RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Sanofi • ClinicalTrials.gov ID: NCT07088068

Registry updated: 2026-10-13

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Description

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.

Interventions

Teplizumab (Drug)
Pharmaceutical form: Concentrated solution for infusion Route of administration: Intravenous infusion
Placebo (Other)
Pharmaceutical form: Concentrated solution for infusion Route of administration: Intravenous infusion

Eligibility criteria

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.

Conditions

Type 1 Diabetes Mellitus

Locations

Scottsdale Clinical Trials- Site Number : 8400044 — Scottsdale, Arizona, United States
Rady Children's Hospital- Site Number : 8400002 — San Diego, California, United States
University of California San Francisco - Mission Bay- Site Number : 8400011 — San Francisco, California, United States
Barbara Davis Center for Childhood Diabetes- Site Number : 8400031 — Aurora, Colorado, United States
Yale University School of Medicine- Site Number : 8400005 — New Haven, Connecticut, United States
University of Florida College of Medicine- Site Number : 8400054 — Gainesville, Florida, United States
Encore Medical Research - Hollywood- Site Number : 8400061 — Hollywood, Florida, United States
Nemours Children's Speciality Care- Jacksonville- Site Number : 8400040 — Jacksonville, Florida, United States
University of South Florida- Site Number : 8400013 — Tampa, Florida, United States
AdventHealth Winter Park- Site Number : 8400033 — Winter Park, Florida, United States
Atlanta Diabetes Associates- Site Number : 8400036 — Atlanta, Georgia, United States
Children's Healthcare of Atlanta - Egleston Hospital- Site Number : 8400065 — Atlanta, Georgia, United States
IACT Health - Columbus - Talbotton Road- Site Number : 8400003 — Columbus, Georgia, United States
St. Luke's Children's Hospital- Site Number : 8400014 — Boise, Idaho, United States
Rocky Mountain Clinical Research - Idaho Falls- Site Number : 8400001 — Idaho Falls, Idaho, United States
Norton Children's Research Institute - Wendy Novak Diabetes Institute- Site Number : 8400016 — Louisville, Kentucky, United States
C.S. Mott Children's Hospital- Site Number : 8400015 — Ann Arbor, Michigan, United States
Mayo Clinic in Rochester - Minnesota- Site Number : 8400019 — Rochester, Minnesota, United States
Park Nicollet Institute - Oncology Research- Site Number : 8400059 — Saint Louis Park, Minnesota, United States
Children's Mercy Adelle Hall Campus- Site Number : 8400010 — Kansas City, Missouri, United States
University At Buffalo - Jacobs School Of Medicine- Site Number : 8400006 — Buffalo, New York, United States
Endocrine Associates of West Village- Site Number : 8400064 — New York, New York, United States
Columbia University Irving Medical Center- Site Number : 8400009 — New York, New York, United States
Asheville Clinical Research- Site Number : 8400045 — Asheville, North Carolina, United States
UNC Children's Hospital- Site Number : 8400034 — Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center- Site Number : 8400018 — Cincinnati, Ohio, United States
The Ohio State University- Site Number : 8400051 — Columbus, Ohio, United States
The Children's Hospital of Philadelphia- Site Number : 8400039 — Philadelphia, Pennsylvania, United States
AM Diabetes & Endocrinology Center- Site Number : 8400004 — Bartlett, Tennessee, United States
Baylor College of Medicine- Site Number : 8400057 — Houston, Texas, United States
University of Utah Health Hospital- Site Number : 8400052 — Salt Lake City, Utah, United States
Uva Children's Battle Building- Site Number : 8400060 — Charlottesville, Virginia, United States
Benaroya Research Institute at Virginia Mason- Site Number : 8400038 — Seattle, Washington, United States
MultiCare Mary Bridge Children's Health Center- Site Number : 8400037 — Tacoma, Washington, United States
Investigational Site Number : 0320008 — Mar del Plata, Buenos Aires, Argentina
Investigational Site Number : 0320003 — San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320005 — Buenos Aires, Argentina
Investigational Site Number : 0320013 — Córdoba, Argentina
Investigational Site Number : 0320002 — Salta, Argentina
Investigational Site Number : 0320012 — Santa Fe, Argentina
Investigational Site Number : 0360001 — Brisbane, Queensland, Australia
Investigational Site Number : 0360003 — Adelaide, South Australia, Australia
Investigational Site Number : 0360002 — Perth, Western Australia, Australia
Investigational Site Number : 0560005 — Brussels, Belgium
Investigational Site Number : 0560009 — Brussels, Belgium
Investigational Site Number : 0560007 — Edegem, Belgium
Investigational Site Number : 0560002 — Jette, Belgium
