ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)

Phase 2 Completed 100 enrolled Iltoo Pharma

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of ILT-101 (human recombinant interleukin 2 (IL-2)) in patients with moderate to severe systemic lupus erythematosus.

Timeline

Start: 2017-01-18
Primary completion: 2018-08-27
Completion: 2019-02-11

Outcome

Missed primary endpoint

paper The primary end point was not met in the intention-to-treat population PMID 35973803 ↗

paper (ILT-101: 68%, placebo: 58%; p=0.3439) PMID 35973803 ↗

Publications

Humrich JY, Cacoub P, Rosenzwajg M, Pitoiset F, Pham HP, Guidoux J, Leroux D, Vazquez T, Riemekasten G, Smolen JS, Tsokos G, Klatzmann D. Low-dose interleukin-2 therapy in active systemic lupus erythematosus (LUPIL-2): a multicentre, double-blind, randomised and placebo-controlled phase II trial. Ann Rheum Dis. 2022 Dec;81(12):1685-1694. doi: 10.1136/ard-2022-222501. Epub 2022 Aug 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	aldesleukin	Protein / enzyme biologic	1.5e+06 iu	Subcutaneous