Teplizumab for Stage 3 Type 1 Diabetes in Children and Young Adults
This study is testing a medicine called teplizumab against a placebo (an inactive substance) in people aged 1 to 25 years who have recently been diagnosed with Stage 3 type 1 diabetes. All participants will also be on standard insulin therapy. The main goal is to see if teplizumab can help control blood sugar (measured by HbA1c) and reduce the need for insulin before meals over 52 weeks. For participants in Europe, the study will also look at how well the body produces its own insulin. Teplizumab and the placebo are both given through an IV (into a vein).
- Study design
- This is a Phase 3 study involving 723 participants. It is a randomized, double-blind study, meaning participants are randomly assigned to receive either teplizumab or placebo, and neither you nor your doctor will know which you are receiving.
- What's involved
- The study duration for each participant will be about 84 weeks (18 months).
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes are measured up to Week 52 after starting treatment.
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NCT07088068
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
Recruiting
PHASE3Ages 1–25InterventionalTreatmentSanofi
~723 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:TeplizumabPlacebo
At a glance
Recruiting sites
162 of 162 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
For United States (US) and non-European Union (EU) countries: Glycated hemoglobin (HbA1c) change from baseline
Measured over From Baseline to Week 52
+4 more outcomes measured
Conditions
Where it's being run
162 sites across 66 statesChina34
Belgium8
Spain7
France6
Germany6
Israel6
Japan6
Florida4
Who to contact
Trial Transparency email recommended (Toll free for US & Canada)
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants are eligible to be included in the study only if all of the following criteria apply:
Participant must be 1 to 25 years of age inclusive, at the time of signing the informed consent.
Participants diagnosed with T1D Stage 3 according to American Diabetes Association 2025 criteria
Participants able to be randomized and initiate study drug within 8 weeks (56 days) of the Stage 3 T1D diagnosis
Participants must be positive for at least one T1D autoantibody at screening:
Glutamic acid decarboxylase (GAD-65),
Insulinoma Antigen-2 (IA-2),
Zinc-transporter 8 (ZnT8), or
Insulin (if obtained not later than 14 days after exogenous insulin therapy initiation).
Islet cell cytoplasmic autoantibodies (ICAs)
Have random C-peptide level ≥0.2 nmol/L obtained at screening
Both male and female participants are eligible.
Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
A female participant is eligible to participate if she is not pregnant, and one of the following conditions applies:
Is a woman of nonchildbearing potential (WONCBP) OR
Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective, with a failure rate of \<1% during the study intervention period (to be effective before starting the intervention) and for at least 30 days after the last administration of study intervention.
A WOCBP must have a negative highly sensitive pregnancy test at screening (serum) and within 24 hours (urine or serum as required by local regulations) before the first administration of study intervention.
Lactating woman must interrupt breastfeeding and pump and discard breast milk during and for 20 days after last administration of study intervention.
Capable of giving signed informed consent as described in Appendix 1 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
Exclusion
Participant has diabetes other than autoimmune T1D that includes but is not limited to genetic forms of diabetes, maturity-onset diabetes of the young (MODY), diabetes secondary to medications or surgery and type 2 diabetes by judgement of the Investigator.
Participant has an active serious infection and/or fever ≥38.5°C (101.3°F) within the 48 hours prior to the first dose (except if localized skin infection), or has chronic, recurrent or opportunistic infectious disease.
At screening, participant has laboratory or clinical evidence of acute or clinically active infection with Epstein-Barr virus (EBV), cytomegalovirus (CMV).
At screening, participant has positive serology for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV).
Participant has evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and/or TB testing. Blood testing (eg, QuantiFERON® TB Gold test) is strongly preferred; if not available, any local approved TB test is allowed.
Has other autoimmune diseases, (eg, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythematosus etc), except clinically stable autoimmune thyroid disease, or controlled celiac disease (at discretion of Investigator).
Any clinically significant abnormality identified either in medical/surgical history or during screening evaluation (eg, physical examination, laboratory tests, vital signs), or any adverse event (AE) during screening period which, in the judgment of the investigator, would preclude safe completion of the study or constrains efficacy assessment.
Participant has recent or planned vaccinations as follows:
Live-attenuated (live) vaccines (eg, varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox) within the 8 weeks before first dose of the investigational medicinal product (IMP) or planned/required administration during treatment or up to 26 weeks after last IMP administration in any treatment course
Inactivated or mRNA vaccines within 2 weeks before the first dose of IMP or planned required administration during treatment or up to 6 weeks after last IMP administration in any treatment course.
Current or prior use (within 30 days before screening) of any anti-hyperglycemic agents other than insulin
Past (within 30 days prior to screening) or current administration of any treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, including but not limited to systemic corticosteroids (ie, oral, high doses of inhaled or injectable) with duration \>14 days, adrenocorticotropic hormone, verapamil).
Past systemic immunosuppression medicine or immune modulatory biologic therapy (such as monoclonal antibodies), within 3 months or 5 half-lifes (whichever is longer) prior to dosing.
Current or prior (within 30 days before screening) use of any medication known to significantly influence glucose tolerance (eg, atypical antipsychotics, diphenylhydantoin, niacin).
Participant has previously received teplizumab or other anti-CD3 treatment.
Other medications not compatible or interfering with IMP at discretion of Investigator.
Current enrollment OR past participation in another investigational study in which an investigational intervention (eg, drug, vaccine, invasive device) was administered within the last 8 weeks or 5 half-lifes, whichever is longer, prior to screening.
Participant has any of the following laboratory parameters, at screening prior to first dose:
Lymphocyte count: \<1000/µL,
Neutrophil count: \<1500/µL (\< 1000 /µL in participants with documented Duffy-null genotype),
Platelet count: \<150,000 platelets/µL,
Hemoglobin: \<10 g/dL,
Aspartate aminotransferase (AST) \>2.0 × upper limit of normal (ULN),
Alanine aminotransferase (ALT) \>2.0 × ULN,
Total bilirubin \>1.5 × ULN with the exception of participants with the diagnosis of Gilbert's syndrome who may be eligible provided they have no other causes leading to hyperbilirubinemia
What this trial measures
- For United States (US) and non-European Union (EU) countries: Glycated hemoglobin (HbA1c) change from baselineFrom Baseline to Week 52
- For US and non-EU countries: Total number of days without prandial insulin useFrom baseline to Week 52
- For EU countries: Change from baseline in mean 2 hours mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from Area Under the Curve (AUC) in participants 5 years and olderFrom baseline to Week 52
- For EU countries: HbA1c change from baselineFrom baseline to Week 52
- For EU countries: Total number of days without prandial insulin useFrom baseline to Week 52