Study Of SB-683699 Compared To Placebo In Subjects With Relapsing-Remitting Multiple Sclerosis (MS)

Phase 2 Completed 343 enrolled GlaxoSmithKline

RandomizedParallel-groupTriple-blindTreatment

Summary

SB-683699 is an oral medication that is thought to reduce the number of active white blood cells entering the brain; these white blood cells are part of the disease process for MS. This study will look at whether different doses of SB-683699 are effective and safe in patients with relapsing remitting MS.

Timeline

Start: 2006-12
Primary completion: 2009-08
Completion: 2010-08

Outcome

Met primary endpoint

paper A 49% reduction (95% CI 21·2-67·6; p=0·0026) in the cumulative number of new gadolinium-enhancing lesions was seen PMID 22226929 ↗

Publications

Miller DH, Weber T, Grove R, Wardell C, Horrigan J, Graff O, Atkinson G, Dua P, Yousry T, Macmanus D, Montalban X. Firategrast for relapsing remitting multiple sclerosis: a phase 2, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2012 Feb;11(2):131-9. doi: 10.1016/S1474-4422(11)70299-X. Epub 2012 Jan 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Firategrast	Small molecule	150 mg	Oral
Subject	Firategrast	Small molecule	600 mg	Oral
Subject	Firategrast	Small molecule	900 mg	Oral
Subject	Firategrast	Small molecule	1200 mg	Oral