Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes

NCT06791291 | Recruiting Phase 2

• 3 other identifiers: ACT18487U1111-1308-1324jRCT2031240637
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 11

Brief Summary

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

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• Number of participants with Stage 3 Type 1 Diabetes based on American Diabetes Association criteria

  From baseline up to Week 104

• Change from baseline in area under the curve (AUC) of C-peptide

  From baseline up to Week 104

• Change from baseline in endogenous insulin

  From baseline up to Week 104

• Number of participants with TEAEs, SAEs, AEs leading to permanent study intervention- or study discontinuation; AEs of special interest; number of participants with clinically significant changes in vital signs, ECG, and/or safety laboratory test

  TEAE: treatment-emerged adverse event; SAE: serious adverse event; AE: adverse event

  Throughout the study, approximately 756 days

Secondary Outcomes (6)

• Change from baseline in fasting plasma glucose (FPG) from an oral glucose tolerance test

  From baseline up to Week 104

• Change from baseline in 2-hour plasma glucose from an oral glucose tolerance test

  From baseline up to Week 104

• Change from baseline of hemoglobin A1c (HbA1c)

  From baseline up to Week 104

• Serum concentration of teplizumab

  From Day 1 to Day 28

• Number of participants with anti-drug antibodies

  From baseline up to Week 104

Study Arms (2)

Teplizumab

EXPERIMENTAL

Participants will receive Teplizumab via IV infusion

Drug: Teplizumab

Control

NO INTERVENTION

Participants will receive no treatment in the control group

Interventions

Teplizumab DRUG

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

Also known as: SAR446681, TZIELD

Teplizumab

Eligibility Criteria

• Age: 8 Years - 34 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female Japanese participant, 8 (inclusive) to 34 years (inclusive) of age, at the time of signing the informed consent. Japanese: born in Japan or ethnic Japanese born outside of Japan, and a descendent of 4 ethnic Japanese grandparents who were all born in Japan.
• Confirmed diagnosis of Stage 2 T1D based on following criteria:
• Participant is positive for 2 or more T1D related auto-antibodies (confirmed by written medical history and/or obtained at study screening). The autoantibodies that are to be confirmed are anti-GAD (glutamic acid decarboxylase), anti-IA2 (insulinoma-associated antigen 2), anti-insulin, anti-ZnT8 (zinc transporter 8), and/or ICA (islet cell antibody).
• Oral glucose tolerance test (OGTT) or blood HbA1c confirms the participant has dysglycemia without overt hyperglycemia.
• Participant must be in good health (except for being Stage 2 T1D) as determined by medical e)valuation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG) XE " ECG " \\f Abbreviation \\t "electrocardiogram" .
• Participant is up to date with routine age-appropriate immunizations according to current local specific guideline prior to randomization.
• Female participants should use contraceptives consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• A female participant is considered fertile (woman of childbearing potential - WOCBP) from the time of menarche until becoming postmenopausal unless permanently sterile. Female participants are eligible to participate if one of the following conditions applies:
• Is a woman of nonchildbearing potential (WONCBP) OR
• Is a WOCBP and agrees to keep abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, or use other highly effective contraceptive method, from signing of the informed consent to at least 3 months and 2 weeks after randomization and agrees not to donate or cryopreserve eggs (ova, oocytes) for the purpose of reproduction during this period.
• A WOCBP must have at least a negative highly sensitive pregnancy test within 48 hours before the administration of study intervention.
• If a urine test cannot be confirmed as negative (eg, an ambiguous result), a blood pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
• Participants are excluded from the study if any of the following criteria apply:
• Any presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, dermatologic, hepatic, renal, metabolic (except Stage 2 T1D), hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
• Participant has clinical signs and symptoms consistent with COVID19, eg, fever, dry cough, dyspnea, loss of taste and smell, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening. Participant who had severe course of COVID-19 (ie, hospitalization, extracorporeal membrane oxygenation, mechanically ventilated).

Sponsors & Collaborators

• Sanofi: lead

Study Sites (11)

Investigational Site Number : 3920015

Ichikawa, Chiba, 272-0827, Japan

RECRUITING

Investigational Site Number : 3920006

Sapporo, Hokkaido, 060-8543, Japan

RECRUITING

Investigational Site Number : 3920018

Kobe, Hyōgo, 650-0017, Japan

RECRUITING

Investigational Site Number : 3920007

Yahaba, Iwate, 028-3695, Japan

RECRUITING

Investigational Site Number : 3920019

Yokohama, Kanagawa, 222-0036, Japan

RECRUITING

Investigational Site Number : 3920001

Iruma, Saitama, 350-0495, Japan

RECRUITING

Investigational Site Number : 3920010

Chūō, Yamanashi, 409-3898, Japan

RECRUITING

Investigational Site Number : 3920017

Fukuoka, 812-0025, Japan

RECRUITING

Investigational Site Number : 3920016

Kyoto, 606-8507, Japan

RECRUITING

Investigational Site Number : 3920004

Osaka, 545-8586, Japan

RECRUITING

Investigational Site Number : 3920020

Tokyo, 101-8309, Japan

RECRUITING

Related Links

• ACT18487 Plain Language Results Summary

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

teplizumab

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; contact-us@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 24, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): March 6, 2028
• Study Completion (Estimated): March 6, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

JP (11)