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Teplizumab for Type 1 Diabetes

Phase 2
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
Participant is willing to forego other forms of experimental treatment during the entire study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 78 weeks
Awards & highlights

Study Summary

This trial is for people who have developed type 1 diabetes after taking part in another trial testing a different diabetes treatment. The people in this trial will receive teplizumab, which may help to prevent or delay the onset of type 1 diabetes.

Who is the study for?
This trial is for individuals who were previously part of the TN-10 study and have been diagnosed with type 1 diabetes according to ADA criteria after that study ended. They must start teplizumab treatment within a year of diagnosis, agree not to use other experimental treatments, and provide informed consent. People with active infections, certain medical conditions or past/present HIV, HBV, or HCV are excluded.Check my eligibility
What is being tested?
The trial is testing teplizumab in participants who developed type 1 diabetes after being in an earlier NIH-sponsored study. Those eligible can receive teplizumab within one year of their diagnosis as part of this extension study.See study design
What are the potential side effects?
While specific side effects for this trial aren't listed here, generally speaking, drugs like teplizumab could potentially cause immune system reactions, infusion-related responses such as fever or chills, and possibly increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I agree not to participate in other experimental treatments during this study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~78 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 78 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Secondary outcome measures
Body Weight Changes
Clinical Parameter 1 of Diabetes Management
Clinical Parameter 2 of Diabetes Management
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Teplizumab treatedExperimental Treatment1 Intervention
Administration of teplizumab by intravenous infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Teplizumab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Provention Bio, Inc.Lead Sponsor
10 Previous Clinical Trials
1,340 Total Patients Enrolled
Global Project HeadStudy DirectorProvention, a Sanofi Company
2 Previous Clinical Trials
208 Total Patients Enrolled

Media Library

teplizumab Clinical Trial Eligibility Overview. Trial Name: NCT04270942 — Phase 2
Type 1 Diabetes Research Study Groups: Teplizumab treated
Type 1 Diabetes Clinical Trial 2023: teplizumab Highlights & Side Effects. Trial Name: NCT04270942 — Phase 2
teplizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04270942 — Phase 2
Type 1 Diabetes Patient Testimony for trial: Trial Name: NCT04270942 — Phase 2

Frequently Asked Questions

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

Could you please tell us how many different places are coordinating this research?

"To reduce inconvenience for participants, this clinical trial has 5 different enrolment sites. These are located in Nashville, Gainesville and New Haven as well as other places."

Answered by AI

How many people have been selected to participate in this research project?

"Yes, this is an ongoing study that is actively recruiting patients. The trial was established on March 2nd, 2020 and the most recent update was on September 27th, 2022. They are looking for 30 individuals to participate at 5 different sites."

Answered by AI

Is this the first time that teplizumab has been used in a clinical trial?

"Teplizumab was first studied in 2019 at CHRU de Besancon-Hopital Jean Minjoz-(Site 511). So far, there have been six completed studies. There are presently two live studies being conducted, with a large number of these studies taking place in Nashville, Tennessee."

Answered by AI

When might teplizumab be available to the general public?

"While there is some data suggesting teplizumab is safe, as this is only a Phase 2 trial, no efficacy has been proven yet. Therefore, it receives a score of 2."

Answered by AI

To your knowledge, is this a groundbreaking study?

"There are 66 cities and 9 countries with active teplizumab clinical trials. The first study was conducted in 2019 by Provention Bio, Inc. This initial trial had 300 patients and completed its Phase 3 drug approval stage. In the 2 years since 2019, 6 more trials have been completed."

Answered by AI

Are we still looking for volunteers to participate in this research?

"If you're interested, this trial could use your help. According to the latest update on clinicaltrials.gov (September 27th, 2020), the study is still looking for willing participants."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
How old are they?
18 - 65
What site did they apply to?
Clinical Site
Clinical site
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

My son was diagnosed on the 14th of February 2022. My heart breaks for him every day. If there is any hope, once safe, I owe it to him to do all I can to get him the hrlp.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)
2020. "At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04270942.
~1 spots leftby Apr 2025
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