Low Dose IL-2 Therapy in Patients With a Depressive Episode in the Course of a Bipolar Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-15

Study Completion Date

2022-07-20

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Bipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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active treatment

IL-2 (ILT-101) Sub-cutaneous

1 million UI/j

Group Type EXPERIMENTAL

ILT101

Intervention Type 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)

placebo

placebo Sub-cutaneous The Placebo used is a sterile powder that will be produced by the CMO (AMATSI, France).

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type 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)

Interventions

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ILT101

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)

Intervention Type DRUG

Placebos

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)

Intervention Type DRUG

Other Intervention Names

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IL2 placebo

Eligibility Criteria

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Inclusion Criteria

* A depressive episode according to DSM-V criteria in the course of a bipolar disorder
* MADRS score \> 17
* Already on a mood stabilizer and/or antidepressant
* Patient with a normal or controlled thyroid function
* Male or female both using effective methods of contraception during treatment if sexually active.

Exclusion Criteria

* \- Contraindication to IL-101 therapy:
* Hypersensitivity to active substance or excipient;
* Active infection requiring antibiotics therapy;
* Organ failure (e.g., liver, kidney, lung and heart);
* Immunosuppressed patient
* Hepatotoxic, nephrotoxic, myelotoxic or cardiotoxic drugs
* Other chronic diseases
* Signs of active infection requiring treatment
* Previous history of organ transplantation
* Leukocytes \< 4000 / mm3, platelets \< 100 000 / mm3, Hemoglobin \< 10.0 g/dL or 6.2 mmol/L, red cell blood \< 3.5 T/L.
* Anti-TPO or anti-TG or anti-TRACKS positive at inclusion.
* Use of anti-inflammatory medication on a regular basis for a chronic inflammatory/autoimmune Disorder (NSAD, immunosuppressant IV-Ig based treatment);
* Ongoing fever \< 38
* uncontrolled diabetes type I or II;
* Existing cancer or history of cancer in the last 5 years (except skin epidermoid cancer or in-situ cervix cancer);
* Existing or planned pregnancy or lactation;
* Person under legal protection (1121-8 of CSP, Public Health Code
* Pregnant and parturient and Breast feeding women (1121-5 of CSP)
* legally detained person (1121-6 of CSP)
* hospitalisation without consent
* under the age of majority (1121-7of CSP)
* Immediate risk for suicidal behaviour (MADRS-item 10 \>2 or columbia \> 2 for suicide idea);
* Known HIV infection or clinically manifest Acquired Immune Deficiency Syndrome (AIDS), Parkinson's or Alzheimer's disease, or any other serious condition likely to interfere with the conduct of the trial;
* Participation to an interventional study concomitantly or within 30 days prior to this study, except in the cohorts studies aiming at the analysis of immuno-inflammatory biomarkers and/or brain imaging studies.
* Patients thought to be unreliable or incapable of complying with the requirements of the protocol;
* Patient is relative of, or staff directly reporting to the investigator;
* Patient is employee of the sponsor.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No