Baseline characteristics of patients enrolled in CONCERTO - a study of 0.6 and 1.2 mg/day oral laquinimod for relapsing-remitting multiple sclerosis (P7.216)

OBJECTIVE: CONCERTO is an ongoing, double-blind, Phase III study evaluating laquinimod efficacy, safety, and tolerability at daily doses of 0.6 mg and 1.2 mg compared with placebo in patients with relapsing-remitting multiple sclerosis (RRMS). The trial is powered to test the effect of both laquinimod doses against placebo on 3-month confirmed disability progression. BACKGROUND: Oral laquinimod 0.6 mg once daily was studied in two Phase III trials for RRMS. The primary endpoint of reduction of confirmed relapses was met in ALLEGRO but not BRAVO. However, both studies suggested that the more pronounced effect of laquinimod is on disability progression. A Phase II trial dose-response suggested an increase in laquinimod dose may be associated with greater efficacy. METHODS: Approximately 2100 RRMS patients will be randomized into three treatment arms: laquinimod 0.6 mg or 1.2 mg or placebo. Main inclusion criteria are: 18-55 years of age, Expanded Disability Status Scale (EDSS) scores of 0-5.5 and 蠅1 relapse in the 12 months before study. Study duration will range from a minimum of 15 to a maximum of 24 months. Secondary endpoints include percent brain volume change and time to first confirmed relapse. RESULTS: In the first 18 months of recruitment, 1710 patients from 29 countries were randomized. Women make up 68[percnt] of participants. Mean±SD age is 36.6±9.1 years, time since first RRMS symptom is 5.6±3.9 years, and baseline EDSS is 2.6±1.3. Mean numbers of relapses in the previous 1 and 2 years are 1.3 and 1.9, respectively. Thirty-nine percent of participants have baseline T1 gadolinium-enhancing lesions, and mean T2 lesion volume is 8616 mm3. Twenty-six percent of participants were previously treated with a disease-modifying therapy. CONCLUSIONS: The characteristics of this study population are similar to those included in previous laquinimod trials, except patients are slightly younger and have shorter disease duration.