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ClinicalTrials.gov public records Last synced Oct 17, 2026, 7:37 AM EDT

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Showing 1–23 of 23 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Teplizumab Clear all
Recruiting No phase listed Observational

Long-Term Outcomes of Teplizumab in Routine Clinical Care

NCT07360080
View directory record Official record
Conditions
Type 1 Diabetes
Interventions
Teplizumab
Drug
Lead sponsor
Sanofi
Industry
Eligibility
Not listed
Enrollment
1,000 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2035
U.S. locations
5
States / cities
Atlanta, Georgia • New York, New York • Syosset, New York + 1 more
Source: ClinicalTrials.gov public record
Updated Aug 25, 2026 · Synced Oct 17, 2026, 7:37 AM EDT
Terminated Not applicable Interventional Results available

Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01)

NCT00870818
View directory record Official record
Conditions
Type 1 Diabetes Mellitus
Interventions
Blood samples for safety, Patient reported outcome questionnaires, Analysis of T-cell subsets
Diagnostic Test · Behavioral
Lead sponsor
MacroGenics
Industry
Eligibility
10 Years to 37 Years
Enrollment
219 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
1
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Aug 9, 2023 · Synced Oct 17, 2026, 7:37 AM EDT
Terminated Phase 3 Interventional Results available

Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

NCT00920582
View directory record Official record
Conditions
Type 1 Diabetes Mellitus
Interventions
Teplizumab Herold Regimen, Placebo, Teplizumab 33.3% Herold Regimen, Teplizumab Curtailed Herold Regimen
Biological · Drug
Lead sponsor
MacroGenics
Industry
Eligibility
8 Years to 35 Years
Enrollment
254 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2012
U.S. locations
42
States / cities
Birmingham, Alabama • Jonesboro, Arkansas • Little Rock, Arkansas + 37 more
Source: ClinicalTrials.gov public record
Updated Dec 20, 2023 · Synced Oct 17, 2026, 7:37 AM EDT
Completed Phase 3 Interventional Results available

Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab

NCT03875729
View directory record Official record
Conditions
Type 1 Diabetes Mellitus
Interventions
teplizumab, Placebo
Biological
Lead sponsor
Provention Bio, Inc.
Industry
Eligibility
8 Years to 17 Years
Enrollment
328 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
34
States / cities
San Diego, California • San Francisco, California • Walnut Creek, California + 30 more
Source: ClinicalTrials.gov public record
Updated Apr 24, 2024 · Synced Oct 17, 2026, 7:37 AM EDT
Completed Phase 1Phase 2 Interventional Results available

A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recent-onset Diagnosed Type 1 Diabetes (T1D)

NCT03751007
View directory record Official record
Conditions
Diabetes type1
Interventions
AG019 - Low Dose, Teplizumab, Placebo-AG019, Placebo-Teplizumab, AG019 - High Dose
Biological · Drug
Lead sponsor
Precigen Actobio T1D, LLC
Industry
Eligibility
12 Years to 40 Years
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
15
States / cities
Birmingham, Alabama • San Francisco, California • Ventura, California + 12 more
Source: ClinicalTrials.gov public record
Updated Feb 1, 2023 · Synced Oct 17, 2026, 7:37 AM EDT
Completed Phase 4 Interventional

Teplizumab in Pediatric Stage 2 Type 1 Diabetes

NCT05757713
View directory record Official record
Conditions
Diabetes Mellitus, Type 1
Interventions
teplizumab
Biological
Lead sponsor
Sanofi
Industry
Eligibility
0 Years to 7 Years
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
10
States / cities
San Francisco, California • Aurora, Colorado • New Haven, Connecticut + 7 more
Source: ClinicalTrials.gov public record
Updated Sep 29, 2026 · Synced Oct 17, 2026, 7:37 AM EDT
Recruiting Early Phase 1 Interventional

GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab

NCT06338553
View directory record Official record
Conditions
Type 1 Diabetes
Interventions
Semaglutide (Rybelsus®), Placebo
Drug
Lead sponsor
Vanderbilt University Medical Center
Other
Eligibility
12 Years to 50 Years
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Dec 18, 2025 · Synced Oct 17, 2026, 7:37 AM EDT
Completed No phase listed Observational

