Adults 8 to 17, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in C-peptide ln(AUC+1) Standardized by Duration of the Mixed Meal Tolerance Test (MMTT)Primary· Baseline to Week 78
The area under the concentration-time curve (AUC) of C-peptide was measured after a 4-hour mixed meal tolerance test (MMTT) and is a measure of endogenous insulin production and β cell function. The AUC was computed using the trapezoidal rule and standardized by the duration of the MMTT test, i.e., AUC was divided by the last blood sample collection time (240 minutes or the last collection time for 4h MMTT).
Intent-to-treat
Group
Value
95% CI
Placebo
-0.2112
-0.2437 – -0.1786
Teplizumab
-0.0859
-0.1090 – -0.0628
Per Protocol
Group
Value
95% CI
Placebo
-0.2185
-0.2501 – -0.1869
Teplizumab
-0.0800
-0.1030 – -0.0570
Average Daily Exogenous Insulin UseSecondary· Week 78
The average daily insulin use was calculated based on participants who have at least 3 days of insulin use recorded in the dairy for the Week 78 visit.
Intent-to-treat
Group
Value
95% CI
Placebo
0.593
0.470 – 0.716
Teplizumab
0.463
0.363 – 0.562
Per Protocol
Group
Value
95% CI
Placebo
0.613
0.538 – 0.687
Teplizumab
0.446
0.390 – 0.502
Change in Glycated Hemoglobin (HbA1c) Levels (%)Secondary· Baseline to Week 78
Change in percentage (%) glycated hemoglobin (HbA1c)
Intent-to-treat
Group
Value
95% CI
Placebo
-1.89
-2.16 – -1.62
Teplizumab
-1.98
-2.17 – -1.78
Per Protocol
Group
Value
95% CI
Placebo
-1.94
-2.21 – -1.67
Teplizumab
-2.07
-2.27 – -1.87
Time in Range for Glycemia ControlSecondary· Week 78
Time in range (%) for glycemia control was assessed using Continuous Glucose Monitoring (CGM). Time in range was defined as daily average percentage of time a participant's glucose is \>= 70 mg/dL and \<=180 mg/dL. Time in range was calculated based on participants who had at least 3 days of CGM data recorded for Week 78 visit with a range of at least 8 hours on a given day.
Intent-to-treat
Group
Value
95% CI
Placebo
62.65
57.38 – 67.92
Teplizumab
67.36
63.70 – 71.03
Per Protocol
Group
Value
95% CI
Placebo
61.44
56.50 – 66.38
Teplizumab
67.61
64.09 – 71.14
Rate of Clinically Important Hypoglycemic EventsSecondary· During the entire study (from the first dose to the last study contact, up to 78 Weeks)
Rate = clinically important hypoglycemic events/patient-year. A clinically important episode was defined as a blood glucose value of \<54 mg/dL (3.0 mmol/L) (i.e., Level 2 Hypoglycemia, International Hypoglycemia Study Group, 2017) or a hypoglycemia event of severe cognitive impairment requiring external assistance (such as seizure, syncope, severe confusion with or without a confirmatory low blood glucose reading) (i.e., Level 3 Hypoglycemia, International Hypoglycemia Study Group 2017). Event rate was calculated for each participant as number of events / total study follow-up time. Total stu
Intent-to-treat
Group
Value
95% CI
Placebo
4.24
3.06 – 5.89
Teplizumab
4.68
3.70 – 5.91
Per protocol
Group
Value
95% CI
Placebo
4.63
3.31 – 6.49
Teplizumab
5.04
3.94 – 6.44
Number of Participants With Adverse Events of Special Interest (AESIs)Secondary· During the entire study (from the first dose to the last study contact, up to 78 Weeks)
AESIs are defined in the protocol and categories in the statistical analysis plan. Participants with multiple events are counted only once for each preferred term and category.
