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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05757713
Recruitment Status : Recruiting
First Posted : March 7, 2023
Last Update Posted : April 16, 2024
Sponsor:
Information provided by (Responsible Party):
Sanofi ( 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Biological: teplizumab Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, non-randomized, open-label, multi-center study
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : July 25, 2023
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: teplizumab injection
teplizumab injection, sterile solution for intravenous use
Biological: teplizumab
CD3-directed humanized monoclonal antibody




Primary Outcome Measures :
  1. Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), TEAEs leading to withdrawal, and serious adverse events (SAEs) [ Time Frame: Through 104 Weeks ]
    Safety and tolerability endpoint


Secondary Outcome Measures :
  1. Serum concentrations of teplizumab [ Time Frame: Sparse PK samples between Days 1 and 28 ]
    Pharmacokinetic (PK) endpoint

  2. Anti-drug antibody (ADA) titers and presence of neutralizing antibodies (Nab) [ Time Frame: Through 104 weeks ]
    Immunogenicity endpoint

  3. CD3 receptor occupancy [ Time Frame: Days 1 and 9 ]
    To assess the effects of teplizumab on cluster of differentiation 3 (CD3) receptor occupancy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   0 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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:

  1. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05757713


Contacts
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Contact: Trial Transparency email recommended (Toll free for US & Canada) 800-633-1610 ext option 6 Contact-us@sanofi.com

Locations
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United States, California
Clinical Site 107 Recruiting
San Francisco, California, United States, 94143
Contact: Clinical and Translational Medicine Lead         
United States, Colorado
Clinical Site 102 Recruiting
Aurora, Colorado, United States, 80045
Contact: Clinical and Translational Medicine Lead         
United States, Connecticut
Clinical Site 101 Recruiting
New Haven, Connecticut, United States, 06511
Contact: Clinical and Translational Medicine Lead         
United States, Georgia
Clinical Site 104 Recruiting
Columbus, Georgia, United States, 31904
Contact: Clinical and Translational Medicine Lead         
United States, Indiana
Clinical Site 110 Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Clinical and Translational Medicine Lead         
United States, New York
Clinical Site 105 Recruiting
Buffalo, New York, United States, 14203
Contact: Clinical and Translational Medicine Lead         
United States, Pennsylvania
Clinical Site 108 Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Clinical and Translational Medicine Lead         
United States, South Dakota
Clinical Site 106 Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Clinical and Translational Medicine Lead         
United States, Tennessee
Clinical Site 109 Recruiting
Nashville, Tennessee, United States, 37232
Contact: Clinical and Translational Medicine Lead         
United States, Washington
Clinical Site 103 Recruiting
Tacoma, Washington, United States, 98405
Contact: Clinical and Translational Medicine Lead         
Sponsors and Collaborators
Provention Bio, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Provention Bio, a Sanofi Company
ClinicalTrials.gov Identifier: NCT05757713    
Other Study ID Numbers: PRV-031-005
First Posted: March 7, 2023    Key Record Dates
Last Update Posted: April 16, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sanofi ( Provention Bio, a Sanofi Company ):
Type 1 diabetes
Stage 2
Pediatric type 1 diabetes
T1D
At-risk
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases