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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 723

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Teplizumab

Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion

OTHER

Placebo

Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-06
Primary Completion
2028-06-06
Completion
2028-12-12
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Czechia
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07088068 on ClinicalTrials.gov