NCT05683990进行中（未招募）2 期
DiaPrecise, A Phase II Open Label Study to Evaluate the Safety and Feasibility of Intralymphatic Administration of Diamyd® in Individuals at Risk for Type 1 Diabetes Carrying the HLA DR3-DQ2 Haplotype
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Occurrence of AEs (including Injection site reactions) and SAEs
研究概览
简要总结
A 2-arm randomized Phase II Open Label Study to evaluate the safety and feasibility of intralymphatic administration of Diamyd® (Diamyd) also known as retogatein in individuals at risk of Type 1 diabetes carrying the HLA DR3-DQ2 haplotype.
详细描述
The trial is a 2-arm, randomized, open label clinical trial in individuals aged 8 - <18 years with HLA DR3-DQ2 and multiple islet autoantibodies (Stage 1 or Stage 2) at increased risk for T1D. At baseline eligible individuals at risk of T1D will be randomized 1:1 into 2 or 3 injections of Diamyd® also known as retogatein administered into an inguinal lymph node. Subjects will be followed for a total of 12 months post-enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent/assent from the individual and the individual's parents or caretaker(s) according to local regulations.
- •Males and females aged ≥8 and <18 years old at the time of Screening.
- •Possess the HLA DR3-DQ2 haplotype.
- •Seropositive for GADA and at least one additional T1D-associated autoantibody (IA-2A, ZnT8A or IAA).
排除标准
- •Diagnosis of T1D (stage 3 T1D, according to the American Diabetes Association [ADA] classification).
- •Fasting glucose > 7 mmol/L (126 mg/dl), 2-hour-OGTT plasma glucose > 11.1 mmol/L (200 mg/dL) or HbA1c > 6.5% (48 mmol/mol) at the screening Visit.
- •Treatment with any anti-diabetic medication, including the use of external insulin.
- •Participation in any other clinical trial testing pharmaceutical treatments.
- •Recent (past 12 months) or current treatment with immunosuppressant therapy, including chronic use of glucocorticoid therapy. Inhaled, topical, and intranasal steroid use is acceptable. Short courses (e.g., ≤5 days) of oral or intra-articular injections of steroids will be permitted on trial.
- •History of hyperparathyroidism, hypercalcemia and/or nephrolithiasis, unless appropriately treated, or any other contraindication to use of Vitamin D.
- •History of epilepsy, serious head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
- •Any clinically significant history of an acute reaction to a vaccine or its constituents (e.g., Alhydrogel) or lidocaine (local anesthetic)
- •Any acute or chronic skin infection or condition that would preclude intralymphatic injection.
- •Treatment with any (live or inactive) vaccine, including influenza vaccine and Coronavirus Disease 2019 (COVID-19) vaccine, within 4 weeks prior to planned first dose of study drug; or planned treatment with any vaccine up to 4 weeks after the last injection with study drug.
- •Ongoing diagnosed post-COVID19 syndrome.
- •Known diagnosis of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection. Individuals with previous hepatitis C infection that is now cured may be eligible.
- •Any clinically significant concomitant medical condition, including but not limited to other autoimmune diseases, cardiovascular, gastrointestinal, hematological, immune, renal including a history of renal transplantation or neurological that in the opinion of the investigator would interfere with trial participation or procedures. Celiac disease with adequate diet as well as stable autoimmune thyroiditis will be permitted.
- •Any clinically significant abnormal findings detected during Screening that might jeopardize the individual's safety or ability to complete the trial.
- •Females who are lactating or pregnant (for females who have started menstruating the possibility of pregnancy must be excluded by urine βHCG onsite prior to the study drug administration).
- •Males or females not willing to use adequate contraception, if sexually active, until 90 days after the last Diamyd administration. Adequate contraception is as follows:
- •For females of childbearing potential (FOCBP)
- •oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable, or implanted hormonal contraceptives
- •intrauterine device
- •intrauterine system (for example, progestin-releasing coil)
- •refraining from heterosexual intercourse if that is the preferred and usual lifestyle of the subject.
- •For sexually active males
- •Abstinence from heterosexual intercourse if that is the preferred and usual lifestyle of the subject.
研究组 & 干预措施
Arm 1
Experimental
2 injections of Diamyd
干预措施: Diamyd (Drug)
Arm 2
Experimental
3 injections of Diamyd
干预措施: Diamyd (Drug)
结局指标
主要结局
Occurrence of AEs (including Injection site reactions) and SAEs
时间窗: From screening to 12 months.
Number of Clinically Significant Abnormal Results from Physical examinations, including neurological and Vital Signs assessments
时间窗: From screening to 12 months.
Number of Clinically Significant Abnormal Results From Laboratory measurements, including hematology, clinical chemistry, metabolic status parameters (fasting C-peptide, HbA1c, fasting glucose) and urine analysis
时间窗: From screening to 12 months.
次要结局
- Change in time in range > 10 mmol/L(From screening to 12 months.)
- Stage progression(From screening to 12 months.)
- T1D diagnosis(From screening to 12 months.)
- Time to stage progression(From screening to 12 months.)
- OGTT stimulated C-peptide(From screening to 12 months.)
- Change in Hemoglobin A1c (HbA1c)(From baseline to 12 months.)
- Change in time in glycemic target range(From screening to 12 months.)
- Change in time in range > 13.9 mmol/L(From screening to 12 months.)
- Change in time in range > 7.8 mmol/L(From screening to 12 months.)
- Change in glycemic variation(From screening to 12 months.)
- Variables that indicate effects on the immune system(From baseline to 12 months.)
研究者
研究点 (1)
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