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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
teplizumab
Placebo
Sponsored by
Provention Bio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring T1D, type 1 diabetes, recent-onset T1D

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Is 8 to 17 years of age, inclusive, at the time of randomization/initiation of study drug administration.
  2. Has received a diagnosis of T1D according to the criteria from the American Diabetes Association.
  3. Is able to be randomized and initiate study drug within 6 weeks (42 days) of the formal T1D diagnosis.
  4. Has a peak stimulated C-peptide of ≥0.2 pmol/mL from a mixed meal tolerance test (MMTT) at screening.
  5. Has a positive result on testing for T1D-related autoantibodies.

Exclusion Criteria:

  1. Has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease.
  2. Has an active infection and/or fever.
  3. Has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
  4. An individual who has a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.

Sites / Locations

  • Rady Children's Hospital-San Diego (Site 004)
  • UCSF Medical Center (Site 001)
  • Diablo Clinical Research, Inc. (Site 002)
  • University of Colorado-Barbara Davis Center for Childhood Diabetes (Site 005)
  • Yale University of Medicine (Site 020)
  • UF Clinical and Translation Research Building (Site 015)
  • Nemours Children's Specialty Care-Endocrinology (Site 047)
  • University of Miami Health System (Site 028)
  • All Children's Hospital-Johns Hopkins Medicine (Site 048)
  • University of South Florida Diabetes and Endocrinology Center (Site 011)
  • Atlanta Diabetes Associates (Site 009)
  • Centricity Research (Site 006)
  • St. Luke's Children's Endocrinology (Site 052)
  • Rocky Mountain Diabetes and Osteoporosis Center (Site 007)
  • University of Chicago Medical Center (Site 017)
  • Indiana University Hospital and Riley Hospital for Children (Site 014)
  • U. Iowa Children's Hospital (Site 023)
  • Capital Diabetes & Endocrine Associates (Site 029)
  • Baystate Pediatric Endocrinology & Diabetes (Site 040)
  • U. Minnesota Health Clinical Research Unit (Site 031)
  • Children's Mercy Hospitals & Clinics (Site 026)
  • Washington University School of Medicine (Site 018)
  • Women and Children's Hospital of Buffalo (Site 010)
  • UNC Hospitals Children's Specialty Clinic (Site 038)
  • Rainbow Babies & Children's Hospital (Site 049)
  • Cleveland Clinic (Site 051)
  • Endocrinology Service Northwest, LLC (Site 034)
  • Childrens Hospital of Philadelphia - Endocrinology (Site 021)
  • Sanford Diabetes and Thyroiid Clinical (Site 013)
  • AM Diabetes & Endocrinology Center (Site 008)
  • Vanderbilt University Medical Center (Site 024)
  • Children's Medical Center Dallas (Site 033)
  • Benaroya Research Institute at Virginia Mason (Site 016)
  • MultiCare Institute for Research & Innovation (Site 003)
  • UZ Brussel - Campus Jette (Site 202)
  • UZ Gent (Site 206)
  • CHU UCL Namur, site Clinique Sainte-Elisabeth (Site 205)
  • Alberta Diabetes Institute Clinical Research Unit Li Ka Shing Centre for Health Research Innovation (Site 103)
  • BC Diabetes (Site 102)
  • Montreal Children's Hospital-McGill (Site 101)
  • Fakultni nemocnice v Motole (Site 301)
  • Hopitaux Pediatriques de Nice CHU-Lenval service de diabetologie et d'endocrinologia (Site 508)
  • CHU Hopital de la Timone-Hopital d'Enfants (Site 512)
  • CHU DIJON hopital d'enfant (Site 504)
  • Groupe Hospitalier Necker Enfants Malades (site 502)
  • Centre Hospitalier Regional (CHR) d'Orleans-Service de pediatrie (Site 513)
  • Groupe hospitalier Est-Hopital Femme, Mere, Enfant (Site 509)
  • Centre hospitalier de Pau (Site 501)
  • Universitätsklinikum Freiburg (Site 603)
  • Universitätsklinikum Heidelberg (Site 608)
  • Universitätsklinikum Augsburg (Site 606)
  • Evangelisches Klinikum Bethel Kinderklinik (Site 602)
  • Universitatsklinikum Carl Gustav Carus (Site 601)
  • Kinderkrankenhaus Auf Der Bult (Site 604)
  • Békés Megyei Központi Kórház Pándy Kálmán Tagkórház ( Site 705)
  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu (Site 804)
  • Instytut Diabetologii Sp. z o.o. (Site 802)
  • Instytut "Pomnik - Centrum Zdrowia Dziecka" (Site 801)
  • Uniwersyteckie Centrum Kliniczne (Site 803)
  • Northwick Park Hospital - Paediatrics (site 904)
  • Cardiff and Vale NHS Trust - University Hospital of Wales (Site 902)
  • Sheffield Children's NHS Foundation Trust Western Bank (Site 903)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

teplizumab

Placebo

Arm Description

Sterile solution for injection.

