Overview

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

Status:
Recruiting
Trial end date:
2022-08-15
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
Iltoo Pharma
Treatments:
Interleukin-2
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

- 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.