Actively Recruiting
Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes
Led by Sanofi · Updated on 2026-04-13
10
Participants Needed
11
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a parallel, Phase 2, two-arm study to assess the efficacy and safety of 14-days intravenous (IV) infusion of teplizumab treatment. Teplizumab has been approved by FDA to delay the onset of Stage 3 Type 1 Diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D. The dose regimen of teplizumab in this study is consistent with the regimen approved by US FDA. Given prior clinical studies conducted in Western countries, this design is appropriate to assess the efficacy, safety and tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity of a 14-day IV infusion regimen of teplizumab in Japanese Stage 2 T1D participants aged 8 to 34 years.
CONDITIONS
Official Title
Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female Japanese participant aged 8 to 34 years at informed consent
- Japanese defined as born in Japan or ethnic Japanese born outside Japan with four ethnic Japanese grandparents born in Japan
- Confirmed Stage 2 Type 1 Diabetes with two or more related autoantibodies (anti-GAD, anti-IA2, anti-insulin, anti-ZnT8, and/or ICA)
- Dysglycemia confirmed by oral glucose tolerance test or blood HbA1c without overt hyperglycemia
- Good health aside from Stage 2 Type 1 Diabetes as determined by medical evaluation including history, physical exam, labs, and ECG
- Up to date with routine age-appropriate immunizations according to local guidelines before randomization
- Female participants must use contraceptives per local regulations
- Female participants who are women of childbearing potential (WOCBP) must agree to abstain or use effective contraception from consent to at least 3 months and 2 weeks after randomization
- Negative highly sensitive pregnancy test within 48 hours before receiving study intervention for WOCBP
You will not qualify if you...
- Presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, dermatologic, hepatic, renal, metabolic (except Stage 2 T1D), hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic, or infectious diseases or acute illness
- Signs or history of COVID-19 infection within last 4 weeks or severe COVID-19 requiring hospitalization
- Recent blood donation or transfusion within specified timeframes before randomization
- History of drug hypersensitivity to biologic medications or known allergy to teplizumab or its components
- History or evidence of tuberculosis or positive TB tests
- Acute or active infection with Epstein Barr virus or cytomegalovirus within 3 months before enrollment
- History of invasive opportunistic infections
- Other autoimmune diseases except stable autoimmune thyroid disease or celiac disease
- History of malignancy within 5 years except certain treated skin or cervical cancers
- Fever ≥38.0°C within 48 hours before randomization or chronic infections needing active treatment within 4 weeks
- Pregnancy or breastfeeding
- Recent live or non-live vaccinations within specified periods before and after randomization
- Current or recent treatments that affect T1D course or immune status within 30 days before randomization
- Previous anti-CD3 antibody treatment
- Recent or planned biologic therapy within defined timeframes
- Participation in other clinical studies with investigational products within exclusion periods
- Specific abnormal hematologic parameters before randomization
- Liver function test abnormalities exceeding defined limits
- Positive tests for hepatitis B, hepatitis C, HIV, or SARS-CoV-2
- Contraindication or allergy to NSAIDs and acetaminophen or antihistamines preventing study participation
- Any condition or reason judged by the Investigator to make the participant unsuitable or at risk of noncompliance
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Investigational Site Number : 3920015
Ichikawa, Chiba, Japan, 272-0827
Actively Recruiting
2
Investigational Site Number : 3920006
Sapporo, Hokkaido, Japan, 060-8543
Actively Recruiting
3
Investigational Site Number : 3920018
Kobe, Hyōgo, Japan, 650-0017
Actively Recruiting
4
Investigational Site Number : 3920007
Yahaba, Iwate, Japan, 028-3695
Actively Recruiting
5
Investigational Site Number : 3920019
Yokohama, Kanagawa, Japan, 222-0036
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6
Investigational Site Number : 3920001
Iruma, Saitama, Japan, 350-0495
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7
Investigational Site Number : 3920010
Chūō, Yamanashi, Japan, 409-3898
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8
Investigational Site Number : 3920017
Fukuoka, Japan, 812-0025
Actively Recruiting
9
Investigational Site Number : 3920016
Kyoto, Japan, 606-8507
Actively Recruiting
10
Investigational Site Number : 3920004
Osaka, Japan, 545-8586
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11
Investigational Site Number : 3920020
Tokyo, Japan, 101-8309
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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