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

April 3, 2026 updated by: Assistance Publique - Hôpitaux de Paris
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Hôpital Albert Chenevier
      • Créteil, Hôpital Albert Chenevier, France, 94010
        • Pr Marion Leboyer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of Treg response
Time Frame: baseline to Day 5
Percentage Treg fold increase compared to baseline at Day 5
baseline to Day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from baseline to week 6
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
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
Time Frame: baseline to Day 60
Frequency and type of adverse events during the trial.
baseline to Day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Iltoo Pharma

Investigators

  • Study Chair: Marion Leboyer, Pr, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Actual)

May 20, 2022

Study Completion (Actual)

May 21, 2022

Study Registration Dates

First Submitted

September 17, 2019

First Submitted That Met QC Criteria

October 18, 2019

First Posted (Actual)

October 21, 2019

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D20180617
  • 2018-002777-22 (EudraCT Number)
  • MEDAECNAT-2018-10-00069 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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