Clinical trial NCT04598893: Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetes Mellitus, Type 1
Keywords: Recent-onset type 1 diabetes
Teplizumab
T1D
Stage 3
Type 1 diabetes
New onset type 1 diabetes
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2020-10-22
Enrollment: 188
Sex: ALL
Minimum age (years): 9
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who completed the PROTECT (PRV-031-001) study

Brief 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.

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.

Eligibility criteria: 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 outcomes:
measure: Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies
timeFrame: During 42 months of follow-up
Secondary outcomes:
measure: Area under the time-versus concentration curve (AUC) of C-peptide after a 4-hour (4h) mixed-meal tolerance test (MMTT)
timeFrame: During the 42 months of follow-up
measure: Insulin use (daily average insulin dose in U/kg/day)
timeFrame: During the 42 months of follow-up
measure: HbA1c
timeFrame: During the 42 months of follow-up
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital 3020 Children's Way (Site 840004)
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center Gateway Medical Building, 1825 Fourth Street (Site 840001)
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research2255 Ygnacio Valley Road, Ste. M (Site 840002)
state: California
city: Aurora
country: United States
facility: Barbara Davis Center for Diabetes - Pediatrics 1775 Aurora Court (Site 840005)
state: Colorado
city: Jacksonville
country: United States
facility: Nemours Children's Health, 807 Children's Way
state: Florida
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital, 501 6th Avenue South (Site 840048)
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates 1800 Howell Mill Road. Suite 450 (Site 840009)
state: Georgia
city: Columbus
country: United States
facility: Centricity Research (Site 840006)
state: Georgia
city: Boise
country: United States
facility: St. Luke's Children's Endocrinology, 305 E Jefferson St. (Site 840052)
state: Idaho
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research, LLC 3910 Washington Parkway, Suite E (Site 840007)
state: Idaho
city: Indianapolis
country: United States
facility: Indiana University Hospital, Indiana Clinical Research Center, 550 North University Boulevard (Site 840014)
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics 200 Hawkins Drive (Site 840023)
state: Iowa
city: Camp Springs
country: United States
facility: Capital Medical Research Associates (Site 840029)
state: Maryland
city: Springfield
country: United States
facility: Baystate Medical Center, 759 Chestnut Street
state: Massachusetts
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics, 2401 Gillham Road (Site 840026)
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine, Pediatric Clinical Research Unit, Suite 11W19 (Site 840018)
state: Missouri
city: Buffalo
country: United States
facility: UBMD Pediatrics 1001 Main Street, 4th Floor (Site 840010)
state: New York
city: Chapel Hill
country: United States
facility: UNC Hospitals, The University of North Carolina at Chapel Hill, Children's Specialty Clinic, 101 Manning Drive (Site 840038)
state: North Carolina
city: Bend
country: United States
facility: Endocrinology Service Northwest, LLC 929 SW Simpson Ave. Suite 220 (Site 840034)
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia, Division of Endocrinology 3500 Civic Center Blvd., Buerger Center 12th Floor (Site 840021)
state: Pennsylvania
city: Bartlett
country: United States
facility: AM Diabetes & Endocrinology Center, 3025 Kate Bond Rd. (Site 840008)
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center 1500 21st Avenue, Suite 1514, Village At Vanderbilt (Site 840024)
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Children's Medical Center of Dallas 1935 Medical District Drive (Site 840033)
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center, Benaroya Research Institute 1201 9th Ave, MS: D4-CRP (Site 840016)
state: Washington
city: Tacoma
country: United States
facility: MultiCare Health System, Gateway Medical Building (Site 840003)
state: Washington
city: Jette
country: Belgium
facility: University Hospital Brussels (Site 056202)
state: Brussels
city: Namur
country: Belgium
facility: UCL Namur University Hospital Place Louise Godin 15 (Site 056205)
city: Edmundston
country: Canada
facility: Alberta Diabetes Institute, 2-004 Li Ka Shing Centre for Health Research Innovation 8602 (Site 124103)
state: Alberta
city: Vancouver
country: Canada
facility: BCDiabetes - Medical Research Center, 210 West Broadway Suite 400 (Site 124102)
state: British Columbia
city: Prague
country: Czechia
facility: University Hospital Motol V Uvalu 84, Praha 5 - Motol (Site 203301)
city: Bron
country: France
facility: Woman Mother Child Hospital HCL
city: Dijon Cedex
country: France
facility: Dijon University Hospital Center-Francois Mitterand Hospital, Children's Hospital
city: Marseille
country: France
facility: CHU La Timone - La Timone Children's Hospital
city: Nice
country: France
facility: Lenval Hospital, 57 Avenue de la Californie (Site 250508)
city: Orleans
country: France
facility: Hospital Center Regional D'Orleans Hospital La Source, Pediatric Department, 14 Hospital Ave Post box 86709 (Site 250513)
city: Paris
country: France
facility: Necker Children's Hospital, 149 Rue de Sevres (Site 250502)
city: Pau
country: France
facility: Pau Hospital Center
city: Bethel
country: Germany
facility: Evangelic Clinic Bethel, Children's Clinic Grenzweg 14/Hs 2 (Site 276602)
state: Bielefeld
city: Augsburg
country: Germany
facility: Hospital Augsburg, Stenglinstrasse 2 (Site 276606)
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus Fetscherstrasse 74 (Site 276601)
city: Hannover
country: Germany
facility: Pediatric Hospital on the Bult Janusz-Korczak-Allee 12 (Site 276604)
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg, Im Neuenheimer Feld 430 (Site 276608)
city: Gdansk
country: Poland
facility: University Teaching Centre, Department of Pediatrics, Diabetology and Endocrinology (Site 616803)
city: Warsaw
country: Poland
facility: University Teaching Centre of the Medical University of Warsaw, 63A, ul. Zwirki i Wigur (Site 616804)
city: Warsaw
country: Poland
facility: Institute of Diabetology ul. Raclawicka 129/2U, 02-117 (Site 616802)
city: Warsaw
country: Poland
facility: Children's Memorial Health Institute Al. Dzieci Polskich 20 (Site 616801)
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital Western Bank, S10 2TH (Site 826903)
state: Yorkshire
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: