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

Conditions

• Type 1 Diabetes Mellitus

Eligibility Criteria

Sex

ALL

Age

1 Year - 25 Years

Healthy Volunteers

Not accepted

Interventions

• Teplizumab — DRUG
  Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion
• Placebo — OTHER
  Pharmaceutical form: Solution for injection 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

Start date

Aug 6, 2025

Status verified

Jun 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 (32)

Find similar trials in Scottsdale, AZ

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