Actively Recruiting
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)
Led by Sanofi · Updated on 2026-06-08
723
Participants Needed
159
Research Sites
27 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of teplizumab compared with a placebo in children and young adults aged 1 to 25 years who have been recently diagnosed with Stage 3 type 1 diabetes (T1D). This Phase 3, randomized, double-blind study aims to assess changes in blood sugar control and the need for mealtime insulin over a period of 52 weeks. Participants are receiving standard insulin therapy alongside the study treatments. Participants will be randomly assigned to receive either teplizumab or a placebo, both given through intravenous (IV) infusions. Teplizumab doses will be gradually increased, while the placebo group will receive matching infusions without the active drug. The overall study duration for each participant is about 84 weeks (18 months), allowing time for treatment and follow-up assessments. During the study, participants will undergo regular evaluations including blood tests to measure glycated hemoglobin (HbA1c), C-peptide levels, and glucose monitoring to assess blood sugar control. Researchers will also track days without needing mealtime insulin and monitor any side effects or adverse events. The study includes safety monitoring through laboratory tests and clinical assessments throughout the treatment and follow-up periods.
CONDITIONS
Brief 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, Insulin, or ICAs)
- 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
- Lactating women must stop breastfeeding and discard breast milk during and for 20 days after last study drug administration
- Capable of giving signed informed consent or have a legal representative sign if a minor
You will not qualify if you...
- Having diabetes types other than autoimmune type 1 diabetes, including genetic forms, MODY, secondary diabetes, or type 2 diabetes
- Active serious infection or fever above 38.56C within 48 hours before first dose (except localized skin infections)
- Acute or active infection with Epstein-Barr virus or cytomegalovirus
- Positive for HIV, hepatitis B, or hepatitis C
- Evidence of active or latent tuberculosis
- Other autoimmune diseases except stable autoimmune thyroid disease or controlled celiac disease
- Significant abnormal medical history or lab results that would affect safety or study assessments
- Recent or planned live vaccines within 8 weeks before first dose or during treatment up to 26 weeks after last dose
- Recent or planned inactivated or mRNA vaccines within 2 weeks before first dose or up to 6 weeks after last dose
- Use of anti-hyperglycemic agents other than insulin within 30 days before screening
- Past or current treatments affecting immune status or glucose tolerance within specified timeframes
- Previous treatment with teplizumab or other anti-CD3 therapies
- Participation in another investigational study with interventions within 8 weeks before screening
- Abnormal lab values including low lymphocyte, neutrophil, platelet counts, low hemoglobin, or elevated liver enzymes above specified limits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 months
Participants receive teplizumab or placebo through intravenous infusions in increasing doses as part of the study treatment.
Multiple visits for drug administration and assessments during treatment
Duration - Up to 6 months after treatment
Participants are monitored for safety and efficacy after completing treatment.
Additional visits for monitoring adverse events and outcomes
Trial Site Locations
Total: 159 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
Actively Recruiting
3
University of California San Francisco - Mission Bay- Site Number : 8400011
San Francisco, California, United States, 94158
Actively Recruiting
4
Barbara Davis Center for Childhood Diabetes- Site Number : 8400031
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Yale University School of Medicine- Site Number : 8400005
New Haven, Connecticut, United States, 06510
Actively Recruiting
6
University of Florida College of Medicine- Site Number : 8400054
Gainesville, Florida, United States, 32610
Actively Recruiting
7
Encore Medical Research - Hollywood- Site Number : 8400061
Hollywood, Florida, United States, 33024
Actively Recruiting
8
University of South Florida- Site Number : 8400013
Tampa, Florida, United States, 33612
Actively Recruiting
9
AdventHealth Winter Park- Site Number : 8400033
Winter Park, Florida, United States, 32792
Actively Recruiting
10
Atlanta Diabetes Associates- Site Number : 8400036
Atlanta, Georgia, United States, 30318
Actively Recruiting
11
IACT Health - Columbus - Talbotton Road- Site Number : 8400003
Columbus, Georgia, United States, 31904
Actively Recruiting
12
Institute of Endocrinology Diabetes, Health & Hormones- Site Number : 8400050
Stockbridge, Georgia, United States, 30281
Actively Recruiting
13
St. Luke's Children's Hospital- Site Number : 8400014
Boise, Idaho, United States, 83712
Actively Recruiting
14
Rocky Mountain Clinical Research - Idaho Falls- Site Number : 8400001
Idaho Falls, Idaho, United States, 83404
Actively Recruiting
15
Norton Children's Research Institute - Wendy Novak Diabetes Institute- Site Number : 8400016
Louisville, Kentucky, United States, 40202
Actively Recruiting
16
C.S. Mott Children's Hospital- Site Number : 8400015
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
17
Mayo Clinic in Rochester - Minnesota- Site Number : 8400019
Rochester, Minnesota, United States, 55905
Actively Recruiting
18
Park Nicollet Institute - Oncology Research- Site Number : 8400059
Saint Louis Park, Minnesota, United States, 55426
Actively Recruiting
19
Children's Mercy Adelle Hall Campus- Site Number : 8400010
