Actively Recruiting
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
Led by Sanofi · Updated on 2026-04-23
723
Participants Needed
141
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be between 1 and 25 years old at the time of consent
- Diagnosed with Stage 3 type 1 diabetes according to American Diabetes Association 2025 criteria
- Able to start study drug within 8 weeks (56 days) of Stage 3 T1D diagnosis
- Positive for at least one type 1 diabetes autoantibody (GAD-65, IA-2, ZnT8, or Insulin within 14 days of starting insulin therapy)
- Random C-peptide level of at least 0.2 nmol/L at screening
- Both male and female participants are eligible
- Women of childbearing potential must use highly effective contraception and have a negative pregnancy test before treatment
- Lactating women must stop breastfeeding and discard milk during and for 20 days after treatment
- Capable of providing signed informed consent, with legal guardian consent if underage
You will not qualify if you...
- Diabetes types other than autoimmune type 1 diabetes (eg, genetic diabetes, MODY, type 2 diabetes)
- Active serious infection or fever over 38.5°C within 48 hours before first dose (except localized skin infection)
- Active or recent infection with Epstein-Barr virus or cytomegalovirus
- Positive test for HIV, hepatitis B, or hepatitis C
- Active or latent tuberculosis
- Other autoimmune diseases except stable autoimmune thyroid disease or controlled celiac disease
- Significant medical abnormalities or adverse events that affect safety or study assessment
- Recent or planned vaccinations with live vaccines within 8 weeks before treatment or during study up to 26 weeks after last dose
- Recent or planned inactivated or mRNA vaccines within 2 weeks before treatment or during study up to 6 weeks after last dose
- Use of anti-hyperglycemic agents other than insulin within 30 days before screening
- Use of medications affecting immune status or glucose tolerance within defined periods before screening
- Previous treatment with teplizumab or anti-CD3 therapies
- Participation in another investigational study with treatment within 8 weeks before screening
- Laboratory abnormalities including low lymphocyte, neutrophil, platelet counts, low hemoglobin, or elevated liver enzymes beyond specified limits
- Total bilirubin above 1.5 times upper limit of normal except for Gilbert's syndrome without other causes of high bilirubin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 141 locations
1
Scottsdale Clinical Trials- Site Number : 8400044
Scottsdale, Arizona, United States, 85260
Actively Recruiting
2
Marvel Clinical Research- Site Number : 8400042
Huntington Beach, California, United States, 92647
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3
University of California San Francisco - Mission Bay- Site Number : 8400011
San Francisco, California, United States, 94158
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4
Barbara Davis Center for Childhood Diabetes- Site Number : 8400031
Aurora, Colorado, United States, 80045
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5
Yale University School of Medicine- Site Number : 8400005
New Haven, Connecticut, United States, 06510
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6
University of Florida College of Medicine- Site Number : 8400054
Gainesville, Florida, United States, 32610
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7
Encore Medical Research - Hollywood- Site Number : 8400061
Hollywood, Florida, United States, 33024
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8
University of South Florida- Site Number : 8400013
Tampa, Florida, United States, 33612
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9
Atlanta Diabetes Associates- Site Number : 8400036
Atlanta, Georgia, United States, 30318
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10
IACT Health - Columbus - Talbotton Road- Site Number : 8400003
Columbus, Georgia, United States, 31904
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11
Institute of Endocrinology Diabetes, Health & Hormones- Site Number : 8400050
Stockbridge, Georgia, United States, 30281
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12
St. Luke's Children's Hospital- Site Number : 8400014
Boise, Idaho, United States, 83712
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13
Rocky Mountain Clinical Research - Idaho Falls- Site Number : 8400001
Idaho Falls, Idaho, United States, 83404
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14
C.S. Mott Children's Hospital- Site Number : 8400015
Ann Arbor, Michigan, United States, 48109
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15
Mayo Clinic in Rochester - Minnesota- Site Number : 8400019
Rochester, Minnesota, United States, 55905
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16
Children's Mercy Adelle Hall Campus- Site Number : 8400010
Kansas City, Missouri, United States, 64108
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17
University At Buffalo - Jacobs School Of Medicine- Site Number : 8400006
Buffalo, New York, United States, 14203
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18
Endocrine Associates of West Village- Site Number : 8400064
New York, New York, United States, 10001
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19
Columbia University Irving Medical Center- Site Number : 8400009
New York, New York, United States, 10032
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20
Asheville Clinical Research- Site Number : 8400045
Asheville, North Carolina, United States, 28803
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21
The Ohio State University- Site Number : 8400051
Columbus, Ohio, United States, 43210
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22
The Children's Hospital of Philadelphia- Site Number : 8400039
Philadelphia, Pennsylvania, United States, 19104
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23
AM Diabetes & Endocrinology Center- Site Number : 8400004
Bartlett, Tennessee, United States, 38133
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24
Vanderbilt University Medical Center- Site Number : 8400020
Nashville, Tennessee, United States, 37232
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25
UVA Children's Battle Building- Site Number : 8400060
Charlottesville, Virginia, United States, 22903
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26
Benaroya Research Institute at Virginia Mason- Site Number : 8400038
Seattle, Washington, United States, 98101
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27
Mary Bridge Children's Outpatient Center- Site Number : 8400037
Tacoma, Washington, United States, 98405
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28
Investigational Site Number : 0320003
San Miguel de Tucumán, Tucumán Province, Argentina, 4000
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29
Investigational Site Number : 0320005
Buenos Aires, Argentina, 1419
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30
Investigational Site Number : 0360001
