Blisibimod was initially developed by Amgen, with Phase I trials demonstrating comparable safety between the blisibimod and placebo treatments.[1] It was subsequently acquired by Anthera Pharmaceuticals,[13] who in 2010 initiated a global Phase II study called PEARL-SC to investigate the efficacy, safety, and tolerability of blisibimod in subjects with systemic lupus erythematosus.[2][14] The PEARL-SC study, completed in April 2012, yielded data that has been published.[15] Blisibimod is currently being tested in a Phase 3 study, CHABLIS-SC1, for systemic lupus erythematosus, and a Phase 2 study, BRIGHT-SC, for IgA nephropathy.
12Fabris M, Grimaldi F, Villalta D, Picierno A, Fabro C, Bolzan M, etal. (January 2010). "BLyS and April serum levels in patients with autoimmune thyroid diseases". Autoimmunity Reviews. 9 (3): 165–169. doi:10.1016/j.autrev.2009.07.005. PMID19647102.
↑Navarra SV, Guzmán RM, Gallacher AE, Hall S, Levy RA, Jimenez RE, etal. (February 2011). "Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial". Lancet. 377 (9767): 721–731. doi:10.1016/S0140-6736(10)61354-2. PMID21296403. S2CID28952240.
↑Clinical trial number NCT01162681 for "PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus" at ClinicalTrials.gov
↑Furie RA, Leon G, Thomas M, Petri MA, Chu AD, Hislop C, etal. (September 2015). "A phase 2, randomised, placebo-controlled clinical trial of blisibimod, an inhibitor of B cell activating factor, in patients with moderate-to-severe systemic lupus erythematosus, the PEARL-SC study". Annals of the Rheumatic Diseases. 74 (9): 1667–1675. doi:10.1136/annrheumdis-2013-205144. PMID24748629. S2CID23122293.