Description of Patients With Type 1 Diabetes Treated With Teplizumab

NCT06892002
View directory record Official record
Conditions
Type 1 Diabetes
Interventions
Teplizumab
Drug
Lead sponsor
Sanofi
Industry
Eligibility
Not listed
Enrollment
110 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025
U.S. locations
24
States / cities
Little Rock, Arkansas • San Francisco, California • Aurora, Colorado + 19 more
Source: ClinicalTrials.gov public record
Updated Aug 15, 2025 · Synced Oct 17, 2026, 7:37 AM EDT
Terminated Phase 2 Interventional Results available

PsA Treatment With hOKT3γ1 (Ala-Ala)

NCT00239720
View directory record Official record
Conditions
Arthritis, Psoriatic
Interventions
hOKT3gamma1(Ala-Ala), Placebo
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years and older
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2008
U.S. locations
2
States / cities
Aurora, Colorado • Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Apr 27, 2017 · Synced Oct 17, 2026, 7:37 AM EDT
Completed Phase 2 Interventional Results available

Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes

NCT00378508
View directory record Official record
Conditions
Type 1 Diabetes Mellitus
Interventions
mAb hOKT3gamma1(Ala-Ala), Teplizumab, Placebo Arm
Drug
Lead sponsor
Yale University
Other
Eligibility
8 Years to 30 Years
Enrollment
63 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2013
U.S. locations
4
States / cities
San Francisco, California • Aurora, Colorado • New Haven, Connecticut + 1 more
Source: ClinicalTrials.gov public record
Updated Aug 13, 2021 · Synced Oct 17, 2026, 7:37 AM EDT
Completed Phase 2 Interventional Results available

Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes

NCT00129259
View directory record Official record
Conditions
Diabetes Mellitus, Type 1
Interventions
Anti-CD3 mAb, Diabetes Standard of Care Treatment, Iron supplementation
Biological · Other · Dietary Supplement
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
8 Years to 30 Years
Enrollment
83 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2011
U.S. locations
7
States / cities
San Francisco, California • Denver, Colorado • New Haven, Connecticut + 3 more
Source: ClinicalTrials.gov public record
Updated May 22, 2017 · Synced Oct 17, 2026, 7:37 AM EDT
Completed Phase 2 Interventional Results available

Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"

NCT01030861
View directory record Official record
Conditions
Autoantibody Positive, Non-diabetic Relatives at Risk for Type 1 Diabetes, High Risk, Impaired Glucose Tolerance
Interventions
Teplizumab, Placebo infusion
Drug
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Eligibility
8 Years to 45 Years
Enrollment
76 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2019
U.S. locations
17
States / cities
San Francisco, California • Stanford, California • Denver, Colorado + 13 more
Source: ClinicalTrials.gov public record
Updated Aug 5, 2020 · Synced Oct 17, 2026, 7:37 AM EDT
Completed Phase 2Phase 3 Interventional Results available

The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

NCT00385697
View directory record Official record
Conditions
Type 1 Diabetes Mellitus
Interventions
Teplizumab, Placebo
Biological · Drug
Lead sponsor
MacroGenics
Industry
Eligibility
8 Years to 35 Years
Enrollment
554 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2011
U.S. locations
39
States / cities
Birmingham, Alabama • Jonesboro, Arkansas • Little Rock, Arkansas + 36 more
Source: ClinicalTrials.gov public record
Updated Dec 5, 2023 · Synced Oct 17, 2026, 7:37 AM EDT
Recruiting No phase listed Observational

A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United States

NCT07260110
View directory record Official record
Conditions
Type 1 Diabetes
Interventions
Teplizumab
Drug
Lead sponsor
Sanofi
Industry
Eligibility
8 Years and older
Enrollment
550 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2030
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Dec 3, 2025 · Synced Oct 17, 2026, 7:37 AM EDT
Completed No phase listed Observational

AbATE Follow-Up Study

NCT02067923
View directory record Official record
Conditions
Diabetes Mellitus, Type 1
Interventions
Not listed
Lead sponsor
Yale University
Other
Eligibility
10 Years to 37 Years
Enrollment
44 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Jan 17, 2018 · Synced Oct 17, 2026, 7:37 AM EDT
Recruiting No phase listed Observational

