Diabetes Mellitus, Type 1NCT04598893
Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)
An observational study of Diabetes Mellitus, Type 1, run by Provention Bio, a Sanofi Company at 47 sites in 8 countries.
Trial summary
The purpose of this non-interventional extension study is to continue to collect long-term safety and other clinical data for an additional 42 months in participants who completed the PROTECT study. Read more about this study
- Who is it for?
- Ages 9 to 19 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Teplizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 47 sitesin 8 countries
- Study dates
- 26 Oct 2020to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 9 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants who completed the PROTECT (PRV-031-001) study
Who may be able to join
- Completion of the PRV-031-001 (PROTECT) study by completing the Week 78 visit in that study, regardless of how many doses of study drug were administered.
- Provide written informed consent within 12 months of the Week 78 in the PRV-031-001 study. Written assent will be obtained for participants under 18 years of age at the time of enrollment, according to applicable regulations. If possible, written informed consent and/or assent for the current PROTECT Extension study (PRV-031-003) should be obtained at the final (Week 78) visit in the PROTECT study.
Who cannot join
- 1. Premature discontinuation from the PRV-031-001 (PROTECT) study for any reason.
Trial locations and contacts
47 sites in 8 countries.
47 sites in 8 countries
United States25 sites
Atlanta Diabetes Associates 1800 Howell Mill Road. Suite 450 (Site 840009)
Atlanta, Georgia, 30318
Barbara Davis Center for Diabetes - Pediatrics 1775 Aurora Court (Site 840005)
Aurora, Colorado, 80045
AM Diabetes & Endocrinology Center, 3025 Kate Bond Rd. (Site 840008)
Bartlett, Tennessee, 38133
Endocrinology Service Northwest, LLC 929 SW Simpson Ave. Suite 220 (Site 840034)
Bend, Oregon, 97702
St. Luke's Children's Endocrinology, 305 E Jefferson St. (Site 840052)
Boise, Idaho, 83712
UBMD Pediatrics 1001 Main Street, 4th Floor (Site 840010)
Buffalo, New York, 14203
Capital Medical Research Associates (Site 840029)
Camp Springs, Maryland, 20746
UNC Hospitals, The University of North Carolina at Chapel Hill, Children's Specialty Clinic, 101 Manning Drive (Site 840038)
Chapel Hill, North Carolina, 27514
Centricity Research (Site 840006)
Columbus, Georgia, 31904
UT Southwestern Children's Medical Center of Dallas 1935 Medical District Drive (Site 840033)
Dallas, Texas, 75235
Rocky Mountain Clinical Research, LLC 3910 Washington Parkway, Suite E (Site 840007)
Idaho Falls, Idaho, 83404
Indiana University Hospital, Indiana Clinical Research Center, 550 North University Boulevard (Site 840014)
Indianapolis, Indiana, 46202
University of Iowa Hospitals and Clinics 200 Hawkins Drive (Site 840023)
Iowa City, Iowa, 52242
Nemours Children's Health, 807 Children's Way
Jacksonville, Florida, 32207
Children's Mercy Hospitals and Clinics, 2401 Gillham Road (Site 840026)
Kansas City, Missouri, 64108
Vanderbilt University Medical Center 1500 21st Avenue, Suite 1514, Village At Vanderbilt (Site 840024)
Nashville, Tennessee, 37212
Children's Hospital of Philadelphia, Division of Endocrinology 3500 Civic Center Blvd., Buerger Center 12th Floor (Site 840021)
Philadelphia, Pennsylvania, 19104
Rady Children's Hospital 3020 Children's Way (Site 840004)
San Diego, California, 92123
UCSF Medical Center Gateway Medical Building, 1825 Fourth Street (Site 840001)
San Francisco, California, 94158
Virginia Mason Medical Center, Benaroya Research Institute 1201 9th Ave, MS: D4-CRP (Site 840016)
Seattle, Washington, 98101
Baystate Medical Center, 759 Chestnut Street
Springfield, Massachusetts, 01199
Washington University School of Medicine, Pediatric Clinical Research Unit, Suite 11W19 (Site 840018)
St Louis, Missouri, 63110
Johns Hopkins All Children's Hospital, 501 6th Avenue South (Site 840048)
St. Petersburg, Florida, 33701
MultiCare Health System, Gateway Medical Building (Site 840003)
Tacoma, Washington, 98405
Diablo Clinical Research2255 Ygnacio Valley Road, Ste. M (Site 840002)
Walnut Creek, California, 945981
France7 sites
Woman Mother Child Hospital HCL
Bron, 69677
Dijon University Hospital Center-Francois Mitterand Hospital, Children's Hospital
Dijon, 21079
CHU La Timone - La Timone Children's Hospital
Marseille, 13385
Lenval Hospital, 57 Avenue de la Californie (Site 250508)
Nice, 06200
Hospital Center Regional D'Orleans Hospital La Source, Pediatric Department, 14 Hospital Ave Post box 86709 (Site 250513)
Orléans, France, 45067
Necker Children's Hospital, 149 Rue de Sevres (Site 250502)
Paris, 75015
Pau Hospital Center
Pau, 64046
Germany5 sites
Hospital Augsburg, Stenglinstrasse 2 (Site 276606)
Augsburg, 86156
Evangelic Clinic Bethel, Children's Clinic Grenzweg 14/Hs 2 (Site 276602)
Bethel, Bielefeld, 33617
University Hospital Carl Gustav Carus Fetscherstrasse 74 (Site 276601)
Dresden, 01307
Pediatric Hospital on the Bult Janusz-Korczak-Allee 12 (Site 276604)
Hanover, 30173
University Hospital Heidelberg, Im Neuenheimer Feld 430 (Site 276608)
Heidelberg, 69120
Poland4 sites
University Teaching Centre, Department of Pediatrics, Diabetology and Endocrinology (Site 616803)
Gdansk, 80-952
University Teaching Centre of the Medical University of Warsaw, 63A, ul. Zwirki i Wigur (Site 616804)
Warsaw, Poland, 02-091
Institute of Diabetology ul. Raclawicka 129/2U, 02-117 (Site 616802)
Warsaw, 02-117
Children's Memorial Health Institute Al. Dzieci Polskich 20 (Site 616801)
Warsaw, 04-730
Belgium2 sites
University Hospital Brussels (Site 056202)
Jette, Brussels Capital, B-1090
UCL Namur University Hospital Place Louise Godin 15 (Site 056205)
Namur, Namur, B-5000
Canada2 sites
Alberta Diabetes Institute, 2-004 Li Ka Shing Centre for Health Research Innovation 8602 (Site 124103)
Edmundston, Alberta, T6G 2E1
BCDiabetes - Medical Research Center, 210 West Broadway Suite 400 (Site 124102)
Vancouver, British Columbia, V5Y 3W2
Czechia1 site
University Hospital Motol V Uvalu 84, Praha 5 - Motol (Site 203301)
Prague, 150 06
United Kingdom1 site
Sheffield Children's Hospital Western Bank, S10 2TH (Site 826903)
Sheffield, Yorkshire
About this study
Official title: A Multicenter, Multinational Extension of Study PRV-031-001 to Evaluate the Long-Term Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adolescents With Recent-Onset Type 1 Diabetes Mellitus
The purpose of this non-interventional extension study is to continue to collect long-term safety and other clinical data for an additional 42 months in participants who completed the PROTECT study.
Read the detailed description
This study is the long-term extension of the PRV-031-001 (PROTECT) study. PROTECT 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) in which approximately 300 participants were randomized at a ratio of 2:1 to the teplizumab or placebo and received two courses of treatment administered 6 or 12 months apart with final follow-up at approximately 18 months (78 weeks) after the first dose.
Participants who complete the PROTECT study are invited to enroll in this observational, extension study to collect long-term safety and other clinical data. The decision to participate can be made within 12 months of completing the PROTECT study.
No study drug will be administered during this extension study. Participants will continue to receive standard care for type 1 diabetes from their primary physicians.
Participants will return to the study sites for assessments once every 6 months through Month 42. Therefore, the combined duration of the PROTECT and PROTECT Extension studies will be 60 months.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Teplizumab, Placebo
- 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.
