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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002777-22 | EudraCT Number | ||
| MEDAECNAT-2018-10-00069 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Iltoo Pharma | INDUSTRY |
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The purpose of this study will be to demonstrate improvement of the T regulatory cells (Treg) response, under add on low-dose Interleukin 2 (ld-IL2) in patients with bipolar disorders experiencing a depressive relapse
A hypothesis still under study concerning the pathophysiological mechanisms of bipolar disorder concerns an immunological disorder that could possibly be involved in this disease and during a depressive episode. In particular, that the multiplication of a certain category of white blood cells called "regulators" that block the toxic effect of more aggressive white blood cells could improve these disorders.
The aim of this research is therefore to check the effectiveness and safety of injections of Interleukin 2 (IL-2) to induce this multiplication of regulatory white blood cells.
IL-2 is a natural protein released by white blood cells that is used for the proper functioning of the immune defence system. The favourable effects of injecting small doses of IL-2 are known and assessed in other diseases, including autoimmune diseases.
The secondary objective of this study is to assess the effect of these injections on patient's mood, which could be improved by this treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active treatment | Experimental | IL-2 (ILT-101) Sub-cutaneous 1 million UI/j |
|
| placebo | Placebo Comparator | placebo Sub-cutaneous The Placebo used is a sterile powder that will be produced by the CMO (AMATSI, France). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ILT101 | Drug | Treatment administration consists in a first course of five-day treatment (induction), followed by a single injection every week for 4 weeks (maintenance; from Week 3 to Week 6) |
| Measure | Description | Time Frame |
|---|---|---|
| change of Treg response | Percentage Treg fold increase compared to baseline at Day 5 | baseline to Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Treg response, under ld-IL2 in relation with symptomatic assessment of mood improvements | Change in the value of Montgomery Asberg Depression Rating and in The inventory of depressive symptomatology | from baseline to week 6 |
| changes in immune homeostasis under ld-IL2 in relation with symptomatic assessment of mood improvements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marion Leboyer, Pr | Assistance Publique - Hôpitaux de Paris | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pr Marion Leboyer | Créteil | Hôpital Albert Chenevier | 94010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39242054 | Derived | Leboyer M, Foiselle M, Tchitchek N, Tamouza R, Lorenzon R, Richard JR, Arrouasse R, Le Corvoisier P, Le Dudal K, Vicaut E, Ellul P, Rosenzwajg M, Klatzmann D. Low-dose interleukin-2 in patients with bipolar depression: A phase 2 randomised double-blind placebo-controlled trial. Brain Behav Immun. 2025 Jan;123:177-184. doi: 10.1016/j.bbi.2024.09.005. Epub 2024 Sep 4. | |
| 38367846 |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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Randomized, double-blind, placebo-controlled (2 active: 1 placebo), multicentre, 6-week, proof-of concept trial of add on low dose IL-2 therapy in patients with a depressive episode in the course of a bipolar disorder, hospitalized or not. The study will be an add-on study, with no wash-out period.
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| Placebos | Drug | Treatment administration consists in a first course of five-day treatment (induction), followed by a single injection every week for 4 weeks (maintenance; from Week 3 to Week 6) |
|
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variation in Treg /CD4+ at different visit expressed as percentage of baseline value |
| between Day 5 and Day 60 |
| Assess the incidence of ld-IL2(safety and tolerability) in patients with a depressive episode in the course of a bipolar disorder | Frequency and type of adverse events during the trial. | baseline to Day 60 |
| Poletti S, Zanardi R, Mandelli A, Aggio V, Finardi A, Lorenzi C, Borsellino G, Carminati M, Manfredi E, Tomasi E, Spadini S, Colombo C, Drexhage HA, Furlan R, Benedetti F. Low-dose interleukin 2 antidepressant potentiation in unipolar and bipolar depression: Safety, efficacy, and immunological biomarkers. Brain Behav Immun. 2024 May;118:52-68. doi: 10.1016/j.bbi.2024.02.019. Epub 2024 Feb 15. |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |