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Recruiting Phase 3 Interventional

A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes

ClinicalTrials.gov ID: NCT07088068

Public ClinicalTrials.gov record NCT07088068. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 16, 2026, 1:51 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-blind, Phase 3 Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Recently Diagnosed Stage 3 Type 1 Diabetes (T1D)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase 3, 2-arm study for treatment. The purpose of this study is to measure change in glycemic control and prandial insulin independency over 52 weeks with teplizumab compared with placebo, both administered by intravenous (IV) infusion, in participants with recently diagnosed Stage 3 type 1 diabetes (T1D) aged 1 to 25 years, on standard insulin therapy.

Study identification

NCT ID
NCT07088068
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sanofi
Industry
Enrollment
723 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
1 Year to 25 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 6, 2025 (Actual)
Primary completion
Jun 6, 2028 (Estimated)
Completion
Dec 12, 2028 (Estimated)
Last update posted
Oct 13, 2026

2025 – 2028

United States locations

U.S. sites
34
U.S. states
20
U.S. cities
32
Facility City State ZIP Site status
Scottsdale Clinical Trials- Site Number : 8400044 Scottsdale Arizona 85260 Recruiting
Rady Children's Hospital- Site Number : 8400002 San Diego California 92123 Recruiting
University of California San Francisco - Mission Bay- Site Number : 8400011 San Francisco California 94158 Recruiting
Barbara Davis Center for Childhood Diabetes- Site Number : 8400031 Aurora Colorado 80045 Recruiting
Yale University School of Medicine- Site Number : 8400005 New Haven Connecticut 06510 Recruiting
University of Florida College of Medicine- Site Number : 8400054 Gainesville Florida 32610 Recruiting
Encore Medical Research - Hollywood- Site Number : 8400061 Hollywood Florida 33024 Recruiting
Nemours Children's Speciality Care- Jacksonville- Site Number : 8400040 Jacksonville Florida 32207 Recruiting
University of South Florida- Site Number : 8400013 Tampa Florida 33612 Recruiting
AdventHealth Winter Park- Site Number : 8400033 Winter Park Florida 32792 Recruiting
Atlanta Diabetes Associates- Site Number : 8400036 Atlanta Georgia 30318 Recruiting
Children's Healthcare of Atlanta - Egleston Hospital- Site Number : 8400065 Atlanta Georgia 30322 Recruiting
IACT Health - Columbus - Talbotton Road- Site Number : 8400003 Columbus Georgia 31904 Recruiting
St. Luke's Children's Hospital- Site Number : 8400014 Boise Idaho 83712 Recruiting
Rocky Mountain Clinical Research - Idaho Falls- Site Number : 8400001 Idaho Falls Idaho 83404 Recruiting
Norton Children's Research Institute - Wendy Novak Diabetes Institute- Site Number : 8400016 Louisville Kentucky 40202 Recruiting
C.S. Mott Children's Hospital- Site Number : 8400015 Ann Arbor Michigan 48109 Recruiting
Mayo Clinic in Rochester - Minnesota- Site Number : 8400019 Rochester Minnesota 55905 Recruiting
Park Nicollet Institute - Oncology Research- Site Number : 8400059 Saint Louis Park Minnesota 55426 Recruiting
Children's Mercy Adelle Hall Campus- Site Number : 8400010 Kansas City Missouri 64108 Recruiting
University At Buffalo - Jacobs School Of Medicine- Site Number : 8400006 Buffalo New York 14203 Recruiting
Endocrine Associates of West Village- Site Number : 8400064 New York New York 10001 Recruiting
Columbia University Irving Medical Center- Site Number : 8400009 New York New York 10032 Recruiting
Asheville Clinical Research- Site Number : 8400045 Asheville North Carolina 28803 Recruiting
UNC Children's Hospital- Site Number : 8400034 Chapel Hill North Carolina 27599 Recruiting
Cincinnati Children's Hospital Medical Center- Site Number : 8400018 Cincinnati Ohio 45229 Recruiting
The Ohio State University- Site Number : 8400051 Columbus Ohio 43210 Recruiting
The Children's Hospital of Philadelphia- Site Number : 8400039 Philadelphia Pennsylvania 19104 Recruiting
AM Diabetes & Endocrinology Center- Site Number : 8400004 Bartlett Tennessee 38133 Recruiting
Baylor College of Medicine- Site Number : 8400057 Houston Texas 77030 Recruiting
University of Utah Health Hospital- Site Number : 8400052 Salt Lake City Utah 84132 Recruiting
Uva Children's Battle Building- Site Number : 8400060 Charlottesville Virginia 22903 Recruiting
Benaroya Research Institute at Virginia Mason- Site Number : 8400038 Seattle Washington 98101 Recruiting
MultiCare Mary Bridge Children's Health Center- Site Number : 8400037 Tacoma Washington 98405 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 168 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07088068, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 13, 2026 · Synced Oct 16, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07088068 live on ClinicalTrials.gov.

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