Treatment-emergent AESI
Group
Value
95% CI
Placebo
24
Teplizumab
63
Participants with at least one >= grade 3 infection
Group
Value
95% CI
Placebo
2
Teplizumab
1
Participants with at least one acute mononucleosis-like illness
Group
Value
95% CI
Placebo
3
Teplizumab
17
Participants with at least one lymphoma or other malignancy, including benign tumors
Group
Value
95% CI
Placebo
1
Teplizumab
2
Participants with at least one instance of severe hypoglycemic event
Group
Value
95% CI
Placebo
18
Teplizumab
29
Participants with at least one >=grade 3 liver function abnormality
Group
Value
95% CI
Placebo
0
Teplizumab
8
Participants with at least one >= grade 3 thrombocytopenia
Group
Value
95% CI
Placebo
0
Teplizumab
0
Participants with at least one >= grade 3 neutropenia
Group
Value
95% CI
Placebo
0
Teplizumab
7
Teplizumab Serum ConcentrationsSecondary· Pre-dose samples collected on Days 1, 4, 9, 12 and 28 for each of the two treatment courses, and one post-dose sample collected on Day 9 during the first treatment course.
PK samples were collected prior to dosing except for Day 9 in Course 1. An additional PK sample was collected 45 minutes after infusion on Day 9 in Course 1. Concentration values below Lower Limit of Quantification (2.50 ng/mL) were set to zero for summary statistics. Course 2 day numbers were set relative to the first day of dosing, regardless of normal or modified dosing schedule.
Course 1, Day 1
Group
Value
95% CI
Teplizumab
7.4271
± 628.114
Course 1, Day 4
Group
Value
95% CI
Teplizumab
70.4769
± 50.767
Course 1, Day 9
Group
Value
95% CI
Teplizumab
250.3928
± 44.677
Course 1, Day 9 post-dose
Group
Value
95% CI
Teplizumab
636.4390
± 33.171
Course 1, Day 12
Group
Value
95% CI
Teplizumab
305.6569
± 47.048
Course 1, Day 28
Group
Value
95% CI
Teplizumab
25.0317
± 79.953
Course 2, Day 1
Group
Value
95% CI
Teplizumab
5.5433
± 522.457
Course 2, Day 4
Group
Value
95% CI
Teplizumab
82.0166
± 50.333
Anti-teplizumab Antibody (ADA) Titers After Treatment CoursesSecondary· Baseline through 78 Week
Baseline was defined as the most recent value collected prior to the first dose of study drug. Week 26 Day 187 and Weeks 27 and 34 are planned for subjects under the normal dosing schedule. Week 52 Day 369 and Weeks 53, 56, and 60 are planned for subjects under the modified dosing schedule.
Baseline
Group
Value
95% CI
Teplizumab
65.81
± 182.3
Week 2
Group
Value
95% CI
Teplizumab
177.22
± 278.2
Week 4
Group
Value
95% CI
Teplizumab
817.08
± 275.0
Week 8
Group
Value
95% CI
Teplizumab
1040.58
± 239.1
Week 26 Day 182
Group
Value
95% CI
Teplizumab
834.86
± 226.1
Week 26 Day 187
Group
Value
95% CI
Teplizumab
807.26
± 681.6
Week 27
Group
Value
95% CI
Teplizumab
9257.15
± 222.3
Week 30
Group
Value
95% CI
Teplizumab
9985.29
± 218.7
Incidence of Anti-drug Antibodies (ADA) After Treatment CoursesSecondary· From baseline through Week 78
Baseline is defined as the most recent value collected prior to the first dose of study drug. Week 26 Day 187 and Weeks 27 and 34 are planned for subjects under the normal dosing schedule. Week 52 Day 369 and Weeks 53, 56, and 60 are planned for subjects under the modified dosing schedule.
Baseline
Group
Value
95% CI
Teplizumab
15
Teplizumab
200
Week 2
Group
Value
95% CI
Teplizumab
182
Teplizumab
25
Week 4
Group
Value
95% CI
Teplizumab
178
Teplizumab
26
Week 8
Group
Value
95% CI
Teplizumab
175
Teplizumab
31
Week 26 Day 182
Group
Value
95% CI
Teplizumab
139
Teplizumab
53
Week 26 Day 187
Group
Value
95% CI
Teplizumab
130
Teplizumab
40
Week 27
Group
Value
95% CI
Teplizumab
167
Teplizumab
8
Week 30
Group
Value
95% CI
Teplizumab
169
Teplizumab
7
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse events = from the first dose of study drug administration through the end of the study, up to 78 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Provention Bio, Inc.
Last refreshed: 24 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03875729.