EUCTR2020-001317-20-LT进行中（未招募）1 期
A Phase IIa, randomized, double-blind, dose comparison, placebo-controlled, multi-centre clinical trial to evaluate the immune signature of the treatment with the Imotope™ IMCY-0098 and its effect on the preservation of beta-cell function in adult patients with a recent onset Type 1 diabetes
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Imcyse SA
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •(1) Have given written informed consent.
- •(2) Participants aged =18 years and < 45 years at the time of consent.
- •(3) Must have a diagnosis of T1D within maximum 9 weeks duration at screening (date of the first insulin injection).
- •(4) Must have at least one or more diabetes-related autoantibodies present at screening (GAD65, IA-2, or ZnT8).
- •(5) Must have random C-peptide levels =200 pmol/L measured at screening.
- •(6) Must be HLA DR4 positive for the main study.
- •a. Up to 24 participants with an HLA DR4 negative status but HLA DR3 positive will be eligible for the sub-study.
- •(7) Must be willing to comply with intensive diabetes management.
- •(8) Be treated with insulin therapy in accordance with local standard of care.
- •(9) Males with reproductive potential must agree to use adequate contraception up to 90 days after the completion of the last treatment. This includes:
- •- Barrier contraception (condom and spermicide) or
- •- True abstinence (where this is in accordance with the participants preferred and usual lifestyle)
- •(10) All females must have a negative serum pregnancy test at screening. Women sexually active and of childbearing potential must agree to use a highly effective contraception method from screening up to 90 days after last treatment with the investigational product.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 84
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •(1) Clinically significant abnormal full blood count (FBC), renal function or liver function at screening, including
- •a.Be immunodeficient or have clinically significant chronic lymphopenia: Leukopenia (< 3,000 leukocytes /µL), neutropenia (<1,500 neutrophils/µL), lymphopenia (<800 lymphocytes/µL), or thrombocytopenia (<100,000 platelets/µL).
- •b.Evidence of renal dysfunction with creatinine greater than 1.5 times the upper limit of normal.
- •c.Evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal. Participants with elevated unconjugated bilirubin (Gilbert's syndrome) are eligible if bilirubin is = 3 times the upper limits of normal and hepatic enzymes and function are otherwise normal (AST/ALT/Alkaline phosphatase within ULN), and there is no evidence of hemolysis.
- •(2) Have signs or symptoms of serious active infection requiring IV antibiotics and/or hospitalization at study entry.
- •(3) Have signs or symptoms of active COVID infection or a positive COVID PCR test during the screening period.
- •(4) Has received any live, attenuated vaccine within 3 months prior to the first planned administration of the study product (which includes, but not limited to: oral poliomyelitis vaccine, measles-mumps-rubella vaccine, yellow fever vaccine, Japanese encephalitis vaccine, dengue vaccine, rotavirus vaccine, varicella vaccine, live-attenuated zoster vaccine, Bacillus Calmette-Guérin [BCG] vaccine, oral typhoid vaccine).
- •(5) Be currently pregnant or lactating, or anticipate getting pregnant until at least 24 weeks after last study drug administration.
- •(6) Require the use of immunosuppressive agents including chronic use of systemic steroids. Topical, inhalational or intranasal corticosteroids are allowed.
- •(7) Have evidence of current or past human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection.
- •(8) Presence of any uncontrolled disease (including uncontrolled autoimmune disease) or abnormal clinical laboratory results that may interfere with study conduct as judged by the investigator.
- •(9) History of, or current malignancy (except excised basal cell skin cancer).
- •(10) Current or ongoing use of non-insulin pharmaceuticals that affect glycaemic control within the 7 days prior to screening visit.
- •(11) Active participation in another T1D treatment study or any investigational intervention study in the previous 30 days.
- •(12) Known hypersensitivity to any component of the drug product.
- •(13) CRO or Sponsor employees or employees under the direct supervision of the Investigator and/or involved directly in the study.
- •(14) Be diagnosed with Latent Autoimmune Diabetes in Adults (LADA)
研究者
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