Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)

NCT04598893 · tracked via the Priya Life Science UK tracker

Sponsor

Provention Bio, a Sanofi Company

Phase

Observational

Started

2020-10-26

Last updated

2025-12-09

Condition(s) studied

Diabetes Mellitus, Type 1

Investigational drug(s) / intervention(s)

TeplizumabPlacebo

Teplizumab: Received teplizumab in PROTECT Study

Placebo: Received placebo in PROTECT study

Study 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.

Eligibility

Sex

ALL

Min age

9 Years

Max age

19 Years

Healthy volunteers

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.

Primary outcome measure(s)

Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies — During 42 months of follow-up
Safety outcome

Trial sites (47)

Facility	City	Region
Rady Children's Hospital 3020 Children's Way (Site 840004)	San Diego	California
UCSF Medical Center Gateway Medical Building, 1825 Fourth Street (Site 840001)	San Francisco	California
Diablo Clinical Research2255 Ygnacio Valley Road, Ste. M (Site 840002)	Walnut Creek	California
Barbara Davis Center for Diabetes - Pediatrics 1775 Aurora Court (Site 840005)	Aurora	Colorado
Nemours Children's Health, 807 Children's Way	Jacksonville	Florida
Johns Hopkins All Children's Hospital, 501 6th Avenue South (Site 840048)	St. Petersburg	Florida
Atlanta Diabetes Associates 1800 Howell Mill Road. Suite 450 (Site 840009)	Atlanta	Georgia
Centricity Research (Site 840006)	Columbus	Georgia
St. Luke's Children's Endocrinology, 305 E Jefferson St. (Site 840052)	Boise	Idaho
Rocky Mountain Clinical Research, LLC 3910 Washington Parkway, Suite E (Site 840007)	Idaho Falls	Idaho
Indiana University Hospital, Indiana Clinical Research Center, 550 North University Boulevard (Site 840014)	Indianapolis	Indiana
University of Iowa Hospitals and Clinics 200 Hawkins Drive (Site 840023)	Iowa City	Iowa
Capital Medical Research Associates (Site 840029)	Camp Springs	Maryland
Baystate Medical Center, 759 Chestnut Street	Springfield	Massachusetts
Children's Mercy Hospitals and Clinics, 2401 Gillham Road (Site 840026)	Kansas City	Missouri
Washington University School of Medicine, Pediatric Clinical Research Unit, Suite 11W19 (Site 840018)	St Louis	Missouri
UBMD Pediatrics 1001 Main Street, 4th Floor (Site 840010)	Buffalo	New York
UNC Hospitals, The University of North Carolina at Chapel Hill, Children's Specialty Clinic, 101 Manning Drive (Site 840038)	Chapel Hill	North Carolina
Endocrinology Service Northwest, LLC 929 SW Simpson Ave. Suite 220 (Site 840034)	Bend	Oregon
Children's Hospital of Philadelphia, Division of Endocrinology 3500 Civic Center Blvd., Buerger Center 12th Floor (Site 840021)	Philadelphia	Pennsylvania
AM Diabetes & Endocrinology Center, 3025 Kate Bond Rd. (Site 840008)	Bartlett	Tennessee
Vanderbilt University Medical Center 1500 21st Avenue, Suite 1514, Village At Vanderbilt (Site 840024)	Nashville	Tennessee
UT Southwestern Children's Medical Center of Dallas 1935 Medical District Drive (Site 840033)	Dallas	Texas
Virginia Mason Medical Center, Benaroya Research Institute 1201 9th Ave, MS: D4-CRP (Site 840016)	Seattle	Washington
MultiCare Health System, Gateway Medical Building (Site 840003)	Tacoma	Washington
University Hospital Brussels (Site 056202)	Jette	Brussels Capital
UCL Namur University Hospital Place Louise Godin 15 (Site 056205)	Namur	Namur
Alberta Diabetes Institute, 2-004 Li Ka Shing Centre for Health Research Innovation 8602 (Site 124103)	Edmundston	Alberta
BCDiabetes - Medical Research Center, 210 West Broadway Suite 400 (Site 124102)	Vancouver	British Columbia
University Hospital Motol V Uvalu 84, Praha 5 - Motol (Site 203301)	Prague	Czechia
Hospital Center Regional D'Orleans Hospital La Source, Pediatric Department, 14 Hospital Ave Post box 86709 (Site 250513)	Orléans	France
Woman Mother Child Hospital HCL	Bron	France
Dijon University Hospital Center-Francois Mitterand Hospital, Children's Hospital	Dijon	France
CHU La Timone - La Timone Children's Hospital	Marseille	France
Lenval Hospital, 57 Avenue de la Californie (Site 250508)	Nice	France
Necker Children's Hospital, 149 Rue de Sevres (Site 250502)	Paris	France
Pau Hospital Center	Pau	France
Evangelic Clinic Bethel, Children's Clinic Grenzweg 14/Hs 2 (Site 276602)	Bethel	Bielefeld
Hospital Augsburg, Stenglinstrasse 2 (Site 276606)	Augsburg	Germany
University Hospital Carl Gustav Carus Fetscherstrasse 74 (Site 276601)	Dresden	Germany

+ 7 more sites — see the full list on the official registry below.

Other trials for the same condition

A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes Recruiting

A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults Recruiting

A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE) Recruiting

Supplementation With B. Infantis for Mitigation of Type 1 Diabetes Autoimmunity Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04598893 on ClinicalTrials.gov ↗ ← All trials in the UK