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Bipolar DepressionPhase 2DEPIL-2NCT04133233

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

A Phase 2 study testing ILT101 in people with Bipolar Depression, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bipolar Depression
What is being tested?
ILT101
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
14 participants
Where
1 siteFrance
Study dates
15 Jun 2020to 21 May 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • - 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
Show all 27Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Pr Marion Leboyer

    Créteil, Hôpital Albert Chenevier, 94010

Other trials in France

About this study

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

Read the 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.

Being tested
ILT101, Placebos
Keywords
Low dose of IL-2, Treg response
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ILT101Drug

    Also called IL2

    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)

  • PlacebosDrug

    Also called placebo

    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)

Study groups in NCT04133233
Study groupRoleWhat they receive
active treatmentExperimentalIL-2 (ILT-101) Sub-cutaneous 1 million UI/j
Receives: Drug: ILT101
placeboPlacebo comparatorplacebo Sub-cutaneous The Placebo used is a sterile powder that will be produced by the CMO (AMATSI, France).
Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change of Treg response

    Percentage Treg fold increase compared to baseline at Day 5

    Measured: baseline to Day 5

Secondary outcomes (3)

  1. 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

    Measured: from baseline to week 6

  2. 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

    Measured: between Day 5 and Day 60

  3. 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.

    Measured: baseline to Day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2019
  2. Study start15 Jun 2020
  3. Primary completion20 May 2022
  4. Study completion21 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04133233
Sponsor's protocol ID
D20180617
Other IDs
2018-002777-22, MEDAECNAT-2018-10-00069, 2018
Acronym
DEPIL-2
Status last verified
Apr 2026
First submitted
17 Sep 2019
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39242054

  • 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.

    PubMed 38367846

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ILT101 in people with Bipolar Depression, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change of Treg response (time frame: baseline to Day 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04133233, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.

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