Teplizumab
Sponsors
Provention Bio Inc., Sanofi-Aventis Recherche & Developpement, MacroGenics, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Precigen Actobio T1D, LLC
Conditions
Autoantibody PositiveDiabetes Mellitus, Type 1Diabetes type1High RiskImpaired Glucose ToleranceNon-diabetic Relatives at Risk for Type 1 DiabetesNutritional and metabolic diseasesPsoriasis
Phase 1
Safety Study of the Monoclonal Antibody Teplizumab (MGA031) in Subjects With Moderate or More Severe Psoriasis
TerminatedNCT00954915
Start: 2009-12-31End: 2010-07-31Updated: 2022-02-10
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)
CompletedNCT03751007
Start: 2018-10-24End: 2021-10-13Updated: 2023-02-01
Phase 2
The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
CompletedNCT00385697
Start: 2006-10-31End: 2011-08-31Updated: 2023-12-05
Teplizumab for Prevention of Type 1 Diabetes In Relatives At-Risk
CompletedNCT01030861
Start: 2010-08-31End: 2019-06-30Updated: 2020-08-05
Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes
RecruitingNCT06791291
Start: 2025-07-25End: 2028-03-06Target: 10Updated: 2025-12-24
Platform Trial to Delay Stage 3 Diabetes: Comparing Teplizumab With ATG
Not yet recruitingNCT07216391
Start: 2026-04-15End: 2030-05-30Target: 60Updated: 2026-02-20
Phase 3
Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab
CompletedNCT03875729
Start: 2019-04-05End: 2023-05-01Updated: 2024-04-24
A Multicenter, Multinational Extension of Study PRV-031-001 to Evaluate the Long-Term Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adolescents with Recent-Onset Type 1 Diabetes Mellitus
Active, not recruitingCTIS2024-516543-26-00
Start: 2021-07-23Target: 66Updated: 2025-09-25
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
RecruitingNCT07088068
Start: 2025-08-06End: 2028-12-12Target: 723Updated: 2026-03-23
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) (βETA PRESERVE)
RecruitingCTIS2024-519494-19-00
Start: 2025-12-22Target: 467Updated: 2025-11-30
Phase 4
Unknown Phase
Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)
Active, not recruitingNCT04598893
Start: 2020-10-26End: 2026-11-30Updated: 2025-12-09
Description of Patients With Type 1 Diabetes Treated With Teplizumab
CompletedNCT06892002
Start: 2025-02-11End: 2025-08-05Updated: 2025-08-15
A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United States
RecruitingNCT07260110
Start: 2025-10-31End: 2030-12-03Target: 550Updated: 2025-12-03
Long-Term Outcomes of Teplizumab in Routine Clinical Care
RecruitingNCT07360080
Start: 2026-03-19End: 2035-10-29Target: 1000Updated: 2026-03-30
Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)
RecruitingNCT07457580
Start: 2026-03-16End: 2026-11-30Target: 60Updated: 2026-03-23