Investigational Site Number : 0560001 — Leuven, Belgium
Investigational Site Number : 0560008 — Leuven, Belgium
Investigational Site Number : 0560006 — Liège, Belgium
Investigational Site Number : 0560004 — Namur, Belgium
Hospital Universitario Walter Cantidio- Site Number : 0760009 — Fortaleza, Ceará, Brazil
Centro de Diabetes Curitiba- Site Number : 0760006 — Curitiba, Paraná, Brazil
Centro de Pesquisa Clínica de Marília - CPCLIM- Site Number : 0760002 — Marília, São Paulo, Brazil
Hospital Universitario Clementino Fraga Filho- Site Number : 0760008 — Rio de Janeiro, Brazil
Centro de Pesquisas Clínicas - São Paulo- Site Number : 0760011 — São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760012 — São Paulo, Brazil
Hospital Israelita Albert Einstein- Site Number : 0760001 — São Paulo, Brazil
Investigational Site Number : 1240008 — Calgary, Alberta, Canada
Investigational Site Number : 1240009 — Vancouver, British Columbia, Canada
Investigational Site Number : 1240002 — Halifax, Nova Scotia, Canada
Investigational Site Number : 1240007 — Ottawa, Ontario, Canada
Investigational Site Number : 1560035 — Beijing, China
Investigational Site Number : 1560003 — Beijing, China
Investigational Site Number : 1560033 — Beijing, China
Investigational Site Number : 1560009 — Changchun, China
Investigational Site Number : 1560001 — Changsha, China
Investigational Site Number : 1560055 — Chengdu, China
Investigational Site Number : 1560042 — Chengdu, China
Investigational Site Number : 1560007 — Guangzhou, China
Investigational Site Number : 1560037 — Guangzhou, China
Investigational Site Number : 1560040 — Hangzhou, China
Investigational Site Number : 1560014 — Hangzhou, China
Investigational Site Number : 1560012 — Hangzhou, China
Investigational Site Number : 1560010 — Harbin, China
Investigational Site Number : 1560026 — Hohhot, China
Investigational Site Number : 1560059 — Jinan, China
Investigational Site Number : 1560056 — Lanzhou, China
Investigational Site Number : 1560016 — Luoyang, China
Investigational Site Number : 1560018 — Nanchang, China
Investigational Site Number : 1560043 — Nanchang, China
Investigational Site Number : 1560005 — Nanjing, China
Investigational Site Number : 1560034 — Nanjing, China
Investigational Site Number : 1560054 — Nanjing, China
Investigational Site Number : 1560050 — Pingxiang, China
Investigational Site Number : 1560031 — Shanghai, China
Investigational Site Number : 1560032 — Shanghai, China
Investigational Site Number : 1560013 — Shenyang, China
Investigational Site Number : 1560045 — Shenzhen, China
Investigational Site Number : 1560019 — Tianjin, China
Investigational Site Number : 1560039 — Wuhan, China
Investigational Site Number : 1560002 — Wuhan, China
Investigational Site Number : 1560041 — Wuxi, China
Investigational Site Number : 1560060 — Yueyang, China
Investigational Site Number : 1560038 — Zhengzhou, China
Investigational Site Number : 1560027 — Zhenjiang, China
Investigational Site Number : 2030004 — Prague, Czechia
Investigational Site Number : 2030003 — Prague, Czechia
Investigational Site Number : 2030001 — Prague, Czechia
Investigational Site Number : 2500004 — Bron, France
Investigational Site Number : 2500010 — La Tronche, France
Investigational Site Number : 2500011 — Lille, France
Investigational Site Number : 2500002 — Paris, France
Investigational Site Number : 2500008 — Paris, France
Investigational Site Number : 2500001 — Paris, France
Investigational Site Number : 2500009 — Paris, France
Investigational Site Number : 2500005 — Pau, France
Investigational Site Number : 2500007 — Strasbourg, France
Investigational Site Number : 2760002 — Augsburg, Germany
Investigational Site Number : 2760008 — Bielefeld, Germany
Investigational Site Number : 2760007 — Dresden, Germany
Investigational Site Number : 2760012 — Frankfurt, Germany
Investigational Site Number : 2760003 — Freiburg im Breisgau, Germany
Investigational Site Number : 2760005 — Hanover, Germany
Investigational Site Number : 2760006 — Leipzig, Germany
Investigational Site Number : 2760010 — Munich, Germany
Investigational Site Number : 2760001 — Ulm, Germany
Investigational Site Number : 3000005 — Athens, Greece
Investigational Site Number : 3000001 — Athens, Greece
Investigational Site Number : 3000004 — Athens, Greece
Investigational Site Number : 3000003 — Thessaloniki, Greece
Investigational Site Number : 3760005 — Jerusalem, Israel
Investigational Site Number : 3760002 — Petah Tikva, Israel
Investigational Site Number : 3760003 — Petah Tikva, Israel
Investigational Site Number : 3760001 — Ramat Gan, Israel
Investigational Site Number : 3760006 — Rehovot, Israel
Investigational Site Number : 3760004 — Tel Aviv, Israel
Investigational Site Number : 3800001 — Florence, Firenze, Italy
