OBJECTIVE: Laquinimod is an oral therapeutic agent under investigation for the treatment of @entity30 ( @entity30 ), @entity2033 , @entity1988 and @entity15 . This dose escalation study evaluated the safety and efficacy of laquinimod as induction therapy in @entity1 with active moderate-severe @entity30 . DESIGN: Multicentre, double-blind, sequential-cohort, randomised controlled trial with laquinimod doses of 0.5, 1, 1.5 or 2   mg/day or placebo (n=45 per cohort randomised in a 2:1 ratio) for 8   weeks with 4-week follow-up. Stable concomittant therapies and prior use of anti- @entity5 necrosis factor agents were permitted. Comprehensive safety assessments were performed and efficacy analyses included the proportions of @entity1 in clinical remission ( @entity30 Activity Index (CDAI) <150 and no treatment failure (TF)), and with a clinical response (70 or 100 point CDAI reduction from baseline or remission and no TF). RESULTS: 117 @entity1 received laquinimod and 63 @entity1 received placebo. The overall incidence of adverse events (AEs) in the laquinimod group was similar to the pooled placebo group (86.2%-96.7% vs 82.5%) and most AEs were mild to moderate in severity. Treatment with laquinimod 0.5   mg showed consistent effects on remission (48.3% (CI 31% to 66%) vs 15.9% (CI 9% to 27%)), response 100 (55.2% (CI 37% to 71%) vs 31.7% (CI 22% to 44%)) and response 70 (62.1% (CI 44% to 77%) vs 34.9% (CI 24% to 47%)) versus placebo. Laquinimod 1.0   mg showed less benefit (26.7% remission (CI 14% to 44%) and 53.3% response 70 (CI 36% to 70%)), and no effect was noted on remission/response at higher doses. CONCLUSIONS: @entity20084 was safe and well tolerated, and the effects on remission and response of the 0.5   mg dose suggest a treatment benefit in @entity1 with @entity30 . TRIAL REGISTRATION NUMBER: NCT00737932.

A phase II study of laquinimod in XXXX .

@entity1 :: ('9606', 'Species') :: ['patients'] @entity20084 :: ('MESH:C476223', 'Chemical') :: ['Laquinimod'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumour'] @entity2033 :: ('MESH:D006816', 'Disease') :: ["Huntington's disease"] @entity1988 :: ('MESH:D008181', 'Disease') :: ['lupus nephritis'] @entity15 :: ('MESH:D009103', 'Disease') :: ['multiple sclerosis'] @entity30 :: ('MESH:D003424', 'Disease') :: ['CD', "Crohn's disease"]
@entity30 :: (MESH:D003424,Disease) :: ['Crohn's disease']
