Recruiting
Phase 3

Teplizumab

Sponsor:

Sanofi

Code:

NCT07088068

Conditions

Type 1 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 1 - 25

Healthy Volunteers: Not accepted

Interventions

Teplizumab

Placebo

Study Details

Brief summary:

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.

Conditions

Type 1 Diabetes Mellitus

Study ID

NCT07088068

Start date

Aug 6, 2025

Status verified date

Oct, 2026

Completion date

Dec 12, 2028

Anticipated

Primary completion date

Jun 6, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 25

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • Enter Inclusion Criteria Sex
  • 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.

Note: For minor participants, a specific ICF must also be signed by the participant's legally authorized representative (LAR).

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • 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

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Design

Enrollment

723 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Teplizumab

Participants will receive teplizumab in increasing doses by intravenous administration

placebo comparator: Placebo

Participants will receive volume matching placebo doses to the Teplizumab arm by intravenous administration

Interventions

Teplizumab

Pharmaceutical form: Concentrated solution for infusion Route of administration: Intravenous infusion

Placebo

Pharmaceutical form: Concentrated solution for infusion Route of administration: Intravenous infusion

Primary outcome measure

  • For United States (US) and non-European Union (EU) countries: Glycated hemoglobin (HbA1c) change from baseline [ Time Frame: From Baseline to Week 52 ]
  • For US and non-EU countries: Total number of days without prandial insulin use [ Time Frame: From 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 older [ Time Frame: From baseline to Week 52 ]
  • For EU countries: HbA1c change from baseline [ Time Frame: From baseline to Week 52 ]
  • For EU countries: Total number of days without prandial insulin use [ Time Frame: From baseline to Week 52 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610contact-us@sanofi.com

Locations

Scottsdale Clinical Trials- Site Number : 8400044

Recruiting

Scottsdale, Arizona, United States, 85260

Rady Children's Hospital- Site Number : 8400002

Recruiting

San Diego, California, United States, 92123

University of California San Francisco - Mission Bay- Site Number : 8400011

Recruiting

San Francisco, California, United States, 94158

Barbara Davis Center for Childhood Diabetes- Site Number : 8400031

Recruiting

Aurora, Colorado, United States, 80045

Yale University School of Medicine- Site Number : 8400005

Recruiting

New Haven, Connecticut, United States, 06510

University of Florida College of Medicine- Site Number : 8400054

Recruiting

Gainesville, Florida, United States, 32610

Encore Medical Research - Hollywood- Site Number : 8400061

Recruiting

Hollywood, Florida, United States, 33024

Nemours Children's Speciality Care- Jacksonville- Site Number : 8400040

Recruiting

Jacksonville, Florida, United States, 32207

University of South Florida- Site Number : 8400013

Recruiting

Tampa, Florida, United States, 33612

AdventHealth Winter Park- Site Number : 8400033

Recruiting

Winter Park, Florida, United States, 32792

Atlanta Diabetes Associates- Site Number : 8400036

Recruiting

Atlanta, Georgia, United States, 30318

Children's Healthcare of Atlanta - Egleston Hospital- Site Number : 8400065

Recruiting

Atlanta, Georgia, United States, 30322

IACT Health - Columbus - Talbotton Road- Site Number : 8400003

Recruiting

Columbus, Georgia, United States, 31904

St. Luke's Children's Hospital- Site Number : 8400014

Recruiting

Boise, Idaho, United States, 83712

Rocky Mountain Clinical Research - Idaho Falls- Site Number : 8400001

Recruiting

Idaho Falls, Idaho, United States, 83404

Norton Children's Research Institute - Wendy Novak Diabetes Institute- Site Number : 8400016

Recruiting

Louisville, Kentucky, United States, 40202

C.S. Mott Children's Hospital- Site Number : 8400015

Recruiting

Ann Arbor, Michigan, United States, 48109

Mayo Clinic in Rochester - Minnesota- Site Number : 8400019

Recruiting

Rochester, Minnesota, United States, 55905

Park Nicollet Institute - Oncology Research- Site Number : 8400059

Recruiting

Saint Louis Park, Minnesota, United States, 55426

Children's Mercy Adelle Hall Campus- Site Number : 8400010

Recruiting

Kansas City, Missouri, United States, 64108

University At Buffalo - Jacobs School Of Medicine- Site Number : 8400006

Recruiting

Buffalo, New York, United States, 14203

Endocrine Associates of West Village- Site Number : 8400064

Recruiting

New York, New York, United States, 10001

Columbia University Irving Medical Center- Site Number : 8400009

Recruiting

New York, New York, United States, 10032

Asheville Clinical Research- Site Number : 8400045

Recruiting

Asheville, North Carolina, United States, 28803

UNC Children's Hospital- Site Number : 8400034

Recruiting

Chapel Hill, North Carolina, United States, 27599

Cincinnati Children's Hospital Medical Center- Site Number : 8400018

Recruiting

Cincinnati, Ohio, United States, 45229

The Ohio State University- Site Number : 8400051

Recruiting

Columbus, Ohio, United States, 43210

The Children's Hospital of Philadelphia- Site Number : 8400039

Recruiting

Philadelphia, Pennsylvania, United States, 19104

AM Diabetes & Endocrinology Center- Site Number : 8400004

Recruiting

Bartlett, Tennessee, United States, 38133

Baylor College of Medicine- Site Number : 8400057

Recruiting

Houston, Texas, United States, 77030

University of Utah Health Hospital- Site Number : 8400052

Recruiting

Salt Lake City, Utah, United States, 84132

Uva Children's Battle Building- Site Number : 8400060

Recruiting

Charlottesville, Virginia, United States, 22903

Benaroya Research Institute at Virginia Mason- Site Number : 8400038

Recruiting

Seattle, Washington, United States, 98101

MultiCare Mary Bridge Children's Health Center- Site Number : 8400037

Recruiting

Tacoma, Washington, United States, 98405

Investigational Site Number : 1240008

Recruiting

Calgary, Alberta, Canada, T2N 4L7

Investigational Site Number : 1240009

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Investigational Site Number : 1240002

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Investigational Site Number : 1240007

Recruiting

Ottawa, Ontario, Canada, K1H 8L1

More Information

Sponsor

Sanofi

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Sanofi on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.