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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04133233
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
Iltoo Pharma
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Bipolar Depression Drug: ILT101 Drug: Placebos Phase 2

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low Dose IL-2 Therapy in Patients With a Depressive Episode in the Course of a Bipolar Disorder
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: active treatment

IL-2 (ILT-101) Sub-cutaneous

1 million UI/j

Drug: 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)
Other Name: IL2

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




Primary Outcome Measures :
  1. change of Treg response [ Time Frame: baseline to Day 5 ]
    Percentage Treg fold increase compared to baseline at Day 5


Secondary Outcome Measures :
  1. Treg response, under ld-IL2 in relation with symptomatic assessment of mood improvements [ Time Frame: from baseline to week 6 ]
    Change in the value of Montgomery Asberg Depression Rating and in The inventory of depressive symptomatology

  2. changes in immune homeostasis under ld-IL2 in relation with symptomatic assessment of mood improvements [ Time Frame: between Day 5 and Day 60 ]
    variation in Treg /CD4+ at different visit expressed as percentage of baseline value

  3. Assess the incidence of ld-IL2(safety and tolerability) in patients with a depressive episode in the course of a bipolar disorder [ Time Frame: baseline to Day 60 ]
    Frequency and type of adverse events during the trial.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A depressive episode according to DSM-V criteria in the course of a bipolar disorder
  • MADRS score > 17
  • hsCRP > 3
  • Already on a mood stabilizer and/or antidepressant
  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133233


Contacts
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Contact: Marion Leboyer, Pr 01 49 81 30 51 ext +33 marion.leboyer@inserm.fr
Contact: Jean-Romain Richard 01 49 81 31 31 jean-romain.richard@inserm.fr

Locations
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France
Pr Marion Leboyer
Créteil, Hôpital Albert Chenevier, France, 94010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Iltoo Pharma
Investigators
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Study Chair: Marion Leboyer, Pr Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04133233    
Other Study ID Numbers: D20180617
2018-002777-22 ( EudraCT Number )
MEDAECNAT-2018-10-00069 ( Other Identifier: ANSM )
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Low dose of IL-2
Treg response
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs