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RECRUITING

NCT07088068

PHASE3

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

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

1 Year - 25 Years

Study Type

INTERVENTIONAL

Enrollment

723

Start Date

2025-08-06

Completion Date

2028-12-12

Last Updated

2026-03-23

Healthy Volunteers

Conditions

Type 1 Diabetes Mellitus

Interventions

DRUG

Teplizumab

Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion

OTHER

Placebo

Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion

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 oral, inhaled or systemically injected steroids 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, * 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.

Locations (124)

Scottsdale Clinical Trials- Site Number : 8400044

Scottsdale, Arizona, United States

Marvel Clinical Research- Site Number : 8400042

Huntington Beach, 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

University of South Florida- Site Number : 8400013

Tampa, Florida, United States

Atlanta Diabetes Associates- Site Number : 8400036

Atlanta, Georgia, United States

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

Columbus, Georgia, United States

Institute of Endocrinology Diabetes, Health & Hormones- Site Number : 8400050

Stockbridge, 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

Mayo Clinic in Rochester - Minnesota- Site Number : 8400019

Rochester, 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

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

Philadelphia, Pennsylvania, United States

AM Diabetes & Endocrinology Center- Site Number : 8400004

Bartlett, Tennessee, United States

Benaroya Research Institute at Virginia Mason- Site Number : 8400038

Seattle, Washington, United States

Mary Bridge Children's Outpatient Center- Site Number : 8400037

Tacoma, Washington, United States

Investigational Site Number : 0320005

Buenos Aires, Argentina

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 Israelita Albert Einstein- Site Number : 0760001

São Paulo, Brazil

Investigational Site Number : 1240002

Halifax, Nova Scotia, Canada

Investigational Site Number : 1560050

Pingxiang, Colorado, China

Investigational Site Number : 1560016

Luoyang, New Jersey, 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 : 1560018

Nanchang, China

Investigational Site Number : 1560043

Nanchang, China

Investigational Site Number : 1560005

Nanjing, China

Investigational Site Number : 1560054

Nanjing, China

Investigational Site Number : 1560031

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 : 1560027

Zhenjiang, China

Investigational Site Number : 2030004

Prague, Czechia

Investigational Site Number : 2030003

Prague, Czechia

Investigational Site Number : 2030001

Prague, Czechia

Investigational Site Number : 2500002

Paris, France

Investigational Site Number : 2500009

Paris, France

Investigational Site Number : 2500008

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 : 2760005

Hanover, Germany

Investigational Site Number : 2760010

Munich, Germany

Investigational Site Number : 2760001

Ulm, Germany

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

Azienda Ospedaliera Universitaria Meyer IRCCS - Site Number : 3800001

Florence, Firenze, Italy

IRCCS Istituto Giannina Gaslini - 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 : 3800010

Turin, Torino, Italy

AOU Maggiore della Carità - Site Number : 3800015

Novara, Italy

Investigational Site Number : 3800002

Verona, Italy

Investigational Site Number : 5280002

Leiden, Netherlands

Investigational Site Number : 5280001

Rotterdam, Netherlands

Investigational Site Number : 6160005

Lodz, Lódzkie, Poland

Investigational Site Number : 6160001

Warsaw, Masovian Voivodeship, Poland

Investigational Site Number : 7240012

Santiago de Compostela, A Coruña [La Coruña], Spain

Investigational Site Number : 7240017

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240003

Sabadell, Barcelona [Barcelona], Spain

Investigational Site Number : 7240020

Barakaldo, Basque Country, Spain

Investigational Site Number : 7240023

Alcalá de Henares, Madrid, Spain

Investigational Site Number : 7240016

Pamplona, Navarre, Spain

Investigational Site Number : 7240014

Pontevedra, 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 : 7240001

Seville, Sevilla, Spain

Investigational Site Number : 7240009

Madrid, Spain

Investigational Site Number : 7240011

Madrid, Spain

Investigational Site Number : 7240007

Madrid, Spain

Investigational Site Number : 7240022

Málaga, Spain

Investigational Site Number : 7240015

Palma, Spain

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (124)