A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Sanofi
Study ID
NCT07088068
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Teplizumab — DRUG
    Pharmaceutical form: Concentrated solution for infusion Route of administration: Intravenous infusion
  • Placebo — OTHER
    Pharmaceutical form: Concentrated solution for infusion Route of administration: Intravenous infusion

Study Details

This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase 3, 2-arm study for treatment. The purpose of this study is to measure change in glycemic control and prandial insulin independency over 52 weeks with teplizumab compared with placebo, both administered by intravenous (IV) infusion, in participants with recently diagnosed Stage 3 type 1 diabetes (T1D) aged 1 to 25 years, on standard insulin therapy.

Key Dates

First listed
Jul 28, 2025
Start date
Aug 6, 2025
Status verified
Sep 2026
Primary completion
Jun 6, 2028
Completion
Dec 12, 2028

Study Design

Enrollment
723 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Teplizumab
    Participants will receive teplizumab in increasing doses by intravenous administration
  • Placebo Comparator: Placebo
    Participants will receive volume matching placebo doses to the Teplizumab arm by intravenous administration

Primary Outcome Measure

For United States (US) and non-European Union (EU) countries: Glycated hemoglobin (HbA1c) change from baseline [ Time Frame: From Baseline to Week 52 ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (33)

FacilityCityStateZIPSite coordinators
Scottsdale Clinical Trials- Site Number : 8400044ScottsdaleArizona85260-
University of California San Francisco - Mission Bay- Site Number : 8400011San FranciscoCalifornia94158-
Barbara Davis Center for Childhood Diabetes- Site Number : 8400031AuroraColorado80045-
Yale University School of Medicine- Site Number : 8400005New HavenConnecticut06510-
University of Florida College of Medicine- Site Number : 8400054GainesvilleFlorida32610-
Encore Medical Research - Hollywood- Site Number : 8400061HollywoodFlorida33024-
Nemours Children's Speciality Care- Jacksonville- Site Number : 8400040JacksonvilleFlorida32207-
University of South Florida- Site Number : 8400013TampaFlorida33612-
AdventHealth Winter Park- Site Number : 8400033Winter ParkFlorida32792-
Atlanta Diabetes Associates- Site Number : 8400036AtlantaGeorgia30318-
Children's Healthcare of Atlanta - Egleston Hospital- Site Number : 8400065AtlantaGeorgia30322-
IACT Health - Columbus - Talbotton Road- Site Number : 8400003ColumbusGeorgia31904-
St. Luke's Children's Hospital- Site Number : 8400014BoiseIdaho83712-
Rocky Mountain Clinical Research - Idaho Falls- Site Number : 8400001Idaho FallsIdaho83404-
Norton Children's Research Institute - Wendy Novak Diabetes Institute- Site Number : 8400016LouisvilleKentucky40202-
C.S. Mott Children's Hospital- Site Number : 8400015Ann ArborMichigan48109-
Mayo Clinic in Rochester - Minnesota- Site Number : 8400019RochesterMinnesota55905-
Park Nicollet Institute - Oncology Research- Site Number : 8400059Saint Louis ParkMinnesota55426-
Children's Mercy Adelle Hall Campus- Site Number : 8400010Kansas CityMissouri64108-
University At Buffalo - Jacobs School Of Medicine- Site Number : 8400006BuffaloNew York14203-
Columbia University Irving Medical Center- Site Number : 8400009New YorkNew York10032-
Endocrine Associates of West Village- Site Number : 8400064New YorkNew York10001-
Asheville Clinical Research- Site Number : 8400045AshevilleNorth Carolina28803-
UNC Children's Hospital- Site Number : 8400034Chapel HillNorth Carolina27599-
Cincinnati Children's Hospital Medical Center- Site Number : 8400018CincinnatiOhio45229-
The Ohio State University- Site Number : 8400051ColumbusOhio43210-
The Children's Hospital of Philadelphia- Site Number : 8400039PhiladelphiaPennsylvania19104-
AM Diabetes & Endocrinology Center- Site Number : 8400004BartlettTennessee38133-
Baylor College of Medicine- Site Number : 8400057HoustonTexas77030-
University of Utah Health Hospital- Site Number : 8400052Salt Lake CityUtah84132-
Uva Children's Battle Building- Site Number : 8400060CharlottesvilleVirginia22903-
Benaroya Research Institute at Virginia Mason- Site Number : 8400038SeattleWashington98101-
MultiCare Mary Bridge Children's Health Center- Site Number : 8400037TacomaWashington98405-

Find similar trials in Scottsdale, AZ

Nationwide
Type 1 diabetes trialsEndocrinology trials
By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Scottsdale Clinical Trials· Scottsdale, AZUniversity of California San Francisco - Mission Bay· San Francisco, CABarbara Davis Center for Childhood Diabetes· Aurora, COYale University School of Medicine· New Haven, CTUniversity of Florida College of Medicine· Gainesville, FLEncore Medical Research - Hollywood· Hollywood, FL

Related Studies