2024-519494-19-00招募中3 期
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) (βETA PRESERVE)
Sanofi-Aventis Recherche & Developpement65 个研究点 分布在 6 个国家目标入组 467 人开始时间: 2025年11月25日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 467
- 试验地点
- 65
- 主要终点
- For United States (US) and non-European Union (EU) countries: Glycated hemoglobin (HbA1c) change from baseline
研究概览
简要总结
To demonstrate superiority of teplizumab versus (vs) placebo on glycemic control or prandial insulin independency over 52 weeks
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participant must be 1 to 25 years of age inclusive, at the time of signing the informed consent.
- •Lactating woman must interrupt breastfeeding and pump and discard breast milk during and for 20 days after last administration of study intervention.
- •Capable of giving signed informed consent as described in Appendix 1 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol. Note: For minor participants, a specific ICF must also be signed by the participant’s legally authorized representative (LAR).
- •Participants diagnosed with T1D Stage 3 according to American Diabetes Association 2025 criteria
- •Participants able to be randomized and initiate study drug within 8 weeks (56 days) of the Stage 3 T1D diagnosis
- •Participants must be positive for at least one T1D autoantibody at screening: • Glutamic acid decarboxylase (GAD-65), • Insulinoma Antigen-2 (IA-2), • Zinc-transporter 8 (ZnT8), or • Insulin (if obtained not later than 14 days after exogenous insulin therapy initiation). • Islet cell cytoplasmic autoantibodies (ICAs)
- •Have random C-peptide level ≥0.2 nmol/L obtained at screening
- •Both male and female participants are eligible.
- •Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •A female participant is eligible to participate if she is not pregnant, and one of the following conditions applies: • Is a woman of nonchildbearing potential (WONCBP) OR • Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective, with a failure rate of <1% during the study intervention period (to be effective before starting the intervention) and for at least 30 days after the last administration of study intervention
- •A WOCBP must have a negative highly sensitive pregnancy test at screening (serum) and within 24 hours (urine or serum as required by local regulations) before the first administration of study intervention.
排除标准
- •Participant has diabetes other than autoimmune T1D that includes but is not limited to genetic forms of diabetes, maturity-onset diabetes of the young (MODY), diabetes secondary to medications or surgery and type 2 diabetes by judgement of the Investigator.
- •Past (within 30 days prior to screening) or current administration of any treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status (including but not limited to oral, inhaled or systemically injected steroids with duration >14 days, adrenocorticotropic hormone, verapamil).
- •Past systemic immunosuppression medicine or immune modulatory biologic therapy (such as monoclonal antibodies), within 3 months or 5 half-lifes (whichever is longer) prior to dosing.
- •Current or prior (within 30 days before screening) use of any medication known to significantly influence glucose tolerance (eg, atypical antipsychotics, diphenylhydantoin, niacin).
- •Participant has previously received teplizumab or other anti-CD3 treatment.
- •Other medications not compatible or interfering with IMP at discretion of Investigator.
- •Current enrollment OR past participation in another investigational study in which an investigational intervention (eg, drug, vaccine, invasive device) was administered within the last 8 weeks or 5 half-lifes, whichever is longer, prior to screening.
- •Participant has any of the following laboratory parameters, at screening prior to first dose: • Lymphocyte count: <1000/µL, • Neutrophil count: <1500/µL, • Platelet count: <150,000 platelets/µL, • Hemoglobin: <10 g/dL, • Aspartate aminotransferase (AST) >2.0 × upper limit of normal (ULN), • Alanine aminotransferase (ALT) >2.0 × ULN, • Total bilirubin >1.5 × ULN with the exception of participants with the diagnosis of Gilbert's syndrome who may be eligible provided they have no other causes leading to hyperbilirubinemia
- •Participant has an active serious infection and/or fever ≥38.5°C (101.3°F) within the 48 hours prior to the first dose (except if localized skin infection), or has chronic, recurrent or opportunistic infectious disease.
- •At screening, participant has laboratory or clinical evidence of acute or clinically active infection with Epstein-Barr virus (EBV), cytomegalovirus (CMV).
- •At screening, participant has positive serology for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV).
- •Participant has evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and/or TB testing. Blood testing (eg, QuantiFERON® TB Gold test) is strongly preferred; if not available, any local approved TB test is allowed.
- •Has other autoimmune diseases, (eg, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythematosus etc), except clinically stable autoimmune thyroid disease, or controlled celiac disease (at discretion of Investigator).
- •Any clinically significant abnormality identified either in medical/surgical history or during screening evaluation (eg, physical examination, laboratory tests, vital signs), or any adverse event (AE) during screening period which, in the judgment of the investigator, would preclude safe completion of the study or constrains efficacy assessment.
- •Participant has recent or planned vaccinations as follows: • Live-attenuated (live) vaccines (eg, varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox) within the 8 weeks before first dose of the investigational medicinal product (IMP) or planned/required administration during treatment or up to 26 weeks after last IMP administration in any treatment course. • Inactivated or mRNA vaccines within 2 weeks before the first dose of IMP or planned required administration during treatment or up to 6 weeks after last IMP administration in any treatment course.
- •Current or prior use (within 30 days before screening) of any anti-hyperglycemic agents other than insulin
结局指标
主要结局
For United States (US) and non-European Union (EU) countries: Glycated hemoglobin (HbA1c) change from baseline
For United States (US) and non-European Union (EU) countries: Glycated hemoglobin (HbA1c) change from baseline
For US and non-EU countries: Total number of days without prandial insulin use
For US and non-EU countries: Total number of days without prandial insulin use
For EU countries: Change from baseline in mean 2 hours mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from Area Under the Curve (AUC) in participants 5 years and older
For EU countries: Change from baseline in mean 2 hours mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from Area Under the Curve (AUC) in participants 5 years and older
For EU countries: HbA1c change from baseline
For EU countries: HbA1c change from baseline
For EU countries: Total number of days without prandial insulin use
For EU countries: Total number of days without prandial insulin use
次要结局
- Change from baseline in mean 2 hours MMTT stimulated C-peptide concentration, calculated from AUC
- Participants remaining C-peptide positive (2 hours MMTT stimulated peak C-peptide concentration ≥0.2 nmol/L)
- Incidence of participants with HbA1c ≤6.5% and requiring ≤0.25 IU/kg/day of insulin
- Change from baseline in Time-in-Range (TIR) (70-180 mg/dL blood glucose) assessed by continuous glucose monitoring (CGM)
- Number of level 2 and 3 (according to American Diabetes Association) hypoglycemic events per participant year (event rates)
- Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and TEAEs leading to treatment discontinuation
- Teplizumab PK parameters: Maximum concentration of teplizumab [Cmax]
- Teplizumab PK parameters: Area under the curve [AUC] and [AUClast]
- Incidence of antidrug-antibodies (ADAs)
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Recherche & Developpement
研究点 (65)
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