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Teplizumab safety tracked for over 3 years in young diabetes patients

NCT ID NCT04598893

Disease control Sponsor: Provention Bio, a Sanofi Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 188 children and adolescents who completed the PROTECT study to check the long-term safety of teplizumab, an antibody treatment for recent-onset type 1 diabetes. Researchers will monitor side effects, insulin use, and blood sugar control for an additional 42 months. The goal is to understand how safe the drug is over time, not to cure the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

188 people

The number who actually took part.

Started

Oct 2020

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants who completed the PROTECT (PRV-031-001) study

Ages

9 to 19 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 2. 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. Exclusion Criteria: 1\. Premature discontinuation from the PRV-031-001 (PROTECT) study for any reason.

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus type 1 diabetes mellitus 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus, type 1

Contacts and locations

Locations

  • AM Diabetes & Endocrinology Center, 3025 Kate Bond Rd. (Site 840008)

    Bartlett, Tennessee, 38133, United States

  • Alberta Diabetes Institute, 2-004 Li Ka Shing Centre for Health Research Innovation 8602 (Site 124103)

    Edmundston, Alberta, T6G 2E1, Canada

  • Atlanta Diabetes Associates 1800 Howell Mill Road. Suite 450 (Site 840009)

    Atlanta, Georgia, 30318, United States

  • BCDiabetes - Medical Research Center, 210 West Broadway Suite 400 (Site 124102)

    Vancouver, British Columbia, V5Y 3W2, Canada

  • Barbara Davis Center for Diabetes - Pediatrics 1775 Aurora Court (Site 840005)

    Aurora, Colorado, 80045, United States

  • Baystate Medical Center, 759 Chestnut Street

    Springfield, Massachusetts, 01199, United States

  • CHU La Timone - La Timone Children's Hospital

    Marseille, 13385, France

  • Capital Medical Research Associates (Site 840029)

    Camp Springs, Maryland, 20746, United States

  • Centricity Research (Site 840006)

    Columbus, Georgia, 31904, United States

  • Children's Hospital of Philadelphia, Division of Endocrinology 3500 Civic Center Blvd., Buerger Center 12th Floor (Site 840021)

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Memorial Health Institute Al. Dzieci Polskich 20 (Site 616801)

    Warsaw, 04-730, Poland

  • Children's Mercy Hospitals and Clinics, 2401 Gillham Road (Site 840026)

    Kansas City, Missouri, 64108, United States

  • Diablo Clinical Research2255 Ygnacio Valley Road, Ste. M (Site 840002)

    Walnut Creek, California, 945981, United States

  • Dijon University Hospital Center-Francois Mitterand Hospital, Children's Hospital

    Dijon, 21079, France

  • Endocrinology Service Northwest, LLC 929 SW Simpson Ave. Suite 220 (Site 840034)

    Bend, Oregon, 97702, United States

  • Evangelic Clinic Bethel, Children's Clinic Grenzweg 14/Hs 2 (Site 276602)

    Bethel, Bielefeld, 33617, Germany

  • Hospital Augsburg, Stenglinstrasse 2 (Site 276606)

    Augsburg, 86156, Germany

  • Hospital Center Regional D'Orleans Hospital La Source, Pediatric Department, 14 Hospital Ave Post box 86709 (Site 250513)

    Orléans, France, 45067, France

  • Indiana University Hospital, Indiana Clinical Research Center, 550 North University Boulevard (Site 840014)

    Indianapolis, Indiana, 46202, United States

  • Institute of Diabetology ul. Raclawicka 129/2U, 02-117 (Site 616802)

    Warsaw, 02-117, Poland

  • Johns Hopkins All Children's Hospital, 501 6th Avenue South (Site 840048)

    St. Petersburg, Florida, 33701, United States

  • Lenval Hospital, 57 Avenue de la Californie (Site 250508)

    Nice, 06200, France

  • MultiCare Health System, Gateway Medical Building (Site 840003)

    Tacoma, Washington, 98405, United States

  • Necker Children's Hospital, 149 Rue de Sevres (Site 250502)

    Paris, 75015, France

  • Nemours Children's Health, 807 Children's Way

    Jacksonville, Florida, 32207, United States

  • Pau Hospital Center

    Pau, 64046, France

  • Pediatric Hospital on the Bult Janusz-Korczak-Allee 12 (Site 276604)

    Hanover, 30173, Germany

  • Rady Children's Hospital 3020 Children's Way (Site 840004)

    San Diego, California, 92123, United States

  • Rocky Mountain Clinical Research, LLC 3910 Washington Parkway, Suite E (Site 840007)

    Idaho Falls, Idaho, 83404, United States

  • Sheffield Children's Hospital Western Bank, S10 2TH (Site 826903)

    Sheffield, Yorkshire, United Kingdom

  • St. Luke's Children's Endocrinology, 305 E Jefferson St. (Site 840052)

    Boise, Idaho, 83712, United States

  • UBMD Pediatrics 1001 Main Street, 4th Floor (Site 840010)

    Buffalo, New York, 14203, United States

  • UCL Namur University Hospital Place Louise Godin 15 (Site 056205)

    Namur, Namur, B-5000, Belgium

  • UCSF Medical Center Gateway Medical Building, 1825 Fourth Street (Site 840001)

    San Francisco, California, 94158, United States

  • UNC Hospitals, The University of North Carolina at Chapel Hill, Children's Specialty Clinic, 101 Manning Drive (Site 840038)

    Chapel Hill, North Carolina, 27514, United States

  • UT Southwestern Children's Medical Center of Dallas 1935 Medical District Drive (Site 840033)

    Dallas, Texas, 75235, United States

  • University Hospital Brussels (Site 056202)

    Jette, Brussels Capital, B-1090, Belgium

  • University Hospital Carl Gustav Carus Fetscherstrasse 74 (Site 276601)

    Dresden, 01307, Germany

  • University Hospital Heidelberg, Im Neuenheimer Feld 430 (Site 276608)

    Heidelberg, 69120, Germany

  • University Hospital Motol V Uvalu 84, Praha 5 - Motol (Site 203301)

    Prague, 150 06, Czechia

  • University Teaching Centre of the Medical University of Warsaw, 63A, ul. Zwirki i Wigur (Site 616804)

    Warsaw, Poland, 02-091, Poland

  • University Teaching Centre, Department of Pediatrics, Diabetology and Endocrinology (Site 616803)

    Gdansk, 80-952, Poland

  • University of Iowa Hospitals and Clinics 200 Hawkins Drive (Site 840023)

    Iowa City, Iowa, 52242, United States

  • Vanderbilt University Medical Center 1500 21st Avenue, Suite 1514, Village At Vanderbilt (Site 840024)

    Nashville, Tennessee, 37212, United States

  • Virginia Mason Medical Center, Benaroya Research Institute 1201 9th Ave, MS: D4-CRP (Site 840016)

    Seattle, Washington, 98101, United States

  • Washington University School of Medicine, Pediatric Clinical Research Unit, Suite 11W19 (Site 840018)

    St Louis, Missouri, 63110, United States

  • Woman Mother Child Hospital HCL

    Bron, 69677, France

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Other studies related to the condition(s) this trial covers.