Investigational Site Number : 3800008 — Genoa, Genova, Italy
Investigational Site Number : 3800005 — Milan, Milano, Italy
Investigational Site Number : 3800011 — Milan, Milano, Italy
Investigational Site Number : 3800012 — Rome, Roma, Italy
Investigational Site Number : 3800003 — Rome, Roma, Italy
Investigational Site Number : 3800010 — Turin, Torino, Italy
Investigational Site Number : 3800004 — Bologna, Italy
Investigational Site Number : 3800014 — Messina, Italy
Investigational Site Number : 3800015 — Novara, Italy
Investigational Site Number : 3800016 — Pescara, Italy
Investigational Site Number : 3800013 — Siena, Italy
Investigational Site Number : 3800002 — Verona, Italy
Investigational Site Number : 3920020 — Nagoya, Aichi-ken, Japan
Investigational Site Number : 3920001 — Sapporo, Hokkaido, Japan
Investigational Site Number : 3920003 — Kobe, Hyōgo, Japan
Investigational Site Number : 3920023 — Yokohama, Kanagawa, Japan
Investigational Site Number : 3920011 — Azumino, Nagano, Japan
Investigational Site Number : 3920008 — Shimajiri, Okinawa, Japan
Investigational Site Number : 3920025 — Iruma, Saitama, Japan
Investigational Site Number : 3920007 — Koshigaya, Saitama, Japan
Investigational Site Number : 3920010 — Moriyama, Shiga, Japan
Investigational Site Number : 3920022 — Chiba, Japan
Investigational Site Number : 3920005 — Fukuoka, Japan
Investigational Site Number : 3920015 — Kyoto, Japan
Investigational Site Number : 3920017 — Nara, Japan
Investigational Site Number : 3920006 — Niigata, Japan
Investigational Site Number : 3920002 — Osaka, Japan
Investigational Site Number : 3920012 — Shizuoka, Japan
Investigational Site Number : 3920013 — Tokyo, Japan
Investigational Site Number : 3920014 — Tokyo, Japan
Investigational Site Number : 3920021 — Tokyo, Japan
Investigational Site Number : 3920026 — Tokyo, Japan
Investigational Site Number : 3920016 — Tokyo, Japan
Investigational Site Number : 5280003 — Amersfoort, Netherlands
Investigational Site Number : 5280002 — Leiden, Netherlands
Investigational Site Number : 5280001 — Rotterdam, Netherlands
Investigational Site Number : 6160004 — Lublin, Lublin Voivodeship, Poland
Investigational Site Number : 6160005 — Lodz, Lódzkie, Poland
Investigational Site Number : 6160008 — Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160001 — Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160003 — Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160006 — Bialystok, Poland
Investigational Site Number : 6420001 — Bacau, Romania
Investigational Site Number : 6420003 — Iași, Romania
Investigational Site Number : 7240012 — Santiago de Compostela, A Coruña [La Coruña], Spain
Investigational Site Number : 7240001 — Seville, Andalusia, Spain
Investigational Site Number : 7240004 — Esplugues de Llobregat, Barcelona [Barcelona], Spain
Investigational Site Number : 7240020 — Bizkaia, Basque Country, Spain
Investigational Site Number : 7240017 — Barcelona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240023 — Alcalá de Henares, Madrid, Spain
Investigational Site Number : 7240009 — Madrid, Madrid, Comunidad de, Spain
Investigational Site Number : 7240011 — Madrid, Madrid, Comunidad de, Spain
Investigational Site Number : 7240007 — Madrid, Madrid, Comunidad de, Spain
Investigational Site Number : 7240016 — Pamplona, Navarre, Spain
Investigational Site Number : 7240014 — Vigo, Pontevedra [Pontevedra], Spain
Investigational Site Number : 7240019 — San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Investigational Site Number : 7240021 — Seville, Sevilla, Spain
Investigational Site Number : 7240006 — Madrid, Spain
Investigational Site Number : 7240010 — Madrid, Spain
Investigational Site Number : 7240022 — Málaga, Spain
Investigational Site Number : 7240015 — Palma, Spain
Investigational Site Number : 7240003 — Sabadell, Spain
Investigational Site Number : 7560002 — Basel, Switzerland
Investigational Site Number : 8260001 — Cambridge, Cambridgeshire, United Kingdom
Investigational Site Number : 8260004 — Dundee, Dundee City, United Kingdom
Investigational Site Number : 8260009 — London, England, United Kingdom
Investigational Site Number : 8260012 — London, England, United Kingdom
Investigational Site Number : 8260002 — Glasgow, Glasgow City, United Kingdom
Investigational Site Number : 8260007 — London, London, City of, United Kingdom
Investigational Site Number : 8260011 — Bath, Somerset, United Kingdom
Investigational Site Number : 8260006 — Guildford, Surrey, United Kingdom
Investigational Site Number : 8260005 — Leeds, United Kingdom
Investigational Site Number : 8260010 — Reading, United Kingdom
Investigational Site Number : 8260003 — Sheffield, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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