Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab

PHASE3CompletedINTERVENTIONAL
Enrollment

328

Participants

Timeline

Start Date

April 5, 2019

Primary Completion Date

May 1, 2023

Study Completion Date

May 1, 2023

Conditions
Type 1 Diabetes Mellitus
Interventions
BIOLOGICAL

teplizumab

Treatment

BIOLOGICAL

Placebo

Control

Trial Locations (62)

1090

UZ Brussel - Campus Jette (Site 202), Brussels

5000

CHU UCL Namur, site Clinique Sainte-Elisabeth (Site 205), Namur

6200

Hopitaux Pediatriques de Nice CHU-Lenval service de diabetologie et d'endocrinologia (Site 508), Nice

9000

UZ Gent (Site 206), Ghent

13005

CHU Hopital de la Timone-Hopital d'Enfants (Site 512), Marseille

14203

Women and Children's Hospital of Buffalo (Site 010), Buffalo

19104

Childrens Hospital of Philadelphia - Endocrinology (Site 021), Philadelphia

20746

Capital Diabetes & Endocrine Associates (Site 029), Camp Springs

21079

CHU DIJON hopital d'enfant (Site 504), Dijon

27599

UNC Hospitals Children's Specialty Clinic (Site 038), Chapel Hill

30173

Kinderkrankenhaus Auf Der Bult (Site 604), Hanover

30318

Atlanta Diabetes Associates (Site 009), Atlanta

31904

Centricity Research (Site 006), Columbus

32207

Nemours Children's Specialty Care-Endocrinology (Site 047), Jacksonville

32610

UF Clinical and Translation Research Building (Site 015), Gainesville

33136

University of Miami Health System (Site 028), Miami

33612

University of South Florida Diabetes and Endocrinology Center (Site 011), Tampa

33617

Evangelisches Klinikum Bethel Kinderklinik (Site 602), Bielefeld

33701

All Children's Hospital-Johns Hopkins Medicine (Site 048), St. Petersburg

37232

Vanderbilt University Medical Center (Site 024), Nashville

38133

AM Diabetes & Endocrinology Center (Site 008), Bartlett

44106

Rainbow Babies & Children's Hospital (Site 049), Cleveland

44195

Cleveland Clinic (Site 051), Cleveland

45100

Centre Hospitalier Regional (CHR) d'Orleans-Service de pediatrie (Site 513), Orléans

46202

Indiana University Hospital and Riley Hospital for Children (Site 014), Indianapolis

52242

U. Iowa Children's Hospital (Site 023), Iowa City

55454

U. Minnesota Health Clinical Research Unit (Site 031), Minneapolis

57105

Sanford Diabetes and Thyroiid Clinical (Site 013), Sioux Falls

60637

University of Chicago Medical Center (Site 017), Chicago

63110

Washington University School of Medicine (Site 018), St Louis

64046

Centre hospitalier de Pau (Site 501), Pau

64108

Children's Mercy Hospitals & Clinics (Site 026), Kansas City

69120

Universitätsklinikum Heidelberg (Site 608), Heidelberg

69677

Groupe hospitalier Est-Hopital Femme, Mere, Enfant (Site 509), Bron

75015

Groupe Hospitalier Necker Enfants Malades (site 502), Paris

75235

Children's Medical Center Dallas (Site 033), Dallas

79106

Universitätsklinikum Freiburg (Site 603), Freiburg im Breisgau

80045

University of Colorado-Barbara Davis Center for Childhood Diabetes (Site 005), Aurora

82712

St. Luke's Children's Endocrinology (Site 052), Boise

83404

Rocky Mountain Diabetes and Osteoporosis Center (Site 007), Idaho Falls

86156

Universitätsklinikum Augsburg (Site 606), Augsburg

92123

Rady Children's Hospital-San Diego (Site 004), San Diego

94158

UCSF Medical Center (Site 001), San Francisco

94598

Diablo Clinical Research, Inc. (Site 002), Walnut Creek

97702

Endocrinology Service Northwest, LLC (Site 034), Bend

98101

Benaroya Research Institute at Virginia Mason (Site 016), Seattle

98405

MultiCare Institute for Research & Innovation (Site 003), Tacoma

06520

Yale University of Medicine (Site 020), New Haven

01199

Baystate Pediatric Endocrinology & Diabetes (Site 040), Springfield

T6G 2J3

Alberta Diabetes Institute Clinical Research Unit Li Ka Shing Centre for Health Research Innovation (Site 103), Edmonton

Unknown

BC Diabetes (Site 102), Vancouver

Montreal Children's Hospital-McGill (Site 101), Montreal

Békés Megyei Központi Kórház Pándy Kálmán Tagkórház ( Site 705), Gyula

150 06

Fakultni nemocnice v Motole (Site 301), Prague

-1307

Universitatsklinikum Carl Gustav Carus (Site 601), Dresden

01-184

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu (Site 804), Warsaw

02-117

Instytut Diabetologii Sp. z o.o. (Site 802), Warsaw

04-730

"Instytut Pomnik - Centrum Zdrowia Dziecka (Site 801)", Warsaw

80-952

Uniwersyteckie Centrum Kliniczne (Site 803), Warsaw

HA1 3UJ

Northwick Park Hospital - Paediatrics (site 904), London

CF14 4XN

Cardiff and Vale NHS Trust - University Hospital of Wales (Site 902), Cardiff

s10 2TH

Sheffield Children's NHS Foundation Trust Western Bank (Site 903), Sheffield

All Listed Sponsors
lead

Provention Bio, Inc.

INDUSTRY

NCT03875729 - Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab | Biotech Hunter | Biotech Hunter