TeplizumabBiological
Received teplizumab in PROTECT Study
PlaceboOther
Received placebo in PROTECT study
| Study group | Role | What they receive |
|---|---|---|
| Teplizumab | Participants who received teplizumab in the PROTECT study Receives: Biological: Teplizumab | |
| Placebo | Participants who received placebo in the PROTECT study Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies
Safety outcome
Measured: During 42 months of follow-up
Secondary outcomes (3)
Area under the time-versus concentration curve (AUC) of C-peptide after a 4-hour (4h) mixed-meal tolerance test (MMTT)
Clinical parameters of diabetes management 1
Measured: During the 42 months of follow-up
Insulin use (daily average insulin dose in U/kg/day)
Clinical parameters of diabetes management 2
Measured: During the 42 months of follow-up
HbA1c
Clinical parameters of diabetes management 3
Measured: During the 42 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start26 Oct 2020
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 188 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
- NCT04598893
- Sponsor's protocol ID
- PRV-031-003
- Status last verified
- Dec 2025
- First submitted
- 16 Oct 2020
- Last updated
- 9 Dec 2025
- Results posted
- No
- 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 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Multinational Extension of Study PRV-031-001 to Evaluate the Long-Term Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adolescents With Recent-Onset Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04598893
- Acronym / sponsor ID
- PRV-031-003
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Recent-onset type 1 diabetes, Teplizumab, T1D, Stage 3, Type 1 diabetes, New onset type 1 diabetes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Provention Bio, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this non-interventional extension study is to continue to collect long-term safety and other clinical data for an additional 42 months in participants who completed the PROTECT study.
Detailed description
This study is the long-term extension of the PRV-031-001 (PROTECT) study. PROTECT 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) in which approximately 300 participants were randomized at a ratio of 2:1 to the teplizumab or placebo and received two courses of treatment administered 6 or 12 months apart with final follow-up at approximately 18 months (78 weeks) after the first dose.
Participants who complete the PROTECT study are invited to enroll in this observational, extension study to collect long-term safety and other clinical data. The decision to participate can be made within 12 months of completing the PROTECT study.
No study drug will be administered during this extension study. Participants will continue to receive standard care for type 1 diabetes from their primary physicians.
Participants will return to the study sites for assessments once every 6 months through Month 42. Therefore, the combined duration of the PROTECT and PROTECT Extension studies will be 60 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teplizumab | – | Biological: TeplizumabParticipants who received teplizumab in the PROTECT study |
| Placebo | – | Other: PlaceboParticipants who received placebo in the PROTECT study |
Who may qualify
- Ages
- 9 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants who completed the PROTECT (PRV-031-001) study
Key inclusion criteria (2 listed)
- Completion of the PRV-031-001 (PROTECT) study by completing the Week 78 visit in that study, regardless of how many doses of study drug were administered.
- Provide written informed consent within 12 months of the Week 78 in the PRV-031-001 study. Written assent will be obtained for participants under 18 years of age at the time of enrollment, according to applicable regulations. If possible, written informed consent and/or assent for the current PROTECT Extension study (PRV-031-003) should be obtained at the final (Week 78) visit in the PROTECT study.
Key exclusion criteria (1 listed)
- 1. Premature discontinuation from the PRV-031-001 (PROTECT) study for any reason.
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 |
|---|---|---|
| TeplizumabReceived teplizumab in PROTECT Study | Biological | Teplizumab |
| PlaceboReceived placebo in PROTECT study | Other | Placebo |
Primary outcome
Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies
Time frame: During 42 months of follow-up
Safety outcome
3 secondary outcomes
Area under the time-versus concentration curve (AUC) of C-peptide after a 4-hour (4h) mixed-meal tolerance test (MMTT)
Time frame: During the 42 months of follow-up
Insulin use (daily average insulin dose in U/kg/day)
Time frame: During the 42 months of follow-up
HbA1c
Time frame: During the 42 months of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- 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
Related trials for Diabetes Mellitus, Type 1
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Active, not recruitingPhase 2
Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
Recruiting
T1CARE: A Trial of a Novel Intervention to Address Social Determinants of Health in Young Adults With Type 1 Diabetes
Type 1 Diabetes
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
RecruitingObservational study
Washed Microbiota Transplantation for Type 1 Diabetes Mellitus
Type 1 Diabetes
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
47 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by Provention Bio, a Sanofi Company at 47 sites in 8 countries.
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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, France, Germany, Poland, Belgium and 3 more countries. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies (time frame: During 42 months of follow-up). 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 9 Dec 2025.