Back to resultsLow Dose IL-2 Therapy in Patients With a Depressive Episode in the Course of a Bipolar Disorder (DEPIL-2)
Primary Purpose
Bipolar Depression
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
ILT101
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Depression focused on measuring Low dose of IL-2, Treg response
Eligibility Criteria
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.
Sites / Locations
- Pr Marion Leboyer
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
active treatment
placebo
Arm Description
IL-2 (ILT-101) Sub-cutaneous 1 million UI/j
placebo Sub-cutaneous The Placebo used is a sterile powder that will be produced by the CMO (AMATSI, France).
Outcomes
Primary Outcome Measures
change of Treg response
Percentage Treg fold increase compared to baseline at Day 5
Secondary Outcome Measures
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
changes in immune homeostasis under ld-IL2 in relation with symptomatic assessment of mood improvements
variation in Treg /CD4+ at different visit expressed as percentage of baseline value
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.
Full Information
NCT ID
NCT04133233
First Posted
September 17, 2019
Last Updated
August 7, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Iltoo Pharma
1. Study Identification
Unique Protocol Identification Number
NCT04133233
Brief Title
Low Dose IL-2 Therapy in Patients With a Depressive Episode in the Course of a Bipolar Disorder
Acronym
DEPIL-2
Official Title
Low Dose IL-2 Therapy in Patients With a Depressive Episode in the Course of a Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
May 20, 2022 (Actual)
Study Completion Date
July 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Iltoo Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
Keywords
Low dose of IL-2, Treg response
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active treatment
Arm Type
Experimental
Arm Description
IL-2 (ILT-101) Sub-cutaneous
1 million UI/j
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo Sub-cutaneous The Placebo used is a sterile powder that will be produced by the CMO (AMATSI, France).
Intervention Type
Drug
Intervention Name(s)
ILT101
Other Intervention Name(s)
IL2
Intervention Description
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
Intervention Name(s)
Placebos
Other Intervention Name(s)
placebo
Intervention Description
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)
Primary Outcome Measure Information:
Title
change of Treg response
Description
Percentage Treg fold increase compared to baseline at Day 5
Time Frame
baseline to Day 5
Secondary Outcome Measure Information:
Title
Treg response, under ld-IL2 in relation with symptomatic assessment of mood improvements
Description
Change in the value of Montgomery Asberg Depression Rating and in The inventory of depressive symptomatology
Time Frame
from baseline to week 6
Title
changes in immune homeostasis under ld-IL2 in relation with symptomatic assessment of mood improvements
Description
variation in Treg /CD4+ at different visit expressed as percentage of baseline value
Time Frame
between Day 5 and Day 60
Title
Assess the incidence of ld-IL2(safety and tolerability) in patients with a depressive episode in the course of a bipolar disorder
Description
Frequency and type of adverse events during the trial.
Time Frame
baseline to Day 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion Leboyer, Pr
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Chair
Facility Information:
Facility Name
Pr Marion Leboyer
City
Créteil
State/Province
Hôpital Albert Chenevier
ZIP/Postal Code
94010
Country
France
12. IPD Sharing Statement
Learn more about this trial
Low Dose IL-2 Therapy in Patients With a Depressive Episode in the Course of a Bipolar Disorder
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