πŸ›οΈ Verified NIH Record β€’ Updated 2026-08-06

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 (NCT07088068)

A Randomized, Double-blind, Phase 3 Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Recently Diagnosed Stage 3 Type 1 Diabetes (T1D)

🟒 Recruiting Phase3 πŸ’Š Investigational Drug / Biologic Sponsor: Sanofi

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Scottsdale Clinical Trials- Site Number : 8400044 β€” Scottsdale, Arizona

Age range: 1 Year to 25 Years

πŸ§ͺ Interventions in This Study

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (162 Sites)

Showing the first 25 of 162 sites.

  • Scottsdale Clinical Trials- Site Number : 8400044 β€” Scottsdale, Arizona
  • Marvel Clinical Research- Site Number : 8400042 β€” Huntington Beach, California
  • University of California San Francisco - Mission Bay- Site Number : 8400011 β€” San Francisco, California
  • Barbara Davis Center for Childhood Diabetes- Site Number : 8400031 β€” Aurora, Colorado
  • Yale University School of Medicine- Site Number : 8400005 β€” New Haven, Connecticut
  • University of Florida College of Medicine- Site Number : 8400054 β€” Gainesville, Florida
  • Encore Medical Research - Hollywood- Site Number : 8400061 β€” Hollywood, Florida
  • University of South Florida- Site Number : 8400013 β€” Tampa, Florida
  • AdventHealth Winter Park- Site Number : 8400033 β€” Winter Park, Florida
  • Atlanta Diabetes Associates- Site Number : 8400036 β€” Atlanta, Georgia
  • IACT Health - Columbus - Talbotton Road- Site Number : 8400003 β€” Columbus, Georgia
  • Institute of Endocrinology Diabetes, Health & Hormones- Site Number : 8400050 β€” Stockbridge, Georgia
  • St. Luke's Children's Hospital- Site Number : 8400014 β€” Boise, Idaho
  • Rocky Mountain Clinical Research - Idaho Falls- Site Number : 8400001 β€” Idaho Falls, Idaho
  • Norton Children's Research Institute - Wendy Novak Diabetes Institute- Site Number : 8400016 β€” Louisville, Kentucky
  • C.S. Mott Children's Hospital- Site Number : 8400015 β€” Ann Arbor, Michigan
  • Mayo Clinic in Rochester - Minnesota- Site Number : 8400019 β€” Rochester, Minnesota
  • Park Nicollet Institute - Oncology Research- Site Number : 8400059 β€” Saint Louis Park, Minnesota
  • Children's Mercy Adelle Hall Campus- Site Number : 8400010 β€” Kansas City, Missouri
  • University At Buffalo - Jacobs School Of Medicine- Site Number : 8400006 β€” Buffalo, New York
  • Endocrine Associates of West Village- Site Number : 8400064 β€” New York, New York
  • Columbia University Irving Medical Center- Site Number : 8400009 β€” New York, New York
  • Asheville Clinical Research- Site Number : 8400045 β€” Asheville, North Carolina
  • Cincinnati Children's Hospital Medical Center- Site Number : 8400018 β€” Cincinnati, Ohio
  • The Ohio State University- Site Number : 8400051 β€” Columbus, Ohio

πŸ“ž Contact the Study Coordinator

Phone: (800) 633-1610

Email: contact-us@sanofi.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—