Type 1 DiabetesPhase 2DF-IL2-REPNCT05153070
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
A Phase 2 study testing Cyclosporin and ILT101 in people with Type 1 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Cyclosporin and ILT101
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2022to 29 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- • Age at inclusion between ≥ 16 years old (Tanner 5 pubertal stage) and ≤ 45 years old
- Type 1 diabetes according to ADA criteria, with at least 1 positive autoantibody among the following: anti-islet, anti-GAD, anti-IA2, anti-ZnT8 and anti-insulin.
- Diagnosis ≤ 3 months
- No acid ketosis
- No weight loss > 10% OR with fasting C-peptide ≥ 0.1 nmol/L (after a period of ≥ 15 days following the initiation of insulin therapy
- Absence of clinically significant biological abnormalities on hematological, biochemical, hepatic, renal and thyroid tests.
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- No documented history of heart disease, no family history of sudden death, AND normal ECG.
- Effective contraception in men and women of childbearing potential > 2 weeks prior to first administration of the investigational drug and throughout the treatment period (if sexually active). Specifically for women of childbearing age and sexually active, they must use an effective contraceptive method (Pearl Index < 1). The following methods are acceptable: oral hormonal contraceptives, injectable, or implanted (with the exception of oral minipills: i.e. low doses of gestagens which are not acceptable (lynestrenol and norestisteron), intrauterine contraceptives (e.g. progestin-release systems)),
- Free, informed and written consent, signed by the patient and the investigator, prior to any examination required by the trial.
- If the patient is a minor, the signatures of both parents and of the child will be collected (or the legal representative if only one parent is alive).
Who cannot join
- Known contraindications to IL2 treatment:
- Hypersensitivity to the active substance or to one of the excipients.
- Signs of active infection requiring antibiotics
- Documented history of clinical autoimmune disease
- Oxygen saturation ≤ 90%
- Existence of a serious dysfunction in a vital organ
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- History of organ allograft,
- Known contraindications to treatment with cyclosporine
- Presence of unauthorized treatment, i.e. cytotoxic drugs, products known for their impact on blood glucose levels or for their interactions with the treatments under trial
- Patients who have received anti-diabetic treatment other than insulin for more than 3 consecutive months.
- Anti-thyroperoxidase positive and abnormal TSH and 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
- Lymphopenia ≤ 1000/ mm3
- Presence or history of cancer that has been cured for less than five years, except in situ cervical or basal cell carcinoma in early stage management,
- Participation in other intervention research involving humans < 3 months,
- Pregnant or breastfeeding women
- Lack of social security affiliation (as a beneficiary or assignee)
- Vaccination with live attenuated virus during the last 4 weeks before the start of the experimental treatment and during the entire treatment phase.
- Patient with active SARS-CoV-2 infection
- Patient with chronic respiratory disease
- Subject under legal protection (such as tutorship, curatorship, or judicial safeguard)
- Subject hospitalized without consent, unable to express consent or deprived of liberty
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Lorenzon Roberta
Paris, 75013
Roberta Lorenzon, MD, roberta.lorenzon@sorbonne-universite.fr
About this study
Official title: Clinical and Biological Responses to Repeated Administration of Low-dose Interleukin-2 in Patients With Type 1 Diabetes and a Residual Insulin Secretion
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.
Read the detailed description
Primary Objective :
Tregs' response profile, after 4 administrations of 1MIU/day of IL-2 (Day 63-66) in patients with recently diagnosed type 1 diabetes who have been treated with ciclosporin for 2 months.
Primary assessment criterion:
Change in Tregs values at D67 compared to D63 (post-ciclosporin values)
Secondary objectives and secondary assessment criteria:
- Change in residual insulin secretion
- AUC plasma C-peptide concentration after a mixed meal tolerance test at Month 6 (Day 179), Month 12 (Day 361) and after treatment discontinuation at Month 18 (Day 536) and Month 24 (Day 719) compared to baseline;
- Insulin requirement, HbA1c dosage and IDAA1c score at Month 3 (Day 88), Month 6 (Day 179), Month 9 (Day 270), Month 12 (Day 361) and after treatment discontinuation at Month 18 (Day 536) and Month 24 (Day 719) compared to baseline
- Change in Tregs values at Month 3 (Day 88), Month 6 (Day 179), Month 9 (Day 270), Month 12 (Day 361) and after treatment discontinuation at Month 18 (Day 536) and Month 24 (Day 719) compared to baseline and post-ciclosporin values (Day 63)
- Ciclosporin and ILT-101/placebo compliance
- Tolerance
Experimental design:
This is a monocentric, randomized, placebo controlled, double-blind trial in parallel-groups, evaluating a treatment by cyclosporine 7mg/kg/day during 2 months followed by ILT-101/placebo, 1 MIU daily for 5 days and 1 MIU every week, during 10 months.
Population involved:
Male or female, aged between 16 and 35 years, with recent diagnosis of type 1 diabetes (< 3 months).
Number of subjects: 24 Inclusion period: 12 months Duration of patient participation: 24 months (treatment period: 12 months, follow-up period: 12months) Total duration of the study: 37 months
- Conditions
- Type 1 Diabetes
- Being tested
- Cyclosporin, ILT101, Placebo
- Keywords
- Interleukin 2, Ciclosporin, Auto-immune disease, Diabetes, Regulatory T cells, Immune tolerance, Immunotherapy
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclosporinDrug
- Ciclosporin: 5mg/kg, twice a day, oral, between Day 1 and Day 60
ILT101Drug
- ILT-101: 1MIU/day in a volume of 1 ml; subcutaneous injection every day during 5 consecutive days and then every week between Day 63 and Day 354.
PlaceboDrug
- Placebo with an identical formulation and regimen of injections i.e. Subcutaneous injection every day (5 consecutive days) then then every week between Day 63 and Day 354.
| Study group | Role | What they receive |
|---|---|---|
| Ciclosporin/ILT-101 | Experimental | Ciclosporin during 2 months (for all patients) followed by ILT-101 during 10 months Receives: Drug: Cyclosporin; Drug: ILT101 |
| Ciclosporin/placebo | Placebo comparator | Ciclosporin during 2 months (for all patients) followed by placebo during 10 months Receives: Drug: Cyclosporin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treg variation
Change in Tregs values at Day 67 compared to Day 63 (post-ciclosporin value)
Measured: From Day 63 to Day 67
Secondary outcomes (41)
Change in Area under curve (AUC (T0-T120) of serum C-peptide at month 6
Change in Area under curve (AUC (T0-T120) of serum C-peptide after mixed-meal tolerance test compared to baseline
- Variation in HbA1c value (in %) 3. Variation in IDAA1c score (IDAA1c score = HbA1c (in %) + [4 × insulin dose (in international units per kilogram per 24 h)].
- Change in Insulin requirement (insulin dose in international units per kilogram per 24 h 5. Change in Tregs values (in %/CD4+) at month 3, month 6, month 9, month 12 and after treatment interruption at month 18 and month 24 compared to baseline and post-cyclosporin values (Day 63)
Measured: up to month 6
Change in Area under curve (AUC (T0-T120) of serum C-peptide at month 12
Change in Area under curve (AUC (T0-T120) of serum C-peptide after mixed-meal tolerance test compared to baseline
- Variation in HbA1c value (in %) 3. Variation in IDAA1c score (IDAA1c score = HbA1c (in %) + [4 × insulin dose (in international units per kilogram per 24 h)].
- Change in Insulin requirement (insulin dose in international units per kilogram per 24 h 5. Change in Tregs values (in %/CD4+) at month 3, month 6, month 9, month 12 and after treatment interruption at month 18 and month 24 compared to baseline and post-cyclosporin values (Day 63)
Measured: up to month 12
Change in Area under curve (AUC (T0-T120) of serum C-peptide at month 24
Change in Area under curve (AUC (T0-T120) of serum C-peptide after mixed-meal tolerance test compared to baseline
- Variation in HbA1c value (in %) 3. Variation in IDAA1c score (IDAA1c score = HbA1c (in %) + [4 × insulin dose (in international units per kilogram per 24 h)].
- Change in Insulin requirement (insulin dose in international units per kilogram per 24 h 5. Change in Tregs values (in %/CD4+) at month 3, month 6, month 9, month 12 and after treatment interruption at month 18 and month 24 compared to baseline and post-cyclosporin values (Day 63)
Measured: up to month 24
Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to Baseline at day 63,
Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to baseline
Measured: up to day 63
Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to Baseline at month 3
Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to baseline
Measured: up to month 3
Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to Baseline at month 6
Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to baseline
Measured: up to month 6
Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to Baseline at month 9
Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to baseline
Measured: up to month 9
Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to Baseline at month 12
Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to baseline
Measured: up to month 12
Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to Baseline at month 18
Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to baseline
Measured: up to month 18
Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to Baseline at month 24
Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to baseline
Measured: up to month 24
Variation in IDAA1c scoreduring the treatment period and during the 1 year follow-up period at day 63
Variation in IDAA1c score (IDAA1c score = HbA1c (in %) + [4 × insulin dose (in international units per kilogram per 24 h)] during the treatment period and during the 1 year follow-up period compared to baseline
Measured: up to day 63
Variation in IDAA1c scoreduring the treatment period and during the 1 year follow-up period up to month 3
Variation in IDAA1c score (IDAA1c score = HbA1c (in %) + [4 × insulin dose (in international units per kilogram per 24 h)] during the treatment period and during the 1 year follow-up period compared to baseline
Measured: up to month 3
Variation in IDAA1c scoreduring the treatment period and during the 1 year follow-up period at month 6
Variation in IDAA1c score (IDAA1c score = HbA1c (in %) + [4 × insulin dose (in international units per kilogram per 24 h)] during the treatment period and during the 1 year follow-up period compared to baseline
Measured: up to month 6
Variation in IDAA1c scoreduring the treatment period and during the 1 year follow-up period at month 9
Variation in IDAA1c score (IDAA1c score = HbA1c (in %) + [4 × insulin dose (in international units per kilogram per 24 h)] during the treatment period and during the 1 year follow-up period compared to baseline
Measured: up to month 9
Variation in IDAA1c scoreduring the treatment period and during the 1 year follow-up period at month 12
Variation in IDAA1c score (IDAA1c score = HbA1c (in %) + [4 × insulin dose (in international units per kilogram per 24 h)] during the treatment period and during the 1 year follow-up period compared to baseline
Measured: up to month 12
Variation in IDAA1c scoreduring the treatment period and during the 1 year follow-up period at day month 18
Variation in IDAA1c score (IDAA1c score = HbA1c (in %) + [4 × insulin dose (in international units per kilogram per 24 h)] during the treatment period and during the 1 year follow-up period compared to baseline
Measured: up to month 18
Variation in IDAA1c scoreduring the treatment period and during the 1 year follow-up period at month 24
Variation in IDAA1c score (IDAA1c score = HbA1c (in %) + [4 × insulin dose (in international units per kilogram per 24 h)] during the treatment period and during the 1 year follow-up period compared to baseline
Measured: up to month 24
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at day 30
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period compared to baseline
Measured: up to day 30
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at day 63
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period compared to baseline
Measured: up to day 63
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at month 3
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period compared to baseline
Measured: up to month 3
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at month 6
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period compared to baseline
Measured: up to month 6
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at month 9
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period compared to baseline
Measured: up to month 9
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at month 12
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period compared to baseline
Measured: up to month 12
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at month 18
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period compared to baseline
Measured: up to month 18
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at month 24
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period compared to baseline
Measured: up to month 24
Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at day 30
Change in Tregs values (in %/CD4+) after treatment interruption compared to baseline and post-cyclosporin values
Measured: up to day 30
Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at day 63
Change in Tregs values (in %/CD4+) after treatment interruption compared to baseline and post-cyclosporin values
Measured: up to day 63
Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at month 3
Change in Tregs values (in %/CD4+) after treatment interruption compared to baseline and post-cyclosporin values
Measured: up to month 3
Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at month 6
Change in Tregs values (in %/CD4+) after treatment interruption compared to baseline and post-cyclosporin values
Measured: up to month 6
Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at month 9