Kansas City, Missouri, United States, 64108
Actively Recruiting
20
University At Buffalo - Jacobs School Of Medicine- Site Number : 8400006
Buffalo, New York, United States, 14203
Actively Recruiting
21
Endocrine Associates of West Village- Site Number : 8400064
New York, New York, United States, 10001
Actively Recruiting
22
Columbia University Irving Medical Center- Site Number : 8400009
New York, New York, United States, 10032
Actively Recruiting
23
Asheville Clinical Research- Site Number : 8400045
Asheville, North Carolina, United States, 28803
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24
Cincinnati Children's Hospital Medical Center- Site Number : 8400018
Cincinnati, Ohio, United States, 45229
Actively Recruiting
25
The Ohio State University- Site Number : 8400051
Columbus, Ohio, United States, 43210
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26
The Children's Hospital of Philadelphia- Site Number : 8400039
Philadelphia, Pennsylvania, United States, 19104
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27
AM Diabetes & Endocrinology Center- Site Number : 8400004
Bartlett, Tennessee, United States, 38133
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28
Vanderbilt University Medical Center- Site Number : 8400020
Nashville, Tennessee, United States, 37232
Actively Recruiting
29
Baylor College of Medicine- Site Number : 8400057
Houston, Texas, United States, 77030
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30
UVA Children's Battle Building- Site Number : 8400060
Charlottesville, Virginia, United States, 22903
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31
Benaroya Research Institute at Virginia Mason- Site Number : 8400038
Seattle, Washington, United States, 98101
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32
MultiCare Mary Bridge Children's Health Center- Site Number : 8400037
Tacoma, Washington, United States, 98405
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33
Investigational Site Number : 0320008
Mar del Plata, Buenos Aires, Argentina, 7600
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34
Investigational Site Number : 0320003
San Miguel de Tucumán, Tucumán Province, Argentina, 4000
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35
Investigational Site Number : 0320005
Buenos Aires, Argentina, 1419
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36
Investigational Site Number : 0320012
Santa Fe, Argentina, 3000
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37
Investigational Site Number : 0360001
Brisbane, Queensland, Australia, 4101
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38
Investigational Site Number : 0360003
Adelaide, South Australia, Australia, 5006
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39
Investigational Site Number : 0560005
Brussels, Belgium, 1020
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40
Investigational Site Number : 0560009
Brussels, Belgium, 1070
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41
Investigational Site Number : 0560007
Edegem, Belgium, 2650
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42
Investigational Site Number : 0560002
Jette, Belgium, 1090
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43
Investigational Site Number : 0560001
Leuven, Belgium, 3000
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44
Investigational Site Number : 0560008
Leuven, Belgium, 3000
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45
Investigational Site Number : 0560006
Liège, Belgium, 4000
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46
Investigational Site Number : 0560004
Namur, Belgium, 5000
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47
Hospital Universitario Walter Cantidio- Site Number : 0760009
Fortaleza, Ceará, Brazil, 60430-270
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48
Centro de Diabetes Curitiba- Site Number : 0760006
Curitiba, Paraná, Brazil, 80810-040
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49
Centro de Pesquisa Clínica de Marília - CPCLIM- Site Number : 0760002
Marília, São Paulo, Brazil, 17504-072
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50
Hospital Universitario Clementino Fraga Filho- Site Number : 0760008
Rio de Janeiro, Brazil, 21941-913
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51
Centro de Pesquisas Clínicas - São Paulo- Site Number : 0760011
São Paulo, Brazil, 01228-200
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52
Hospital Israelita Albert Einstein- Site Number : 0760001
São Paulo, Brazil, 05651-901
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53
Investigational Site Number : 1240002
Halifax, Nova Scotia, Canada, B3H 2Y9
Actively Recruiting
54
Investigational Site Number : 1560050
Pingxiang, Colorado, China, 337055
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55
Investigational Site Number : 1560016
Luoyang, New Jersey, China, 471003
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56
Investigational Site Number : 1560035
Beijing, China, 100020
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57
Investigational Site Number : 1560003
Beijing, China, 100034
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58
Investigational Site Number : 1560033
Beijing, China, 100045
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59
Investigational Site Number : 1560009
Changchun, China, 130041
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60
Investigational Site Number : 1560001
Changsha, China, 410011
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61
Investigational Site Number : 1560055
Chengdu, China, 610072
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62
Investigational Site Number : 1560042
Chengdu, China, 610091
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63
Investigational Site Number : 1560007
Guangzhou, China, 510120
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64
Investigational Site Number : 1560037
Guangzhou, China, 510620
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65
Investigational Site Number : 1560040
Hangzhou, China, 310003
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66
Investigational Site Number : 1560014
Hangzhou, China, 310009
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67
Investigational Site Number : 1560012
Hangzhou, China, 310014
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68
Investigational Site Number : 1560010
Harbin, China, 150001
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69
Investigational Site Number : 1560026
Hohhot, China, 010050
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70
Investigational Site Number : 1560059
Jinan, China, 250001
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71
Investigational Site Number : 1560056
Lanzhou, China, 730000
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72
Investigational Site Number : 1560018
Nanchang, China, 330006
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73
Investigational Site Number : 1560043
Nanchang, China, 330038
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74
Investigational Site Number : 1560005
Nanjing, China, 210008
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75
Investigational Site Number : 1560034
Nanjing, China, 210008
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76
Investigational Site Number : 1560054
Nanjing, China, 210029
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77
Investigational Site Number : 1560031
Shanghai, China, 200032
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78
Investigational Site Number : 1560032
Shanghai, China, 200040
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79
Investigational Site Number : 1560013
Shenyang, China, 110004
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80
Investigational Site Number : 1560045
Shenzhen, China, 518026
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81
Investigational Site Number : 1560019
Tianjin, China, 300052
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82
Investigational Site Number : 1560039
Wuhan, China, 430010
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83
Investigational Site Number : 1560002
Wuhan, China, 430030
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84
Investigational Site Number : 1560041
Wuxi, China, 214023
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85
Investigational Site Number : 1560060
Yueyang, China, 414000
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86
Investigational Site Number : 1560038
Zhengzhou, China, 450018
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87
Investigational Site Number : 1560027
Zhenjiang, China, 212000
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88
Investigational Site Number : 2030004
Prague, Czechia, 128 08
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89
Investigational Site Number : 2030003
Prague, Czechia, 140 21
Actively Recruiting
90
Investigational Site Number : 2030001
Prague, Czechia, 150 06
Actively Recruiting
91
Investigational Site Number : 2500010
La Tronche, France, 38700
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92
Investigational Site Number : 2500002
Paris, France, 75010
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93
Investigational Site Number : 2500008
Paris, France, 75013
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94
Investigational Site Number : 2500009
Paris, France, 75019
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95
Investigational Site Number : 2500005
Pau, France, 64000
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96
Investigational Site Number : 2500007
Strasbourg, France, 67000
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97
Investigational Site Number : 2760002
Augsburg, Germany, 86156
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98
Investigational Site Number : 2760008
Bielefeld, Germany, 33617
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99
Investigational Site Number : 2760005
Hanover, Germany, 30173
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100
Investigational Site Number : 2760006
Leipzig, Germany, 04103
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101
Investigational Site Number : 2760010
Munich, Germany, 81675
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102
Investigational Site Number : 2760001
Ulm, Germany, 89081
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103
Investigational Site Number : 3760005
Jerusalem, Israel, 9112001
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104
Investigational Site Number : 3760002
Petah Tikva, Israel, 4920235
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105
Investigational Site Number : 3760003
Petah Tikva, Israel, 4941492
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106
Investigational Site Number : 3760001
Ramat Gan, Israel, 5262100
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107
Investigational Site Number : 3760006
Rehovot, Israel, 7610001
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108
Investigational Site Number : 3760004
Tel Aviv, Israel, 6423906
Actively Recruiting
109
Azienda Ospedaliera Universitaria Meyer IRCCS - Site Number : 3800001
Florence, Firenze, Italy, 50139
Actively Recruiting
110
IRCCS Istituto Giannina Gaslini - Site Number : 3800008
Genoa, Genova, Italy, 16147
Actively Recruiting
111
Ospedale dei Bambini Vittore Buzzi - Site Number : 3800005
Milan, Milano, Italy, 20154
Actively Recruiting
112
Investigational Site Number : 3800011
Milan, Milano, Italy, 20157
Actively Recruiting
113
AOU Policlinico Umberto I, UOC Diabetologia -Site Number : 3800012
Rome, Roma, Italy, 00161
Actively Recruiting
114
Investigational Site Number : 3800003
Rome, Roma, Italy, 00165
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115
Investigational Site Number : 3800010
Turin, Torino, Italy, 10126
Actively Recruiting
116
Investigational Site Number : 3800014
Messina, Italy, 98125
Actively Recruiting
117
AOU Maggiore della Carità - Site Number : 3800015
Novara, Italy, 28100
Actively Recruiting
118
Azienda Ospedaliera Universitaria Integrata di Verona -Site Number : 3800002
Verona, Italy, 37126
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119
Investigational Site Number : 3920020
Nagoya, Aichi-ken, Japan, 453-8511
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120
Investigational Site Number : 3920007
Koshigaya, Saitama, Japan, 343-0845
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121
Investigational Site Number : 3920015
Kyoto, Japan, 606-8507
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122
Investigational Site Number : 3920017
Nara, Japan, 630-8581
Actively Recruiting
123
Investigational Site Number : 3920006
Niigata, Japan, 951-8520
Actively Recruiting
124
Investigational Site Number : 3920013
Tokyo, Japan, 101-8309
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125
Investigational Site Number : 5280003
Amersfoort, Netherlands, 3813 TZ
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126
Investigational Site Number : 5280002
Leiden, Netherlands, 2333 ZA
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127
Investigational Site Number : 5280001
Rotterdam, Netherlands, 3011 TA
Actively Recruiting
128
Investigational Site Number : 6160005
Lodz, Lódzkie, Poland, 92-213
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129
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship, Poland, 02-117
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130
Investigational Site Number : 6160006
Bialystok, Poland, 15-274
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131
Investigational Site Number : 7240012
Santiago de Compostela, A Coruña [La Coruña], Spain, 15706
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132
Investigational Site Number : 7240017
Barcelona, Barcelona [Barcelona], Spain, 08035
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133
Investigational Site Number : 7240004
Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950
Actively Recruiting
134
Investigational Site Number : 7240003
Sabadell, Barcelona [Barcelona], Spain, 08208
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135
Investigational Site Number : 7240020
Barakaldo, Basque Country, Spain, 48903
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136
Investigational Site Number : 7240023
Alcalá de Henares, Madrid, Spain, 28805
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137
Investigational Site Number : 7240016
Pamplona, Navarre, Spain, 31008
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138
Investigational Site Number : 7240014
Pontevedra, Pontevedra [Pontevedra], Spain, 36312
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139
Investigational Site Number : 7240019
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
Actively Recruiting
140
Investigational Site Number : 7240021
Seville, Sevilla, Spain, 41009
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141
Investigational Site Number : 7240001
Seville, Sevilla, Spain, 41013
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142
Investigational Site Number : 7240006
Madrid, Spain, 28007
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143
Investigational Site Number : 7240010
Madrid, Spain, 28009
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144
Investigational Site Number : 7240009
Madrid, Spain, 28034
Actively Recruiting
145
Investigational Site Number : 7240011
Madrid, Spain, 28040
Actively Recruiting
146
Investigational Site Number : 7240007
Madrid, Spain, 28046
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147
Investigational Site Number : 7240022
Málaga, Spain, 29010
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148
Investigational Site Number : 7240015
Palma, Spain, 07120
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149
Investigational Site Number : 8260001
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
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150
Investigational Site Number : 8260004
Dundee, Dundee City, United Kingdom, DD1 9SY
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151
Investigational Site Number : 8260009
London, England, United Kingdom, E1 1BB
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152
Investigational Site Number : 8260012
London, England, United Kingdom, SW10 9NH
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153
Investigational Site Number : 8260002
Glasgow, Glasgow City, United Kingdom, G51 4TF
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154
Investigational Site Number : 8260007
London, London, City of, United Kingdom, SE5 9RL
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155
Investigational Site Number : 8260011
Bath, Somerset, United Kingdom, BA1 3NG
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156
Investigational Site Number : 8260006
Guildford, Surrey, United Kingdom, GU2 7XX
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157
Investigational Site Number : 8260005
Leeds, United Kingdom, LS9 7TF
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158
Investigational Site Number : 8260010
Reading, United Kingdom, RG1 5AN
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159
Investigational Site Number : 8260003
Sheffield, United Kingdom, S10 2TH
Actively Recruiting
Research Team
T
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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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