Actively Recruiting
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-06-27
24
Participants Needed
1
Research Sites
291 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
I
Iltoo Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
Type 1 diabetes (T1D) is caused by the destruction of insulin-producing cells by effector T cells (Teffs), due to a deficiency of regulatory T cells (Tregs). Ciclosporin effectively blocks the Teffs and controls diabetes, but cannot be considered as a long-term treatment. Low-dose interleukin-2 (ld IL-2) activates and expands Tregs in humans. Hence, Ld IL-2 in patients in whom the autoimmune process was blocked early by a short treatment (2 months) of cyclosporine should restore immune homeostasis and maintain some insulin production over the long term.
CONDITIONS
Official Title
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 16 and 45 years (Tanner stage 5 pubertal)
- Type 1 diabetes diagnosed according to ADA criteria with at least one positive autoantibody (anti-islet, anti-GAD, anti-IA2, anti-ZnT8, or anti-insulin)
- Diagnosis made within the last 3 months
- No acid ketosis
- No weight loss greater than 10% or fasting C-peptide ≥ 0.1 nmol/L after at least 15 days of insulin therapy
- No significant abnormalities in blood tests including hematological, biochemical, liver, kidney, and thyroid function
- No history of heart disease, no family history of sudden death, and normal ECG
- Effective contraception used by men and women of childbearing potential for at least 2 weeks before first drug administration and throughout treatment
- Signed informed consent obtained prior to any trial examinations
You will not qualify if you...
- Allergy or hypersensitivity to IL-2 or its components
- Active infection requiring antibiotics
- History of clinical autoimmune diseases
- Oxygen saturation ≤ 90%
- Serious dysfunction of vital organs
- History of organ transplant
- Contraindications to ciclosporin
- Use of unauthorized treatments affecting blood glucose or interacting with trial drugs
- Use of non-insulin anti-diabetic treatment for more than 3 consecutive months
- Positive anti-thyroperoxidase with abnormal thyroid tests at inclusion
- Positive anti-transglutaminase at inclusion
- High viral loads of EBV (> 2000 IU/ml) or CMV (> 400 IU/ml)
- Infection with HBV, HCV, or HIV
- Lymphopenia ≤ 1000/mm3
- Cancer history cured less than 5 years ago (except early-stage cervical or basal cell carcinoma)
- Participation in other human intervention research within last 3 months
- Pregnant or breastfeeding women
- No social security coverage
- Vaccination with live virus in the 4 weeks before or during treatment
- Active COVID-19 infection
- Chronic respiratory disease
- Under legal protection or unable to consent
- Hospitalized without consent or deprived of liberty
AI-Screening
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Trial Site Locations
Total: 1 location
1
Lorenzon Roberta
Paris, France, 75013
Actively Recruiting
Research Team
D
David Klatzmann, MD, Ph.D
CONTACT
R
Roberta Lorenzon, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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