Sterile solution for injection

Outcomes

Primary Outcome Measures

The area under the time-concentration curve (AUC) of C-peptide after a mixed meal tolerance test (MMTT) at Week 78
Clinical Endpoint

Secondary Outcome Measures

Exogenous insulin use
Clinical Endpoint
HbA1c levels
Clinical Endpoint
Time in glycemic target range
Clinical Endpoint
Clinically important hypoglycemic episodes
Clinical Endpoint
Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
Safety Endpoint
Teplizumab serum concentrations
PK Endpoint
Incidence and titers of anti-teplizumab antibodies after treatment courses
Immunogenicity Endpoint

Full Information

First Posted
March 13, 2019
Last Updated
August 23, 2023
Sponsor
Provention Bio, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03875729
Brief Title
Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab
Acronym
PROTECT
Official Title
Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized FcR Non-Binding Anti-CD3 Monoclonal Antibody, in Children and Adolescents With Newly Diagnosed Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 5, 2019 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
May 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Provention Bio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether teplizumab slows the loss of β cells and preserves β cell function in children and adolescent 8-17 years old who have been diagnosed with T1D in the previous 6 weeks.. Subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.
Detailed Description
This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, multi-center study to evaluate the efficacy and safety of teplizumab, a humanized, anti-CD3 monoclonal antibody, in children and adolescents ages 8 through 17 recently diagnosed with type 1 diabetes (within 6 weeks of diagnosis). Approximately 300 participants will be randomized at a ratio of 2:1 to either the teplizumab group or the placebo group. Teplizumab or matching placebo will be administered in two courses 6 months apart. Each course of treatment will include daily infusions for 12 days. The total study duration for each participant will be up to 86 weeks. The primary objective is to determine whether two courses of teplizumab administered 6 months apart slows the loss of β cells and preserves β cell function over 18 months (78 weeks) in children and adolescents 8-17 years old who have been diagnosed with T1D in the previous 6 weeks. The secondary objectives are to evaluate improvements in key clinical parameters of diabetes management, to determine the safety and tolerability of teplizumab, and to evaluate the pharmacokinetics (PK) and immunogenicity of teplizumab

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
T1D, type 1 diabetes, recent-onset T1D

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Phase 3, randomized, double-blind, placebo-controlled, multinational, multicenter study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
328 (Actual)

8. Arms, Groups, and Interventions

Arm Title
teplizumab
Arm Type
Experimental
Arm Description
Sterile solution for injection.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sterile solution for injection
Intervention Type
Biological
Intervention Name(s)
teplizumab
Intervention Description
Treatment
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Control
Primary Outcome Measure Information:
Title
The area under the time-concentration curve (AUC) of C-peptide after a mixed meal tolerance test (MMTT) at Week 78
Description
Clinical Endpoint
Time Frame
Week 78
Secondary Outcome Measure Information:
Title
Exogenous insulin use
Description
Clinical Endpoint
Time Frame
Week 78
Title
HbA1c levels
Description
Clinical Endpoint
Time Frame
Week 78
Title
Time in glycemic target range
Description
Clinical Endpoint
Time Frame
Week 78
Title
Clinically important hypoglycemic episodes
Description
Clinical Endpoint
Time Frame
Week 78
Title
Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
Description
Safety Endpoint
Time Frame
Up to Week 52 and Week 78
Title
Teplizumab serum concentrations
Description
PK Endpoint
Time Frame
78 Week
Title
Incidence and titers of anti-teplizumab antibodies after treatment courses
Description
Immunogenicity Endpoint
Time Frame
78 Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is 8 to 17 years of age, inclusive, at the time of randomization/initiation of study drug administration. Has received a diagnosis of T1D according to the criteria from the American Diabetes Association. Is able to be randomized and initiate study drug within 6 weeks (42 days) of the formal T1D diagnosis. Has a peak stimulated C-peptide of ≥0.2 pmol/mL from a mixed meal tolerance test (MMTT) at screening. Has a positive result on testing for T1D-related autoantibodies. Exclusion Criteria: Has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease. Has an active infection and/or fever. Has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). An individual who has a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer, MD
Organizational Affiliation
Provention Bio, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Rady Children's Hospital-San Diego (Site 004)
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
UCSF Medical Center (Site 001)
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Diablo Clinical Research, Inc. (Site 002)
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
University of Colorado-Barbara Davis Center for Childhood Diabetes (Site 005)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University of Medicine (Site 020)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
UF Clinical and Translation Research Building (Site 015)
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Nemours Children's Specialty Care-Endocrinology (Site 047)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Miami Health System (Site 028)
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
All Children's Hospital-Johns Hopkins Medicine (Site 048)
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
University of South Florida Diabetes and Endocrinology Center (Site 011)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Atlanta Diabetes Associates (Site 009)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Centricity Research (Site 006)
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
St. Luke's Children's Endocrinology (Site 052)
City
Boise
State/Province
Idaho
ZIP/Postal Code
82712
Country
United States
Facility Name
Rocky Mountain Diabetes and Osteoporosis Center (Site 007)
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
University of Chicago Medical Center (Site 017)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University Hospital and Riley Hospital for Children (Site 014)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
U. Iowa Children's Hospital (Site 023)
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Capital Diabetes & Endocrine Associates (Site 029)
City
Camp Springs
State/Province
Maryland
ZIP/Postal Code
20746
Country
United States
Facility Name
Baystate Pediatric Endocrinology & Diabetes (Site 040)
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
U. Minnesota Health Clinical Research Unit (Site 031)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Children's Mercy Hospitals & Clinics (Site 026)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Washington University School of Medicine (Site 018)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Women and Children's Hospital of Buffalo (Site 010)
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
UNC Hospitals Children's Specialty Clinic (Site 038)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Rainbow Babies & Children's Hospital (Site 049)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic (Site 051)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Endocrinology Service Northwest, LLC (Site 034)
City
Bend
State/Province
Oregon
ZIP/Postal Code
97702
Country
United States
Facility Name
Childrens Hospital of Philadelphia - Endocrinology (Site 021)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Sanford Diabetes and Thyroiid Clinical (Site 013)
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
AM Diabetes & Endocrinology Center (Site 008)
City
Bartlett
State/Province
Tennessee
ZIP/Postal Code
38133
Country
United States
Facility Name
Vanderbilt University Medical Center (Site 024)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Children's Medical Center Dallas (Site 033)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Benaroya Research Institute at Virginia Mason (Site 016)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
MultiCare Institute for Research & Innovation (Site 003)
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
UZ Brussel - Campus Jette (Site 202)
City
Bruxelles
State/Province
Brussels Capital Region
ZIP/Postal Code
1090
Country
Belgium
Facility Name
UZ Gent (Site 206)
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CHU UCL Namur, site Clinique Sainte-Elisabeth (Site 205)
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Alberta Diabetes Institute Clinical Research Unit Li Ka Shing Centre for Health Research Innovation (Site 103)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2J3
Country
Canada
Facility Name
BC Diabetes (Site 102)
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Montreal Children's Hospital-McGill (Site 101)
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Fakultni nemocnice v Motole (Site 301)
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Hopitaux Pediatriques de Nice CHU-Lenval service de diabetologie et d'endocrinologia (Site 508)
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
6200
Country
France
Facility Name
CHU Hopital de la Timone-Hopital d'Enfants (Site 512)
City
Marseille
State/Province
Bouces-du-Rhone
ZIP/Postal Code
13005
Country
France
Facility Name
CHU DIJON hopital d'enfant (Site 504)
City
Dijon Cedex
State/Province
cote-d'Or
ZIP/Postal Code
21079
Country
France
Facility Name
Groupe Hospitalier Necker Enfants Malades (site 502)
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75015
Country
France
Facility Name
Centre Hospitalier Regional (CHR) d'Orleans-Service de pediatrie (Site 513)
City
Orleans
State/Province
Loiret
ZIP/Postal Code
45100
Country
France
Facility Name
Groupe hospitalier Est-Hopital Femme, Mere, Enfant (Site 509)
City
Bron Cedex
State/Province
Rhone
ZIP/Postal Code
69677
Country
France
Facility Name
Centre hospitalier de Pau (Site 501)
City
Pau cedex
ZIP/Postal Code
64046
Country
France
Facility Name
Universitätsklinikum Freiburg (Site 603)
City
Freiburg im Breisgau
State/Province
Baden-Wurttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitätsklinikum Heidelberg (Site 608)
City
Heidelberg
State/Province
Baden-Wurtternberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum Augsburg (Site 606)
City
Augsburg
State/Province
Bayem
ZIP/Postal Code
86156
Country
Germany
Facility Name
Evangelisches Klinikum Bethel Kinderklinik (Site 602)
City
Bielefeld
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
33617
Country
Germany
Facility Name
Universitatsklinikum Carl Gustav Carus (Site 601)
City
Dresden
State/Province
Sachson
ZIP/Postal Code
-1307
Country
Germany
Facility Name
Kinderkrankenhaus Auf Der Bult (Site 604)
City
Hannover
ZIP/Postal Code
30173
Country
Germany
Facility Name
Békés Megyei Központi Kórház Pándy Kálmán Tagkórház ( Site 705)
City
Gyula
Country
Hungary
Facility Name
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu (Site 804)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-184
Country
Poland
Facility Name
Instytut Diabetologii Sp. z o.o. (Site 802)
City
Warszawa
ZIP/Postal Code
02-117
Country
Poland
Facility Name
Instytut "Pomnik - Centrum Zdrowia Dziecka" (Site 801)
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne (Site 803)
City
Warszawa
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Northwick Park Hospital - Paediatrics (site 904)
City
London
State/Province
City Of London
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Cardiff and Vale NHS Trust - University Hospital of Wales (Site 902)
City
Cardiff
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
Facility Name
Sheffield Children's NHS Foundation Trust Western Bank (Site 903)
City
Sheffield
ZIP/Postal Code
s10 2TH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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

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