.com
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.