2024-514043-29-00招募中2 期
DFIL2-REP - Study of the clinical and biological response to repeated administration of low-dose interleukin-2 in patients with type 1 diabetes who have retained residual insulin secretion
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Variation in Tregs values at D70 compared with post-ciclosporin values (D63)
研究概览
简要总结
Evaluation of the Tregs lymphocyte response profile between D63 and D70, after 5 administrations of low-dose IL-2 (1MUI/day) in patients with type 1 diabetes of recent onset who had received ciclosporin treatment for 2 months.
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age at inclusion between ≥ 16 years (Tanner 5 pubertal stage) and ≤ 45 years
- •Type 1 diabetes according to ADA criteria, with at least 1 positive autoantibody (AAC) among the following AACs: anti-islet, anti-GAD, anti-IA2, anti-ZnT8 and anti-insulin
- •Diabetes stage 3 ≤ 3 months and without ketoacidosis and without weight loss > 10% OR with fasting C-peptide ≥ 0.1nmol/L (after a delay ≥ 15days following initiation of insulin therapy).
- •Absence of clinically significant biological abnormalities in hematology, biochemistry, liver, kidney and thyroid function tests
- •No documented history of heart disease and ECG without clinically significant abnormalities
- •Effective contraception for men and women of childbearing age > 2 weeks before the first administration of the investigational drug and throughout the treatment period (if sexually active). Sexually active women of childbearing age must use an effective contraceptive method. The following methods are acceptable: oral, injectable or implanted hormonal contraceptives. The minipill and copper IUD are tolerated28
- •Free, informed and written consent, signed by the patient and the investigator, before any examination required by the trial. If the patient is a minor, the signatures of the 2 parents and the child will be collected (or the legal representative if only one parent is alive).
排除标准
- •Known contraindications to IL-2 therapy
- •Lymphopenia ≤ 1000/ mm3
- •Presence or history of cancer cured within the last five years, except in situ cervical cancer or basal cell cancer managed at an early stage
- •Participation in other research relating to a clinical trial of a medicinal product for human use< 3 months
- •Pregnant or breast-feeding women
- •No social security coverage (as beneficiary or beneficiary's beneficiary)
- •Vaccination with live attenuated virus in the last 4 weeks before starting experimental treatment and throughout the treatment phase
- •Patient with active SARS-CoV-2 infection
- •Patients with chronic respiratory disease
- •Subject under legal protection (such as guardianship, curatorship or safeguarding)
- •Subject hospitalized without consent, unable to express consent or deprived of liberty
- •Known contraindications to ciclosporin treatment
- •Presence of unauthorized treatments, i.e. cytotoxics, products known to have an impact on glycemia or to interact with trial treatments
- •Patients who have received anti-diabetic treatment other than insulin for more than 3 consecutive months
- •Positivity of at least one thyroid-specific antibody (anti-TPO, anti-TG or anti-TRAKS) associated with an abnormal thyroid workup (TSH, T3, or T4) at inclusion
- •Anti-transglutaminase positive at inclusion
- •EBV viral load > 2000 IU/ml
- •CMV viral load > 400 IU/ml
- •HBV, HCV or HIV infection
结局指标
主要结局
Variation in Tregs values at D70 compared with post-ciclosporin values (D63)
Variation in Tregs values at D70 compared with post-ciclosporin values (D63)
次要结局
- Compliance with ciclosporin and ILT-101/placebo
- Tolerance: tolerance will be assessed from D1 to D719 by means of a clinical examination, measurement of vital signs, a systematic biological check-up and collection of adverse events at every visit.
- Evolution of residual insulin secretion
- Change in Tregs values at M3 (J88), M6 (J179), M9 (J270), M12 (J361) and after treatment discontinuation at M18 (J536) and M24 (J719) compared to baseline and post-ciclosporin values (J63)
研究者
Pr David Klatzmann
Scientific
Assistance Publique Hopitaux De Paris
研究点 (1)
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