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

NCT04133233 | Completed Phase 2 DMC

• 3 other identifiers: D201806172018-002777-22MEDAECNAT-2018-10-00069
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Bipolar Depression

Keywords

Low dose of IL-2; Treg response

Outcome Measures

Primary Outcomes (1)

• change of Treg response

  Percentage Treg fold increase compared to baseline at Day 5

  baseline to Day 5

Secondary Outcomes (3)

• Treg response, under ld-IL2 in relation with symptomatic assessment of mood improvements

  from baseline to week 6

• changes in immune homeostasis under ld-IL2 in relation with symptomatic assessment of mood improvements

  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

  baseline to Day 60

Study Arms (2)

active treatment

EXPERIMENTAL

IL-2 (ILT-101) Sub-cutaneous 1 million UI/j

Drug: ILT101

placebo

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

ILT101 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)

Also known as: IL2

active treatment

Placebos 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)

Also known as: placebo

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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;

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Iltoo Pharma: collaborator

Study Sites (1)

Pr Marion Leboyer

Créteil, Hôpital Albert Chenevier, 94010, France

Location

Related Publications (2)

• 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.

  PMID: 39242054 DERIVED

• 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.

  PMID: 38367846 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Marion Leboyer, Pr

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: October 21, 2019
• Study Start: June 15, 2020
• Primary Completion: May 20, 2022
• Study Completion: July 20, 2022
• Last Updated: August 8, 2023

Record last verified: 2023-08

Locations

FR (1)