Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)

Summary

This study is to evaluate the efficacy and safety of atacicept compared to placebo in preventing new flares in subjects with systemic lupus erythematosus (SLE) and to confirm the optimal dose of atacicept for treatment of subjects with SLE and gain information on the effect of atacicept on markers specific to its mechanism of action (MoA) and their correlation to disease activity/progression. Study medication will be administered through subcutaneous (under the skin) injections, beginning with twice weekly injections for the first 4 weeks, followed by once weekly doses for 48 weeks. Following the last treatment, a safety follow-up period of 24 weeks will be conducted.

Timeline

Start

2008-01

Primary completion

2012-04

Completion

2012-10

Publications

• Pitsiu M, Yalkinoglu O, Farrell C, Girard P, Vazquez-Mateo C, Papasouliotis O. Population pharmacokinetics of atacicept in systemic lupus erythematosus: An analysis of three clinical trials. CPT Pharmacometrics Syst Pharmacol. 2023 Aug;12(8):1157-1169. doi: 10.1002/psp4.12982. Epub 2023 Jun 18.
• Eslami M, Willen D, Papasouliotis O, Schuepbach-Mallpell S, Willen L, Donze O, Yalkinoglu O, Schneider P. Kinetics of free and ligand-bound atacicept in human serum. Front Immunol. 2022 Dec 2;13:1035556. doi: 10.3389/fimmu.2022.1035556. eCollection 2022.
• Isenberg D, Gordon C, Licu D, Copt S, Rossi CP, Wofsy D. Efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe systemic lupus erythematosus (SLE): 52-week data (APRIL-SLE randomised trial). Ann Rheum Dis. 2015 Nov;74(11):2006-15. doi: 10.1136/annrheumdis-2013-205067. Epub 2014 Jun 20.

Drugs

Indications