Diabetes Mellitus, Type 1Phase 2NCT04270942
At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)
A Phase 2 study testing teplizumab 1 mg/mL in people with Diabetes Mellitus, Type 1, run by Provention Bio, a Sanofi Company at 8 sites in United States.
Trial summary
This study was an extension of the NIH-sponsored At-Risk (TN-10) type 1 diabetes study (NCT 01030861). Teplizumab-treated and placebo-treated participants in the NIH trial who developed clinical type 1 diabetes after the conclusion of that trial, were eligible to enroll and receive teplizumab treatment within one year… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- teplizumab 1 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 8 sitesUnited States
- Study dates
- 26 Feb 2020to 22 Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Previous participant in the TN-10 study
- Participant had received a diagnosis of type 1 diabetes after the conclusion of the TN-10 study, according to the criteria from the American Diabetes Association (ADA).
- Participant was able to initiate teplizumab treatment required in this study within 1 year of type 1 diabetes diagnosis.
- Participant was willing to forego other forms of experimental treatment during the entire study.
- Participant and/or guardian had given informed consent and assent as applicable.
Who cannot join
- Had an active infection and/or fever.
- Had 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 had a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Barbara Davis Center for Diabetes Site Number : 04
Aurora, Colorado, 80045
Clinical Site
Aurora, Colorado, 80045
Clinical Site
Gainesville, Florida, 32610
University of Florida Site Number : 02
Gainesville, Florida, 32610
Clinical Site
Nashville, Tennessee, 37232
Vanderbilt Univerity Medical Center Site Number : 03
Nashville, Tennessee, 37232
Yale University School of Medicine Site Number : 01
New Haven, Connecticut, 06511
Clinical Site
New Haven, Connecticut, 06519
About this study
Official title: An Open-Label Study to Evaluate the Safety of Teplizumab (PRV-031) in At-Risk Relatives Who Develop Type 1 Diabetes
This study was an extension of the NIH-sponsored At-Risk (TN-10) type 1 diabetes study (NCT 01030861). Teplizumab-treated and placebo-treated participants in the NIH trial who developed clinical type 1 diabetes after the conclusion of that trial, were eligible to enroll and receive teplizumab treatment within one year of diagnosis of clinical type 1 diabetes.
Read the detailed description
The study was a single-arm, multicenter, open-label clinical trial. All participants received a 12-day course of teplizumab given through daily IV infusion and were followed for 78 weeks.
The purpose of this study was to evaluate the safety and tolerability of teplizumab treatment, administered intravenously (IV) to participants in the NIH-sponsored trial who have developed type 1 diabetes and were able to start teplizumab treatment within 1 year of diagnosis of type 1 diabetes. Whether teplizumab treatment reduced the loss of insulin-producing pancreatic beta cells were evaluated.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- teplizumab 1 mg/mL
- Keywords
- Recent-onset type 1 diabetes, Teplizumab, T1D, Stage 3, Type 1 diabetes, New onset type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teplizumab 1 mg/mLDrug
Also called PRV-031, Tzield
Solution for infusion administered as IV infusion (anti-CD3 humanized monoclonal antibody).
Cumulative dose: 9 mg/m2. Day 1: 106 μg/m2, Day 2: 425 μg/m2, Days 3-12: 850 μg/m2 daily
| Study group | Role | What they receive |
|---|---|---|
| Teplizumab treated | Experimental | Administration of teplizumab by intravenous infusion for 12 consecutive days Receives: Drug: teplizumab 1 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Adverse Events of Special Interest (TEAESIs) and Treatment-emergent Serious Adverse Events (TESAEs)
An AE was any untoward medical occurrence in a participant or clinical study participant,temporally associated with use of study dose,whether or not considered related to study dose.AESI was any AE that met any of following:All >=Grade 3 infections (including all opportunistic infections);acute mononucleosis-like illness;lymphomas or other malignancies;severe hypoglycemic episode;>=Grade 3 liver function abnormalities, thrombocytopenia, neutropenia or rash;>= Grade 4 allergic/hypersensitivity reaction (anaphylaxis) or cytokine-release syndrome; lymphocyte count <500/cubic millimeter for 7 days or longer. An SAE was as any untoward medical occurrence that,at any dose:resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization,resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or any other medically important event.A TEAE was any AE which started during or after the first dose of teplizumab.
Measured: From the first dose of study drug administration (Day 1) up to approximately 78 weeks
Secondary outcomes (7)
Serum Concentration Immediately Prior to Administration of the Next Dose (Ctrough) of Teplizumab at Day 364
Blood samples were collected for evaluation of pharmacokinetic (PK) data.
Measured: Pre-dose on Day 364
Number of Participants With Anti-drug Antibodies (ADA) Against Teplizumab
Blood samples were collected for the evaluation of ADA against teplizumab.
Measured: Up to Day 364
Area Under the Time-Versus-Concentration Curve (AUC) of C-peptide After a 4-hour (4h) Mixed Meal Tolerance Test (MMTT) at Week 78
The AUC of C-peptide was measured after a 4-hour MMTT as a measure of assessing endogenous insulin production and beta cell function. The AUC was computed using the trapezoidal rule and standardized by the duration of the MMTT test for the analysis.
Measured: Week 78
Glycated Hemoglobin (HbA1c) Levels at Week 78
Blood samples were collected for evaluation of HbA1c.
Measured: Week 78
Average Daily Use of Exogenous Insulin at Week 78
The average daily insulin use was calculated based on participants who had at least 3 days of insulin use recorded in the diary for the Week 78 visit.
Measured: Week 78
Number of Participants With Severe Hypoglycemic Episodes
The severity of a hypoglycemia event was identified by the Investigator and classified according to National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 as follows:
- Grade 3 hypoglycemia: 30-39 milligram/deciliter (mg/dL) (1.7-2.1 millimole [mmol]/L). This is considered severe or medically significant but not immediately life-threatening. Hospitalization or prolongation of hospitalization is likely indicated. It is considered disabling and limits self-care.
- Grade 4 hypoglycemia: <=29 mg/dL (1.6 mmol/L). This is considered life threatening (seizures) with urgent intervention indicated.
- Grade 5 hypoglycemia: Hypoglycemia resulting in death. Hypoglycemia >=Grade 3 was considered as severe hypoglycemia.
Measured: From the first dose of study drug administration (Day 1) up to approximately 78 weeks
Number of Participants With Change in Cluster of Differentiation (CD)8+ TIGIT+ KLRG1+ T Cells
CD8+ TIGIT+ KLRG1+ T cells were measured using flow cytometry.
Measured: From the first dose of study drug administration (Day 1) up to approximately 78 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start26 Feb 2020
- Primary completion22 Jan 2024
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, multicenter, open-label clinical trial
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Provention Bio, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270942
- Sponsor's protocol ID
- PRV-031-002
- Other IDs
- SFY18115
- Status last verified
- Jan 2025
- First submitted
- 10 Feb 2020
- Last updated
- 12 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Safety of Teplizumab (PRV-031) in At-Risk Relatives Who Develop Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04270942
- Acronym / sponsor ID
- PRV-031-002
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Recent-onset type 1 diabetes, Teplizumab, T1D, Stage 3, Type 1 diabetes, New onset type 1 diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Provention Bio, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Posted 12 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was an extension of the NIH-sponsored At-Risk (TN-10) type 1 diabetes study (NCT 01030861). Teplizumab-treated and placebo-treated participants in the NIH trial who developed clinical type 1 diabetes after the conclusion of that trial, were eligible to enroll and receive teplizumab treatment within one year of diagnosis of clinical type 1 diabetes.
Detailed description
The study was a single-arm, multicenter, open-label clinical trial. All participants received a 12-day course of teplizumab given through daily IV infusion and were followed for 78 weeks.
The purpose of this study was to evaluate the safety and tolerability of teplizumab treatment, administered intravenously (IV) to participants in the NIH-sponsored trial who have developed type 1 diabetes and were able to start teplizumab treatment within 1 year of diagnosis of type 1 diabetes. Whether teplizumab treatment reduced the loss of insulin-producing pancreatic beta cells were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, multicenter, open-label clinical trial
| Arm | Type | Receives |
|---|---|---|
| Teplizumab treated | Experimental | Drug: teplizumab 1 mg/mLAdministration of teplizumab by intravenous infusion for 12 consecutive days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Previous participant in the TN-10 study
- Participant had received a diagnosis of type 1 diabetes after the conclusion of the TN-10 study, according to the criteria from the American Diabetes Association (ADA).
- Participant was able to initiate teplizumab treatment required in this study within 1 year of type 1 diabetes diagnosis.
- Participant was willing to forego other forms of experimental treatment during the entire study.
- Participant and/or guardian had given informed consent and assent as applicable.
Key exclusion criteria (3 listed)
- Had an active infection and/or fever.
- Had 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 had a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| teplizumab 1 mg/mLAlso: PRV-031, TzieldSolution for infusion administered as IV infusion (anti-CD3 humanized monoclonal antibody). Cumulative dose: 9 mg/m2. Day 1: 106 μg/m2, Day 2: 425 μg/m2, Days 3-12: 850 μg/m2 daily | Drug | Teplizumab treated |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Adverse Events of Special Interest (TEAESIs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: From the first dose of study drug administration (Day 1) up to approximately 78 weeks
An AE was any untoward medical occurrence in a participant or clinical study participant,temporally associated with use of study dose,whether or not considered related to study dose.AESI was any AE that met any of following:All >=Grade 3 infections (including all opportunistic infections);acute mononucleosis-like illness;lymphomas or other malignancies;severe hypoglycemic episode;>=Grade 3 liver function abnormalities, thrombocytopenia, neutropenia or rash;>= Grade 4 allergic/hypersensitivity reaction (anaphylaxis) or cytokine-release syndrome; lymphocyte count <500/cubic millimeter for 7 days or longer. An SAE was as any untoward medical occurrence that,at any dose:resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization,resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or any other medically important event.A TEAE was any AE which started during or after the first dose of teplizumab.
7 secondary outcomes
Serum Concentration Immediately Prior to Administration of the Next Dose (Ctrough) of Teplizumab at Day 364
Time frame: Pre-dose on Day 364
Number of Participants With Anti-drug Antibodies (ADA) Against Teplizumab
Time frame: Up to Day 364
Area Under the Time-Versus-Concentration Curve (AUC) of C-peptide After a 4-hour (4h) Mixed Meal Tolerance Test (MMTT) at Week 78
Time frame: Week 78
Glycated Hemoglobin (HbA1c) Levels at Week 78
Time frame: Week 78
Average Daily Use of Exogenous Insulin at Week 78
Time frame: Week 78
Number of Participants With Severe Hypoglycemic Episodes
Time frame: From the first dose of study drug administration (Day 1) up to approximately 78 weeks
Number of Participants With Change in Cluster of Differentiation (CD)8+ TIGIT+ KLRG1+ T Cells
Time frame: From the first dose of study drug administration (Day 1) up to approximately 78 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing teplizumab 1 mg/mL in people with Diabetes Mellitus, Type 1, run by Provention Bio, a Sanofi Company at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Adverse Events of Special Interest (TEAESIs) and Treatment-emergent Serious Adverse Events (TESAEs) (time frame: From the first dose of study drug administration (Day 1) up to approximately 78 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.