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

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

Timeline

Start

2020-06-15

Primary completion

2022-05-20

Completion

2022-05-21

Outcome

Met primary endpoint

paper The primary evaluation criterion was met, with IL-2LD expanding 1.17 [95 % CI 1.01-1.34] vs 1.01 [95 % CI 0.90-1.12] (p = 0.0421) PMID 39242054 ↗

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.
• 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.

Drugs

Indications