Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
20 participants
INTERVENTIONAL
2023-07-25
2026-08-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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teplizumab injection
teplizumab injection, sterile solution for intravenous use
teplizumab
CD3-directed humanized monoclonal antibody
Interventions
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teplizumab
CD3-directed humanized monoclonal antibody
Eligibility Criteria
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Inclusion Criteria
2. Participant has Stage 2 T1D (two T1D-related autoantibodies and dysglycemia)
Exclusion Criteria
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.
0 Years
7 Years
ALL
No
Sponsors
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Provention Bio, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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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
Countries
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References
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Novograd J, Frishman WH. Teplizumab Therapy to Delay the Onset of Type 1 Diabetes. Cardiol Rev. 2024 Nov-Dec 01;32(6):572-576. doi: 10.1097/CRD.0000000000000563. Epub 2023 May 9.
Other Identifiers
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SFY18116
Identifier Type: OTHER
Identifier Source: secondary_id
PRV-031-005
Identifier Type: -
Identifier Source: org_study_id
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