Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus

Summary

The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE)

Timeline

Start

2010-12

Primary completion

2015-05

Completion

2015-05

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo (Weekly Infusion) FAS vs Epratuzumab 1200 mg Every Other Week (FAS); p =0.175 NCT01262365 ↗

registry analysis (superiority test); Placebo (Weekly Infusion) FAS vs Epratuzumab 600 mg Per Week (FAS); p =0.442 NCT01262365 ↗

paper There was no statistically significant difference in the primary end point between the groups PMID 27598855 ↗

Publications

• Gottenberg JE, Dorner T, Bootsma H, Devauchelle-Pensec V, Bowman SJ, Mariette X, Bartz H, Oortgiesen M, Shock A, Koetse W, Galateanu C, Bongardt S, Wegener WA, Goldenberg DM, Meno-Tetang G, Kosutic G, Gordon C. Efficacy of Epratuzumab, an Anti-CD22 Monoclonal IgG Antibody, in Systemic Lupus Erythematosus Patients With Associated Sjogren's Syndrome: Post Hoc Analyses From the EMBODY Trials. Arthritis Rheumatol. 2018 May;70(5):763-773. doi: 10.1002/art.40425. Epub 2018 Apr 12.
• Clowse ME, Wallace DJ, Furie RA, Petri MA, Pike MC, Leszczynski P, Neuwelt CM, Hobbs K, Keiserman M, Duca L, Kalunian KC, Galateanu C, Bongardt S, Stach C, Beaudot C, Kilgallen B, Gordon C; EMBODY Investigator Group. Efficacy and Safety of Epratuzumab in Moderately to Severely Active Systemic Lupus Erythematosus: Results From Two Phase III Randomized, Double-Blind, Placebo-Controlled Trials. Arthritis Rheumatol. 2017 Feb;69(2):362-375. doi: 10.1002/art.39856.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Epratuzumab	Monoclonal antibody	600 mg	Other
Subject	Epratuzumab	Monoclonal antibody	1200 mg	Other

Indications