ALDESLEUKIN for Type 1 diabetes

Inclusion criteria

• {"criterion_text":"- Age at inclusion between ≥ 16 years (Tanner 5 pubertal stage) and ≤ 45 years"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- Absence of clinically significant biological abnormalities in hematology, biochemistry, liver, kidney and thyroid function tests"}
• {"criterion_text":"- No documented history of heart disease and ECG without clinically significant abnormalities"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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)."}

Exclusion criteria

• {"criterion_text":"- Known contraindications to IL-2 therapy"}
• {"criterion_text":"- Lymphopenia ≤ 1000/ mm3"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Participation in other research relating to a clinical trial of a medicinal product for human use< 3 months"}
• {"criterion_text":"- Pregnant or breast-feeding women"}
• {"criterion_text":"- No social security coverage (as beneficiary or beneficiary's beneficiary)"}
• {"criterion_text":"- Vaccination with live attenuated virus in the last 4 weeks before starting experimental treatment and throughout the treatment phase"}
• {"criterion_text":"- Patient with active SARS-CoV-2 infection"}
• {"criterion_text":"- Patients with chronic respiratory disease"}
• {"criterion_text":"- Subject under legal protection (such as guardianship, curatorship or safeguarding)"}
• {"criterion_text":"- Subject hospitalized without consent, unable to express consent or deprived of liberty"}
• {"criterion_text":"- Known contraindications to ciclosporin treatment"}
• {"criterion_text":"- Presence of unauthorized treatments, i.e. cytotoxics, products known to have an impact on glycemia or to interact with trial treatments"}
• {"criterion_text":"- Patients who have received anti-diabetic treatment other than insulin for more than 3 consecutive months"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Anti-transglutaminase positive at inclusion"}
• {"criterion_text":"- EBV viral load > 2000 IU/ml"}
• {"criterion_text":"- CMV viral load > 400 IU/ml"}
• {"criterion_text":"- HBV, HCV or HIV infection"}

Primary endpoints

• {"endpoint_text":"- Variation in Tregs values at D70 compared with post-ciclosporin values (D63)","definition_or_measurement_approach":"Comparison of Tregs values at Day 70 versus post-ciclosporin values at Day 63"}

Secondary endpoints

• {"endpoint_text":"- Compliance with ciclosporin and ILT-101/placebo","definition_or_measurement_approach":""}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Assessed from Day 1 to Day 719 by clinical examination, vital signs, systematic biological tests and collection of adverse events at every visit"}
• {"endpoint_text":"- Evolution of residual insulin secretion","definition_or_measurement_approach":""}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Serial measurement of Tregs at specified timepoints (J88, J179, J270, J361, J536, J719) compared to baseline and post-ciclosporin (J63)"}

France

Earliest CTIS Part Ii Submission Date

30-05-2024

Latest Decision Or Authorization Date

06-02-2025

Processing Time Days

252

Number Of Sites

4

Number Of Participants

24

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France