Change in Tregs values (in %/CD4+) after treatment interruption compared to baseline and post-cyclosporin values
Measured: up to month 9
Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at month 12
Change in Tregs values (in %/CD4+) after treatment interruption compared to baseline and post-cyclosporin values
Measured: up to month 12
Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at month 18
Change in Tregs values (in %/CD4+) after treatment interruption compared to baseline and post-cyclosporin values
Measured: up to month 18
Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at month 24
Change in Tregs values (in %/CD4+) after treatment interruption compared to baseline and post-cyclosporin values
Measured: up to month 24
incidence of adverse events at day 30
incidence of adverse events throughout the study (according to NCI-CTC AE classification) to the Baseline to month 24
Measured: up to day 30
incidence of adverse events at day 63
incidence of adverse events throughout the study (according to NCI-CTC AE classification) to the Baseline to month 24
Measured: up to day 63
incidence of adverse events at month 3
incidence of adverse events throughout the study (according to NCI-CTC AE classification) to the Baseline to month 24
Measured: up to month 3
incidence of adverse events at month 6
incidence of adverse events throughout the study (according to NCI-CTC AE classification) to the Baseline to month 24
Measured: up to month 6
incidence of adverse events at month 9
incidence of adverse events throughout the study (according to NCI-CTC AE classification) to the Baseline to month 24
Measured: up to month 9
incidence of adverse events at month 12
incidence of adverse events throughout the study (according to NCI-CTC AE classification) to the Baseline to month 24
Measured: up to month 12
incidence of adverse events at month 18
incidence of adverse events throughout the study (according to NCI-CTC AE classification) to the Baseline to month 24
Measured: up to month 18
incidence of adverse events at month 24
incidence of adverse events throughout the study (according to NCI-CTC AE classification) to the Baseline to month 24
Measured: up to month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start21 Sep 2022
- Primary completion29 Nov 2027 (estimated)
- Study completion29 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single group during ciclosporin treatment and parallel group during ILT-101 treatment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Iltoo Pharma
- Responsible party
- Sponsor
- Investigators
- David Klatzmann, MD, Ph.D, Study director, APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARISAgnès Hartmann, MD, Ph.D, Principal investigator, APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153070
- Sponsor's protocol ID
- P120142
- Acronym
- DF-IL2-REP
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2021
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biological Responses to Repeated Administration of Low-dose Interleukin-2 in Patients With Type 1 Diabetes and a Residual Insulin Secretion
- ClinicalTrials.gov ID
- NCT05153070
- Acronym / sponsor ID
- DF-IL2-REP / P120142
- Conditions
- Type 1 Diabetes
- Keywords
- Interleukin 2, Ciclosporin, Auto-immune disease, Diabetes, Regulatory T cells, Immune tolerance, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Iltoo Pharma
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 29 Nov 2027 (estimated)
- Study completion
- 29 Nov 2027 (estimated)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective :
Tregs' response profile, after 4 administrations of 1MIU/day of IL-2 (Day 63-66) in patients with recently diagnosed type 1 diabetes who have been treated with ciclosporin for 2 months.
Primary assessment criterion:
Change in Tregs values at D67 compared to D63 (post-ciclosporin values)
Secondary objectives and secondary assessment criteria:
- Change in residual insulin secretion
- AUC plasma C-peptide concentration after a mixed meal tolerance test at Month 6 (Day 179), Month 12 (Day 361) and after treatment discontinuation at Month 18 (Day 536) and Month 24 (Day 719) compared to baseline;
- Insulin requirement, HbA1c dosage and IDAA1c score at Month 3 (Day 88), Month 6 (Day 179), Month 9 (Day 270), Month 12 (Day 361) and after treatment discontinuation at Month 18 (Day 536) and Month 24 (Day 719) compared to baseline
- Change in Tregs values at Month 3 (Day 88), Month 6 (Day 179), Month 9 (Day 270), Month 12 (Day 361) and after treatment discontinuation at Month 18 (Day 536) and Month 24 (Day 719) compared to baseline and post-ciclosporin values (Day 63)
- Ciclosporin and ILT-101/placebo compliance
- Tolerance
Experimental design:
This is a monocentric, randomized, placebo controlled, double-blind trial in parallel-groups, evaluating a treatment by cyclosporine 7mg/kg/day during 2 months followed by ILT-101/placebo, 1 MIU daily for 5 days and 1 MIU every week, during 10 months.
Population involved:
Male or female, aged between 16 and 35 years, with recent diagnosis of type 1 diabetes (< 3 months).
Number of subjects: 24 Inclusion period: 12 months Duration of patient participation: 24 months (treatment period: 12 months, follow-up period: 12months) Total duration of the study: 37 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Single group during ciclosporin treatment and parallel group during ILT-101 treatment
| Arm | Type | Receives |
|---|---|---|
| Ciclosporin/ILT-101 | Experimental | Drug: Cyclosporin, Drug: ILT101Ciclosporin during 2 months (for all patients) followed by ILT-101 during 10 months |
| Ciclosporin/placebo | Placebo comparator | Drug: Cyclosporin, Drug: PlaceboCiclosporin during 2 months (for all patients) followed by placebo during 10 months |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- • Age at inclusion between ≥ 16 years old (Tanner 5 pubertal stage) and ≤ 45 years old
- If the patient is a minor, the signatures of both parents and of the child will be collected (or the legal representative if only one parent is alive).
