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Teplizumab in Pediatric Stage 2 Type 1 Diabetes (PETITE-T1D)

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
teplizumab
Sponsored by
Provention Bio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Stage 2 T1D, Pediatric T1D

Eligibility Criteria

0 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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.

Sites / Locations

  • Clinical Site 107Recruiting
  • Clinical Site 102Recruiting
  • Clinical Site 101Recruiting
  • Clinical Site 104Recruiting
  • Clinical Site 110Recruiting
  • Clinical Site 105Recruiting
  • Site 109Recruiting
  • Clinical Site 103Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

teplizumab injection

Arm Description

teplizumab injection, sterile solution for intravenous use

Outcomes

Primary Outcome Measures

Frequency of TEAEs, AESIs, TEAEs leading to withdrawal, SAEs
Safety Endpoint
Serum concentrations of teplizumab
Pharmacokinetics endpoint

Secondary Outcome Measures

Serum concentration of ADA anti-drug antibodies (anti-teplizumab antibodies in ng/mL)
Immunogenicity endpoint
Serum concentration of NAb anti-drug antibodies (anti-teplizumab neutralizing antibodies in ng/mL)
Immunogenticity endpoint
Serum concentration of CD3 receptor occupancy on T cells
Pharmacodynamic endpoint

Full Information

First Posted
February 13, 2023
Last Updated
October 23, 2023
Sponsor
Provention Bio, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05757713
Brief Title
Teplizumab in Pediatric Stage 2 Type 1 Diabetes
Acronym
PETITE-T1D
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2023 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Provention Bio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the safety and 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 and serologic response to vaccines and exploratory T1D clinical features will be explored. Approximately 20 participants will be enrolled The regimen consists 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 Diabetes, Stage 2 T1D, Pediatric T1D

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Single arm, non-randomized, open-label, multi-center study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
teplizumab injection
Arm Type
Experimental
Arm Description
teplizumab injection, sterile solution for intravenous use
Intervention Type
Biological
Intervention Name(s)
teplizumab
Intervention Description
CD3-directed humanized monoclonal antibody
Primary Outcome Measure Information:
Title
Frequency of TEAEs, AESIs, TEAEs leading to withdrawal, SAEs
Description
Safety Endpoint
Time Frame
104 Weeks
Title
Serum concentrations of teplizumab
Description
Pharmacokinetics endpoint
Time Frame
104 weeks
Secondary Outcome Measure Information:
Title
Serum concentration of ADA anti-drug antibodies (anti-teplizumab antibodies in ng/mL)
Description
Immunogenicity endpoint
Time Frame
104 weeks
Title
Serum concentration of NAb anti-drug antibodies (anti-teplizumab neutralizing antibodies in ng/mL)
Description
Immunogenticity endpoint
Time Frame
104 weeks
Title
Serum concentration of CD3 receptor occupancy on T cells
Description
Pharmacodynamic endpoint
Time Frame
104 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
VP Clinical Development, MD
Phone
6025243758
Email
Laura.Knecht@sanofi.com
First Name & Middle Initial & Last Name or Official Title & Degree
Study Director
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Provention Bio, Inc., MD
Organizational Affiliation
Provention Bio, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Site 107
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VP Clinical Development
Facility Name
Clinical Site 102
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VP Clinical Development, MD
Facility Name
Clinical Site 101
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VP Clinical Development, MD
Facility Name
Clinical Site 104
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VP Clinical Development, MD
Facility Name
Clinical Site 110
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VP Clinical Development
Facility Name
Clinical Site 105
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VP Clinical Development, MD
Facility Name
Site 109
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site 103
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VP Clinical Development, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Teplizumab in Pediatric Stage 2 Type 1 Diabetes

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