9 completed, 6 recruiting, 5 terminated, 1 active not recruiting. 12 Phase 2, 5 Phase 1, 4 Phase 3, 1 Phase 4.
Follow teplizumab: new trials by email Literature Review of teplizumab trials Research Report on teplizumab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Sequential Immune Modulation and Antigen-Specific Tolerance Induction for Disease Modification in Recent-Onset Type 1 Diabetes Teplizumab, Intralymphatic Insulin Immunotherapy (ILIT) - Type 1 Diabetes Mellitus (T1DM), Type 1 Diabetes Mellitus | Phase 1 | Not yet recruiting | Abdullah Kars | 60 | 2027-01-01 | 2026-05-27 |
| Platform Trial to Delay Stage 3 Diabetes: Comparing Teplizumab With ATG Antithymocyte Globulin (ATG), Teplizumab - Type 1 Diabetes Mellitus | Phase 2 | Recruiting | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | 60 | 2026-07-29 | 2026-09-09 |
| Long-Term Outcomes of Teplizumab in Routine Clinical Care Teplizumab - Type 1 Diabetes | Recruiting | Sanofi | 1000 | 2026-03-19 | 2026-08-25 | |
| Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs) Teplizumab - Type 1 Diabetes | Recruiting | Sanofi | 60 | 2026-03-16 | 2026-08-26 | |
| A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United States Teplizumab - Type 1 Diabetes | Recruiting | Sanofi | 550 | 2025-10-31 | 2025-12-03 | |
| 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 Teplizumab, Placebo - Type 1 Diabetes Mellitus | Phase 3 | Recruiting | Sanofi | 723 | 2025-08-06 | 2026-10-13 |
| Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes Teplizumab - Type 1 Diabetes Mellitus | Phase 2 | Recruiting | Sanofi | 10 | 2025-07-25 | 2026-10-13 |
| Description of Patients With Type 1 Diabetes Treated With Teplizumab Teplizumab - Type 1 Diabetes | Completed | Sanofi | 110 | 2025-02-11 | 2025-08-15 | |
| Teplizumab in Pediatric Stage 2 Type 1 Diabetes teplizumab - Diabetes Mellitus, Type 1 | Phase 4 | Completed | Sanofi | 23 | 2023-07-25 | 2026-09-29 |
| Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension) Teplizumab, Placebo - Diabetes Mellitus, Type 1 | Active not recruiting | Provention Bio, a Sanofi Company | 188 | 2020-10-26 | 2025-12-09 | |
| At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension) teplizumab 1 mg/mL - Diabetes Mellitus, Type 1 | Phase 2 | Completed | Provention Bio, a Sanofi Company | 6 | 2020-02-26 | 2025-02-12 |
| Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab teplizumab, Placebo - Type 1 Diabetes Mellitus | Phase 3 | Completed | Provention Bio, Inc. | 328 | 2019-04-05 | 2024-04-24 |
| 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) AG019 - Low Dose, Teplizumab, Placebo-AG019 - Diabetes type1 | Phase 1 / Phase 2 | Completed | Precigen Actobio T1D, LLC | 45 | 2018-10-24 | 2023-02-01 |
| Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk" Teplizumab, Placebo infusion - Autoantibody Positive, Non-diabetic Relatives at Risk for Type 1 Diabetes | Phase 2 | Completed | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | 76 | 2010-08-01 | 2020-08-05 |
| Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes teplizumab or placebo - Type 1 Diabetes Mellitus | Phase 1 | Terminated | MacroGenics | 1 | 2010-08-01 | 2022-02-08 |
| Safety Study of the Monoclonal Antibody Teplizumab (MGA031) in Subjects With Moderate or More Severe Psoriasis teplizumab - Psoriasis | Phase 1 / Phase 2 | Terminated | MacroGenics | 1 | 2009-12-01 | 2022-02-10 |
| Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus Teplizumab Herold Regimen, Placebo, Teplizumab 33.3% Herold Regimen - Type 1 Diabetes Mellitus | Phase 3 | Terminated | MacroGenics | 254 | 2009-09-01 | 2023-12-20 |
| The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus Teplizumab, Placebo - Type 1 Diabetes Mellitus | Phase 2 / Phase 3 | Completed | MacroGenics | 554 | 2006-10-01 | 2023-12-05 |
| Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes mAb hOKT3gamma1(Ala-Ala), Teplizumab, Placebo Arm - Type 1 Diabetes Mellitus | Phase 2 | Completed | Yale University | 63 | 2006-09-01 | 2021-08-13 |
| PsA Treatment With hOKT3γ1 (Ala-Ala) hOKT3gamma1(Ala-Ala), Placebo - Arthritis, Psoriatic | Phase 2 | Terminated | National Institute of Allergy and Infectious Diseases (NIAID) | 4 | 2006-03-16 | 2017-04-27 |
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Diabetes Mellitus, Type 1 (20) · Arthritis, Psoriatic (2) · Diabetes Mellitus (2) · Psoriasis (2) · Arthritis (1) · Autoimmune Diseases (1) · Diabetes Mellitus, Experimental (1) · Disease Progression (1) · Glucose Intolerance (1)
Sanofi (7) · MacroGenics (4) · National Institute of Allergy and Infectious Diseases (NIAID) (3) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (2) · Provention Bio, a Sanofi Company (2) · Abdullah Kars (1) · National Center for Research Resources (NCRR) (1) · Precigen Actobio T1D, LLC (1) · Provention Bio, Inc. (1) · Yale University (1)
United States (19) · Germany (7) · Belgium (6) · United Kingdom (6) · Canada (5) · Czechia (5) · France (5) · Israel (5) · Poland (5) · Spain (4) · Italy (3) · Netherlands (3) · Romania (3) · India (2) · Japan (2)
Kevan Herold, MD (2) · Carla J Greenbaum, MD (1) · Chantal Mathieu, MD (1) · David Baidal, MD (1) · Jeffrey A Bluestone, PhD (1) · Kevan C Herold (1) · Kevan C Herold, MD (1) · Marcus Clark, MD (1) · Michael Haller, MD (1) · Vandana Raman, MD, MBBS (1)
PMID 39735417, PMID 37158990, PMID 24115337, PMID 19443276, PMID 21719095, PMID 23086558, PMID 23423576, PMID 23835333, PMID 27208317, PMID 31180194, PMID 35713929, PMID 36220750, PMID 37782353, PMID 37861217, PMID 39137044, PMID 41196293, PMID 41480032, PMID 42720752
2017 (1), R01DK057846 (1), UC4DK106993 (1)