Brisbane, Queensland, Australia, 4101
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31
Investigational Site Number : 0560005
Brussels, Belgium, 1020
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32
Investigational Site Number : 0560009
Brussels, Belgium, 1070
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33
Investigational Site Number : 0560007
Edegem, Belgium, 2650
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34
Investigational Site Number : 0560002
Jette, Belgium, 1090
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35
Investigational Site Number : 0560001
Leuven, Belgium, 3000
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36
Investigational Site Number : 0560008
Leuven, Belgium, 3000
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37
Investigational Site Number : 0560006
Liège, Belgium, 4000
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38
Investigational Site Number : 0560004
Namur, Belgium, 5000
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39
Hospital Universitario Walter Cantidio- Site Number : 0760009
Fortaleza, Ceará, Brazil, 60430-270
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40
Centro de Diabetes Curitiba- Site Number : 0760006
Curitiba, Paraná, Brazil, 80810-040
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41
Centro de Pesquisa Clínica de Marília - CPCLIM- Site Number : 0760002
Marília, São Paulo, Brazil, 17504-072
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42
Hospital Universitario Clementino Fraga Filho- Site Number : 0760008
Rio de Janeiro, Brazil, 21941-913
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43
Centro de Pesquisas Clínicas - São Paulo- Site Number : 0760011
São Paulo, Brazil, 01228-200
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44
Hospital Israelita Albert Einstein- Site Number : 0760001
São Paulo, Brazil, 05651-901
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45
Investigational Site Number : 1240002
Halifax, Nova Scotia, Canada, B3H 2Y9
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46
Investigational Site Number : 1560050
Pingxiang, Colorado, China, 337055
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47
Investigational Site Number : 1560016
Luoyang, New Jersey, China, 471003
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48
Investigational Site Number : 1560035
Beijing, China, 100020
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49
Investigational Site Number : 1560003
Beijing, China, 100034
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50
Investigational Site Number : 1560033
Beijing, China, 100045
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51
Investigational Site Number : 1560009
Changchun, China, 130041
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52
Investigational Site Number : 1560001
Changsha, China, 410011
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53
Investigational Site Number : 1560055
Chengdu, China, 610072
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54
Investigational Site Number : 1560042
Chengdu, China, 610091
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55
Investigational Site Number : 1560007
Guangzhou, China, 510120
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56
Investigational Site Number : 1560037
Guangzhou, China, 510620
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57
Investigational Site Number : 1560040
Hangzhou, China, 310003
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58
Investigational Site Number : 1560014
Hangzhou, China, 310009
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59
Investigational Site Number : 1560012
Hangzhou, China, 310014
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60
Investigational Site Number : 1560010
Harbin, China, 150001
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61
Investigational Site Number : 1560026
Hohhot, China, 010050
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62
Investigational Site Number : 1560059
Jinan, China, 250001
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63
Investigational Site Number : 1560056
Lanzhou, China, 730000
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64
Investigational Site Number : 1560018
Nanchang, China, 330006
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65
Investigational Site Number : 1560043
Nanchang, China, 330038
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66
Investigational Site Number : 1560005
Nanjing, China, 210008
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67
Investigational Site Number : 1560034
Nanjing, China, 210008
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68
Investigational Site Number : 1560054
Nanjing, China, 210029
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69
Investigational Site Number : 1560031
Shanghai, China, 200032
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70
Investigational Site Number : 1560032
Shanghai, China, 200040
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71
Investigational Site Number : 1560013
Shenyang, China, 110004
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72
Investigational Site Number : 1560045
Shenzhen, China, 518026
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73
Investigational Site Number : 1560019
Tianjin, China, 300052
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74
Investigational Site Number : 1560039
Wuhan, China, 430010
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75
Investigational Site Number : 1560002
Wuhan, China, 430030
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76
Investigational Site Number : 1560041
Wuxi, China, 214023
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77
Investigational Site Number : 1560060
Yueyang, China, 414000
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78
Investigational Site Number : 1560038
Zhengzhou, China, 450018
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79
Investigational Site Number : 1560027
Zhenjiang, China, 212000
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80
Investigational Site Number : 2030004
Prague, Czechia, 128 08
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81
Investigational Site Number : 2030003
Prague, Czechia, 140 21
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82
Investigational Site Number : 2030001
Prague, Czechia, 150 06
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83
Investigational Site Number : 2500002
Paris, France, 75010
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84
Investigational Site Number : 2500008
Paris, France, 75013
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85
Investigational Site Number : 2500009
Paris, France, 75019
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86
Investigational Site Number : 2500005
Pau, France, 64000
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87
Investigational Site Number : 2500007
Strasbourg, France, 67000
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88
Investigational Site Number : 2760002
Augsburg, Germany, 86156
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89
Investigational Site Number : 2760008
Bielefeld, Germany, 33617
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90
Investigational Site Number : 2760005
Hanover, Germany, 30173
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91
Investigational Site Number : 2760006
Leipzig, Germany, 04103
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92
Investigational Site Number : 2760010
Munich, Germany, 81675
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93
Investigational Site Number : 2760001
Ulm, Germany, 89081
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94
Investigational Site Number : 3760005
Jerusalem, Israel, 9112001
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95
Investigational Site Number : 3760002
Petah Tikva, Israel, 4920235
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96
Investigational Site Number : 3760003
Petah Tikva, Israel, 4941492
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97
Investigational Site Number : 3760001
Ramat Gan, Israel, 5262100
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98
Investigational Site Number : 3760006
Rehovot, Israel, 7610001
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99
Investigational Site Number : 3760004
Tel Aviv, Israel, 6423906
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100
Azienda Ospedaliera Universitaria Meyer IRCCS - Site Number : 3800001
Florence, Firenze, Italy, 50139
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101
IRCCS Istituto Giannina Gaslini - Site Number : 3800008
Genoa, Genova, Italy, 16147
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102
Ospedale dei Bambini Vittore Buzzi - Site Number : 3800005
Milan, Milano, Italy, 20154
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103
Investigational Site Number : 3800011
Milan, Milano, Italy, 20157
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104
AOU Policlinico Umberto I, UOC Diabetologia -Site Number : 3800012
Rome, Roma, Italy, 00161
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105
Investigational Site Number : 3800003
Rome, Roma, Italy, 00165
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106
Investigational Site Number : 3800010
Turin, Torino, Italy, 10126
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107
Investigational Site Number : 3800014
Messina, Italy, 98125
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108
AOU Maggiore della Carità - Site Number : 3800015
Novara, Italy, 28100
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109
Azienda Ospedaliera Universitaria Integrata di Verona -Site Number : 3800002
Verona, Italy, 37126
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110
Investigational Site Number : 5280002
Leiden, Netherlands, 2333 ZA
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111
Investigational Site Number : 5280001
Rotterdam, Netherlands, 3011 TA
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112
Investigational Site Number : 6160005
Lodz, Lódzkie, Poland, 92-213
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113
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship, Poland, 02-117
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114
Investigational Site Number : 7240012
Santiago de Compostela, A Coruña [La Coruña], Spain, 15706
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115
Investigational Site Number : 7240017
Barcelona, Barcelona [Barcelona], Spain, 08035
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116
Investigational Site Number : 7240004
Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950
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117
Investigational Site Number : 7240003
Sabadell, Barcelona [Barcelona], Spain, 08208
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118
Investigational Site Number : 7240020
Barakaldo, Basque Country, Spain, 48903
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119
Investigational Site Number : 7240023
Alcalá de Henares, Madrid, Spain, 28805
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120
Investigational Site Number : 7240016
Pamplona, Navarre, Spain, 31008
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121
Investigational Site Number : 7240014
Pontevedra, Pontevedra [Pontevedra], Spain, 36312
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122
Investigational Site Number : 7240019
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
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123
Investigational Site Number : 7240021
Seville, Sevilla, Spain, 41009
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124
Investigational Site Number : 7240001
Seville, Sevilla, Spain, 41013
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125
Investigational Site Number : 7240006
Madrid, Spain, 28007
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126
Investigational Site Number : 7240010
Madrid, Spain, 28009
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127
Investigational Site Number : 7240009
Madrid, Spain, 28034
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128
Investigational Site Number : 7240011
Madrid, Spain, 28040
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129
Investigational Site Number : 7240007
Madrid, Spain, 28046
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130
Investigational Site Number : 7240022
Málaga, Spain, 29010
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131
Investigational Site Number : 7240015
Palma, Spain, 07120
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132
Investigational Site Number : 8260001
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
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133
Investigational Site Number : 8260004
Dundee, Dundee City, United Kingdom, DD1 9SY
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134
Investigational Site Number : 8260009
London, England, United Kingdom, E1 1BB
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135
Investigational Site Number : 8260012
London, England, United Kingdom, SW10 9NH
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136
Investigational Site Number : 8260002
Glasgow, Glasgow City, United Kingdom, G51 4TF
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137
Investigational Site Number : 8260007
London, London, City of, United Kingdom, SE5 9RL
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138
Investigational Site Number : 8260011
Bath, Somerset, United Kingdom, BA1 3NG
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139
Investigational Site Number : 8260006
Guildford, Surrey, United Kingdom, GU2 7XX
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140
Investigational Site Number : 8260005
Leeds, United Kingdom, LS9 7TF
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141
Investigational Site Number : 8260010
Reading, United Kingdom, RG1 5AN
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Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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