Key exclusion criteria (25 listed)
- Known contraindications to IL2 treatment:
- Known contraindications to treatment with cyclosporine
- Presence of unauthorized treatment, i.e. cytotoxic drugs, products known for their impact on blood glucose levels or for their interactions with the treatments under trial
- Patients who have received anti-diabetic treatment other than insulin for more than 3 consecutive months.
- Anti-thyroperoxidase positive and abnormal TSH and T4 at inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclosporin• Ciclosporin: 5mg/kg, twice a day, oral, between Day 1 and Day 60 | Drug | Ciclosporin/ILT-101, Ciclosporin/placebo |
| ILT101• ILT-101: 1MIU/day in a volume of 1 ml; subcutaneous injection every day during 5 consecutive days and then every week between Day 63 and Day 354. | Drug | Ciclosporin/ILT-101 |
| Placebo• Placebo with an identical formulation and regimen of injections i.e. Subcutaneous injection every day (5 consecutive days) then then every week between Day 63 and Day 354. | Drug | Ciclosporin/placebo |
Primary outcome
Treg variation
Time frame: From Day 63 to Day 67
Change in Tregs values at Day 67 compared to Day 63 (post-ciclosporin value)
41 secondary outcomes
Change in Area under curve (AUC (T0-T120) of serum C-peptide at month 6
Time frame: up to month 6
Change in Area under curve (AUC (T0-T120) of serum C-peptide at month 12
Time frame: up to month 12
Change in Area under curve (AUC (T0-T120) of serum C-peptide at month 24
Time frame: up to month 24
Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to Baseline at day 63,
Time frame: up to day 63
Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to Baseline at month 3
Time frame: up to month 3
Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to Baseline at month 6
Time frame: up to month 6
Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to Baseline at month 9
Time frame: up to month 9
Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to Baseline at month 12
Time frame: up to month 12
Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to Baseline at month 18
Time frame: up to month 18
Variation in HbA1c value (in %) during the treatment period and during the 1-year follow-up period compared to Baseline at month 24
Time frame: up to month 24
Variation in IDAA1c scoreduring the treatment period and during the 1 year follow-up period at day 63
Time frame: up to day 63
Variation in IDAA1c scoreduring the treatment period and during the 1 year follow-up period up to month 3
Time frame: up to month 3
Variation in IDAA1c scoreduring the treatment period and during the 1 year follow-up period at month 6
Time frame: up to month 6
Variation in IDAA1c scoreduring the treatment period and during the 1 year follow-up period at month 9
Time frame: up to month 9
Variation in IDAA1c scoreduring the treatment period and during the 1 year follow-up period at month 12
Time frame: up to month 12
Variation in IDAA1c scoreduring the treatment period and during the 1 year follow-up period at day month 18
Time frame: up to month 18
Variation in IDAA1c scoreduring the treatment period and during the 1 year follow-up period at month 24
Time frame: up to month 24
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at day 30
Time frame: up to day 30
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at day 63
Time frame: up to day 63
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at month 3
Time frame: up to month 3
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at month 6
Time frame: up to month 6
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at month 9
Time frame: up to month 9
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at month 12
Time frame: up to month 12
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at month 18
Time frame: up to month 18
Change in Insulin requirement (insulin dose in international units per kilogram per 24 h) during the treatment period and during the 1 year follow-up period at month 24
Time frame: up to month 24
Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at day 30
Time frame: up to day 30
Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at day 63
Time frame: up to day 63
Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at month 3
Time frame: up to month 3
Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at month 6
Time frame: up to month 6
Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at month 9
Time frame: up to month 9
Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at month 12
Time frame: up to month 12
Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at month 18
Time frame: up to month 18
Change in Tregs values (in %/CD4+) after treatment interruption and post-cyclosporin values at month 24
Time frame: up to month 24
incidence of adverse events at day 30
Time frame: up to day 30
incidence of adverse events at day 63
Time frame: up to day 63
incidence of adverse events at month 3
Time frame: up to month 3
incidence of adverse events at month 6
Time frame: up to month 6
incidence of adverse events at month 9
Time frame: up to month 9
incidence of adverse events at month 12
Time frame: up to month 12
incidence of adverse events at month 18
Time frame: up to month 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Klatzmann, MD, Ph.D study director
APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS
Agnès Hartmann, MD, Ph.D principal investigator
APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclosporin and ILT101 in people with Type 1 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Klatzmann, MD, Ph.D (01 42 17 74 61 ext. +33, david.klatzmann@sorbonne-universite.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treg variation (time frame: From Day 63 to Day 67). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.