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Monoclonal Antibodies

teplizumab for Type 1 Diabetes (PROTECT Trial)

Phase 3
Waitlist Available
Research Sponsored by Provention Bio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

PROTECT Trial Summary

This trial will help researchers understand if teplizumab can help preserve beta cells in kids recently diagnosed with Type 1 Diabetes.

Eligible Conditions
  • Type 1 Diabetes

PROTECT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in C-peptide ln(AUC+1) Standardized by Duration of the Mixed Meal Tolerance Test (MMTT)
Secondary outcome measures
Anti-teplizumab Antibody (ADA) Titers After Treatment Courses
Average Daily Exogenous Insulin Use
Change in Glycated Hemoglobin (HbA1c) Levels (%)
+5 more

Side effects data

From 2023 Phase 3 trial • 328 Patients • NCT03875729
70%
Hypoglycaemia
43%
Headache
42%
Nausea
40%
Rash
34%
Lymphocyte count decreased
31%
Vomiting
24%
Pyrexia
24%
White blood cell count decreased
23%
COVID-19
23%
Lymphopenia
20%
Upper respiratory tract infection
17%
Abdominal pain
15%
Neutrophil count decreased
14%
Abdominal pain upper
14%
Diarrhoea
13%
Alanine aminotransferase increased
13%
Neutropenia
13%
Rash maculo-papular
12%
Leukopenia
10%
Fatigue
9%
Chills
9%
Cough
9%
Nasal congestion
9%
Oropharyngeal pain
9%
Aspartate Aminotransferase increased
9%
Nasopharyngitis
8%
Pruritus
8%
Hypotension
7%
Cytokine release syndrome
7%
Pain in extremity
6%
Tachycardia
6%
Anaemia
6%
Proteinuria
6%
Arthralgia
5%
Rhinorrhoea
5%
Dizziness
5%
Rash macular
5%
Decreased appetite
4%
Dermatitis
4%
Gastroenteritis
3%
Erythema
1%
Suicidal ideation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Teplizumab

PROTECT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TeplizumabExperimental Treatment1 Intervention
Teplizumab was administered via intravenous infusion in two courses, with the first course starting on Day 1 (Week 1) and the second course approximately 6 months later at Day 182 (Week 26). Participants who were unable to receive the second 12-day course due to COronaVIrus Disease of 2019 (COVID-19) pandemic restrictions were given the second course at approximately 12 months (Week 52 visit). Each course of treatment included daily infusions for 12 days. Each course included: Day 1: 106 μg/m^2 Day 2: 425 μg/m^2 Days 3-12: 850 μg/m^2 Total per course: 9.0 mg/m^2 The doses of study drug were calculated based on the participant's body surface area (BSA) measured on the first day of each treatment course.
Group II: PlaceboPlacebo Group1 Intervention
Placebo was administered via intravenous infusion in two courses, with the first course starting on Day 1 (Week 1) and the second course approximately 6 months later at Day 182 (Week 26). Participants who were unable to receive the second 12-day course due to COronaVIrus Disease of 2019 (COVID-19) pandemic restrictions were given the second course at approximately 12 months (Week 52 visit). Each course of treatment included daily infusions for 12 days. The placebo solution consisted of the same formulation as the study drug but without teplizumab. Placebo was administered in the same dose volume and by the same treatment schedule as the active drug.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
teplizumab
2019
Completed Phase 3
~340

Find a Location

Who is running the clinical trial?

Provention Bio, Inc.Lead Sponsor
10 Previous Clinical Trials
1,018 Total Patients Enrolled
Provention Bio, MDStudy DirectorProvention Bio, Inc.
3 Previous Clinical Trials
230 Total Patients Enrolled
Chief Medical Officer, MDStudy DirectorProvention Bio, Inc.
22 Previous Clinical Trials
7,038 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are middle-aged adults eligible for this kind of treatment?

"The 8 to 17 age bracket is the only one eligible for this clinical trial."

Answered by AI

How does teplizumab compare to other drugs in its class?

"The first study of teplizumab occurred in 2019 at CHRU de Besancon-Hopital Jean Minjoz. Since then, there have been 18293 completed studies. As of now, there are 2 ongoing clinical trials; a majority of these taking place in Calgary, Alberta."

Answered by AI

Could you tell me how many different locations are conducting this trial?

"Selecting a site from the 47 locations for this clinical trial that is nearest to you can help reduce travel time and costs. The sites are based in cities including Calgary, Boise and Bartlett among other locations."

Answered by AI

What are some possible side effects of teplizumab?

"There is both prior clinical data supporting teplizumab's efficacy and safety, so it received a score of 3."

Answered by AI

Is this clinical trial still looking for participants?

"This study, which was originally posted on April 5th, 2019 and last updated on August 15th, 2022 is not presently looking for patients. Although this trial has completed recruitment, there are 1,314 other trials that are still enrolling individuals."

Answered by AI

Are there other similar trials to this one that have been conducted in the past?

"Since 2019, teplizumab has undergone extensive clinical trials. The first sponsored by Provention Bio, Inc. in 300 people. After the success of the initial study, Phase 3 drug approval was granted and today there are 2 active studies involving 66 cities and 9 countries."

Answered by AI

How many individuals are participating in this research project?

"This particular clinical trial has closed recruitment; however, there are many other diabetes trials (1312 in total) that are still enrolling patients. Additionally, there are 2 trials for teplizumab admitting patients at this time."

Answered by AI

Do I fit the parameters to join this clinical trial?

"This clinical trial is seeking 300 participants that fit the following criteria: they must have diabetes, an autoimmune disease, and be between 8-17 years old."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
California
How old are they?
65+
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab
2019. "Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03875729.
~55 spots leftby Apr 2025
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