Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004123-37 | EudraCT Number | ||
| MEDAECNAT-2018-11-0048 | Other Identifier | ANSM | |
| 2-17-33 | Other Identifier | CPP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Iltoo Pharma | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and the dose-response relationship of ILT-101 to blood Tregs.
In the healthy physiological state, there is homeostasis between regulatory T cells (Tregs) and effector T cells (Teffs) which is deregulated in autoimmune diseases (AID).
The existence of an AID indicates a lack of Tregs. Our team has discovered that low-dose interleukin-2 (ld-IL2) activates and specifically increases Tregs in humans and thus may improve AID. Exploiting this potential requires i) to better target the dose with the best benefit / risk ratio and also ii) to better understand the mechanism of action of this molecule through clinical trials of ld-IL2 in progress, including in type 1 diabetes, multiple sclerosis and systemic lupus erythematosus. During these clinical trials, a very thorough immunological follow-up is carried out in order to discover biomarkers of treatment efficacy. Exploitation of these results will benefit both the cross-analysis of the effects of IL-2 in these 3 diseases with distinct pathophysiologies, but also very importantly a comparison with the effects of ld-IL2 at the healthy volunteer. These analyzes should make it possible to define the most effective dose of IL-2.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose A | Experimental | ILT-101 |
|
| dose B | Experimental | ILT-101 |
|
| dose C | Experimental | ILT-101 |
|
| dose D | Experimental | ILT-101 |
|
| dose E | Experimental | ILT-101 |
|
| Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ILT101 | Drug | Subcutaneous injections starting with induction course with once-daily administration for 5 consecutive days, followed by maintenance course with once every weeks administration during three weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Variation of Tregs(in (expressed in % of CD4 and total) | from Day 1 to Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC corresponding to the évolution of residual values of tregs/CD4+ | Day 5 to Day 60 | |
| numbers of different circulating immune populations | baseline to Day 60 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Klatzmann, MD | Investigation Center in Biotherapy et immunology Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris l'hopital 75013 Paris | Principal Investigator |
| Roberta Lorenzon, MD | Clinical Investigation Center Paris Est Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Investigation Center Paris Est Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris | Paris | 75013 | France |
Not provided
| ID | Term |
|---|---|
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Subcutaneous injections starting with induction course with once-daily administration for 5 consecutive days, followed by maintenance course with once every weeks administration during three weeks |
|
| levels of serum cytokine(pg) |
| from baseline to Day 60 |
| levels of serum chemokine | from baseline to Day 60 |
| composition of the intestinal microbiota | from baseline to Day 60 |
| adverse events, anti IL-2 autoantibodies | from baseline to Day 60 |
| levels of serum anti-IL-2 autoantibodies | from baseline to Day 60 |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |