RecruitingPhase 3NCT07088068

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

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)

Sponsor

Sanofi

Enrollment

723 participants

Start Date

Aug 6, 2025

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes Mellitus

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.

Eligibility

Min Age: 1 YearMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether teplizumab (an immune-modifying drug) can slow or stop the immune system from continuing to destroy insulin-producing cells in people who have recently been diagnosed with Type 1 diabetes (Stage 3). Participants aged 1 to 25 are eligible. **You may be eligible if...** - You are between 1 and 25 years old - You have a confirmed Stage 3 Type 1 diabetes diagnosis (meaning you already have symptoms and elevated blood sugar) - You have been diagnosed within the past 6 weeks - You still have some remaining insulin-producing ability **You may NOT be eligible if...** - You have a history of serious infections or immune disorders - You have received prior treatment with teplizumab - You are pregnant or breastfeeding - You have other significant medical conditions that could affect safety Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTeplizumab

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

OTHERPlacebo

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

Locations(141)

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

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

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 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

Vanderbilt University Medical Center- Site Number : 8400020

Nashville, Tennessee, 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

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

Tacoma, Washington, United States

Investigational Site Number : 0320003

San Miguel de Tucumán, Tucumán Province, Argentina

Investigational Site Number : 0320005

Buenos Aires, Argentina

Investigational Site Number : 0360001

Brisbane, Queensland, 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 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 : 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 : 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 : 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 : 2500002

Paris, France

Investigational Site Number : 2500008

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 : 2760005

Hanover, Germany

Investigational Site Number : 2760006

Leipzig, 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

Ospedale dei Bambini Vittore Buzzi - Site Number : 3800005

Milan, Milano, Italy

Investigational Site Number : 3800011

Milan, Milano, Italy

AOU Policlinico Umberto I, UOC Diabetologia -Site Number : 3800012

Rome, Roma, Italy

Investigational Site Number : 3800003

Rome, Roma, Italy

Investigational Site Number : 3800010

Turin, Torino, Italy

Investigational Site Number : 3800014

Messina, Italy

AOU Maggiore della Carità - Site Number : 3800015

Novara, Italy

Azienda Ospedaliera Universitaria Integrata di Verona -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 : 7240004

Esplugues de Llobregat, 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 : 7240006

Madrid, Spain

Investigational Site Number : 7240010

Madrid, 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

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NCT07088068

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