Registry for Stage 2 Type 1 Diabetes

NCT06481904
View directory record Official record
Conditions
Type 1 Diabetes
Interventions
TZIELD (teplizumab-mzwv)
Drug
Lead sponsor
Sanofi
Industry
Eligibility
Not listed
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2037
U.S. locations
37
States / cities
Los Angeles, California • San Francisco, California • Aurora, Colorado + 32 more
Source: ClinicalTrials.gov public record
Updated Apr 13, 2026 · Synced Oct 17, 2026, 7:37 AM EDT
Active, not recruiting No phase listed Observational

Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)

NCT04598893
View directory record Official record
Conditions
Diabetes Mellitus, Type 1
Interventions
Teplizumab, Placebo
Biological · Other
Lead sponsor
Provention Bio, a Sanofi Company
Industry
Eligibility
9 Years to 19 Years
Enrollment
188 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2026
U.S. locations
25
States / cities
San Diego, California • San Francisco, California • Walnut Creek, California + 22 more
Source: ClinicalTrials.gov public record
Updated Dec 9, 2025 · Synced Oct 17, 2026, 7:37 AM EDT
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

NCT07088068
View directory record Official record
Conditions
Type 1 Diabetes Mellitus
Interventions
Teplizumab, Placebo
Drug · Other
Lead sponsor
Sanofi
Industry
Eligibility
1 Year to 25 Years
Enrollment
723 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
34
States / cities
Scottsdale, Arizona • San Diego, California • San Francisco, California + 29 more
Source: ClinicalTrials.gov public record
Updated Oct 13, 2026 · Synced Oct 17, 2026, 7:37 AM EDT
Terminated Phase 1Phase 2 Interventional Results available

Safety Study of the Monoclonal Antibody Teplizumab (MGA031) in Subjects With Moderate or More Severe Psoriasis

NCT00954915
View directory record Official record
Conditions
Psoriasis
Interventions
teplizumab
Biological
Lead sponsor
MacroGenics
Industry
Eligibility
18 Years to 70 Years
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
2
States / cities
Ann Arbor, Michigan • Portland, Oregon
Source: ClinicalTrials.gov public record
Updated Feb 10, 2022 · Synced Oct 17, 2026, 7:37 AM EDT
Completed Phase 2 Interventional Results available

At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)

NCT04270942
View directory record Official record
Conditions
Diabetes Mellitus, Type 1
Interventions
teplizumab 1 mg/mL
Drug
Lead sponsor
Provention Bio, a Sanofi Company
Industry
Eligibility
Not listed
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
8
States / cities
Aurora, Colorado • New Haven, Connecticut • Gainesville, Florida + 1 more
Source: ClinicalTrials.gov public record
Updated Feb 12, 2025 · Synced Oct 17, 2026, 7:37 AM EDT
Not listed Phase 1Phase 2 Interventional

hOKT3gamma1 (Ala-Ala) for the Prevention of Human Islet Allograft Failure

NCT00008801
View directory record Official record
Conditions
Diabetes Mellitus, Insulin-Dependent, Diabetes Mellitus, Experimental, Transplantation, Homologous, Islets of Langerhans Transplantation
Interventions
hOKT3gamma1 (Ala-ala)
Drug
Lead sponsor
National Center for Research Resources (NCRR)
NIH
Eligibility
18 Years to 60 Years
Healthy volunteers
Healthy volunteers not accepted
U.S. locations
1
States / cities
Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Nov 1, 2005 · Synced Oct 17, 2026, 7:37 AM EDT
Recruiting Phase 2 Interventional

Platform Trial to Delay Stage 3 Diabetes: Comparing Teplizumab With ATG

NCT07216391
View directory record Official record
Conditions
Type 1 Diabetes Mellitus
Interventions
Antithymocyte Globulin (ATG), Teplizumab
Drug
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Eligibility
4 Years to 34 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2030
U.S. locations
6
States / cities
Aurora, Colorado • New Haven, Connecticut • Gainesville, Florida + 3 more
Source: ClinicalTrials.gov public record
Updated Sep 9, 2026 · Synced Oct 17, 2026, 7:37 AM EDT
Terminated Phase 2 Interventional

Treatment With hOKT3gamma1(Ala-Ala) in T1DM

NCT00806572
View directory record Official record
Conditions
Diabetes Mellitus, Type 1
Interventions
hOKT3gamma1(Ala-Ala)
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
7 Years to 30 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2007
U.S. locations
3
States / cities
San Francisco, California • New York, New York • Seattle, Washington
Source: ClinicalTrials.gov public record
Updated Feb 8, 2017 · Synced Oct 17, 2026, 7:37 AM EDT