Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE) (Protocol LUPSENIC)

Summary

Primary objectives : * To investigate the safety and the tolerability of ATO by IV infusions to patients with SLE, * To determine the maximum tolerated dose of ATO. Secondary objectives : * Evaluation of the clinical and biological response of the SLE to ATO, * Time of relapse in case of positive response, * Determination of the efficacy, * Pharmacokinetic study of ATO.

Timeline

Start

2013-07

Primary completion

2015-10

Completion

2015-10

Publications

• Hamidou M, Neel A, Poupon J, Amoura Z, Ebbo M, Sibilia J, Viallard JF, Gaborit B, Volteau C, Hardouin JB, Hachulla E, Rieger F. Safety and efficacy of low-dose intravenous arsenic trioxide in systemic lupus erythematosus: an open-label phase IIa trial (Lupsenic). Arthritis Res Ther. 2021 Mar 3;23(1):70. doi: 10.1186/s13075-021-02454-6.

Drugs

Indications