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

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04598893
• Other study ID #: PRV-031-003
• Status: Active, not recruiting
• Start date: October 26, 2020
• Est. completion date: November 2026

Study information

• Verified date: April 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 188
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Biological:
• Teplizumab
Received teplizumab in PROTECT Study

Other:
• Placebo
Received placebo in PROTECT study

Locations

Country	Name	City	State
Belgium	University Hospital Brussels (Site 056202)	Jette	Brussels
Belgium	UCL Namur University Hospital Place Louise Godin 15 (Site 056205)	Namur
Canada	Alberta Diabetes Institute, 2-004 Li Ka Shing Centre for Health Research Innovation 8602 (Site 124103)	Edmundston	Alberta
Canada	BCDiabetes - Medical Research Center, 210 West Broadway Suite 400 (Site 124102)	Vancouver	British Columbia
Czechia	University Hospital Motol V Uvalu 84, Praha 5 - Motol (Site 203301)	Prague
France	Woman Mother Child Hospital HCL	Bron
France	Dijon University Hospital Center-Francois Mitterand Hospital, Children's Hospital	Dijon Cedex
France	CHU La Timone - La Timone Children's Hospital	Marseille
France	Lenval Hospital, 57 Avenue de la Californie (Site 250508)	Nice
France	Hospital Center Regional D'Orleans Hospital La Source, Pediatric Department, 14 Hospital Ave Post box 86709 (Site 250513)	Orleans
France	Necker Children's Hospital, 149 Rue de Sevres (Site 250502)	Paris
France	Pau Hospital Center	Pau
Germany	Hospital Augsburg, Stenglinstrasse 2 (Site 276606)	Augsburg
Germany	Evangelic Clinic Bethel, Children's Clinic Grenzweg 14/Hs 2 (Site 276602)	Bethel	Bielefeld
Germany	University Hospital Carl Gustav Carus Fetscherstrasse 74 (Site 276601)	Dresden
Germany	Pediatric Hospital on the Bult Janusz-Korczak-Allee 12 (Site 276604)	Hannover
Germany	University Hospital Heidelberg, Im Neuenheimer Feld 430 (Site 276608)	Heidelberg
Poland	University Teaching Centre, Department of Pediatrics, Diabetology and Endocrinology (Site 616803)	Gdansk
Poland	Children's Memorial Health Institute Al. Dzieci Polskich 20 (Site 616801)	Warsaw
Poland	Institute of Diabetology ul. Raclawicka 129/2U, 02-117 (Site 616802)	Warsaw
Poland	University Teaching Centre of the Medical University of Warsaw, 63A, ul. Zwirki i Wigur (Site 616804)	Warsaw
United Kingdom	Sheffield Children's Hospital Western Bank, S10 2TH (Site 826903)	Sheffield	Yorkshire
United States	Atlanta Diabetes Associates 1800 Howell Mill Road. Suite 450 (Site 840009)	Atlanta	Georgia
United States	Barbara Davis Center for Diabetes - Pediatrics 1775 Aurora Court (Site 840005)	Aurora	Colorado
United States	AM Diabetes & Endocrinology Center, 3025 Kate Bond Rd. (Site 840008)	Bartlett	Tennessee
United States	Endocrinology Service Northwest, LLC 929 SW Simpson Ave. Suite 220 (Site 840034)	Bend	Oregon
United States	St. Luke's Children's Endocrinology, 305 E Jefferson St. (Site 840052)	Boise	Idaho
United States	UBMD Pediatrics 1001 Main Street, 4th Floor (Site 840010)	Buffalo	New York
United States	Capital Medical Research Associates (Site 840029)	Camp Springs	Maryland
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
United States	Centricity Research (Site 840006)	Columbus	Georgia
United States	UT Southwestern Children's Medical Center of Dallas 1935 Medical District Drive (Site 840033)	Dallas	Texas
United States	Rocky Mountain Clinical Research, LLC 3910 Washington Parkway, Suite E (Site 840007)	Idaho Falls	Idaho
United States	Indiana University Hospital, Indiana Clinical Research Center, 550 North University Boulevard (Site 840014)	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics 200 Hawkins Drive (Site 840023)	Iowa City	Iowa
United States	Nemours Children's Health, 807 Children's Way	Jacksonville	Florida
United States	Children's Mercy Hospitals and Clinics, 2401 Gillham Road (Site 840026)	Kansas City	Missouri
United States	Vanderbilt University Medical Center 1500 21st Avenue, Suite 1514, Village At Vanderbilt (Site 840024)	Nashville	Tennessee
United States	Children's Hospital of Philadelphia, Division of Endocrinology 3500 Civic Center Blvd., Buerger Center 12th Floor (Site 840021)	Philadelphia	Pennsylvania
United States	Washington University School of Medicine, Pediatric Clinical Research Unit, Suite 11W19 (Site 840018)	Saint Louis	Missouri
United States	Johns Hopkins All Children's Hospital, 501 6th Avenue South (Site 840048)	Saint Petersburg	Florida
United States	Rady Children's Hospital 3020 Children's Way (Site 840004)	San Diego	California
United States	UCSF Medical Center Gateway Medical Building, 1825 Fourth Street (Site 840001)	San Francisco	California
United States	Virginia Mason Medical Center, Benaroya Research Institute 1201 9th Ave, MS: D4-CRP (Site 840016)	Seattle	Washington
United States	Baystate Medical Center, 759 Chestnut Street	Springfield	Massachusetts
United States	MultiCare Health System, Gateway Medical Building (Site 840003)	Tacoma	Washington
United States	Diablo Clinical Research2255 Ygnacio Valley Road, Ste. M (Site 840002)	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Provention Bio, a Sanofi Company

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czechia,  France,  Germany,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies	Safety outcome	During 42 months of follow-up
Secondary	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	During the 42 months of follow-up
Secondary	Insulin use (daily average insulin dose in U/kg/day)	Clinical parameters of diabetes management 2	During the 42 months of follow-up
Secondary	HbA1c	Clinical parameters of diabetes management 3	During the 42 months of follow-up