Date: 2015-04-23
Type of information: Recruitment of the first patient
phase: 2
Announcement: recruitment of the first patient
Company: Teva Pharmaceutical Industries (Israel) Active Biotech (Sweden)
Product: laquinimod
Action
mechanism: immunomodulator. Laquinimod is a once-daily oral, investigational, CNS-active immunomodulator with a novel mechanism of action being developed for the treatment of relapsing-remitting MS (RRMS), progressive MS and Huntington’s disease. The global, Phase III, clinical development program evaluating laquinimod in MS includes two completed pivotal studies, ALLEGRO and BRAVO (both 0.6mg/day). A third Phase III trial, CONCERTO, is currently ongoing and evaluating two doses of laquinimod (0.6mg and 1.2mg/day) in approximately 2,100 patients for up to 24 months. The primary outcome measure is time to three-month confirmed-disability progression as measured by the Expanded Disability Status Scale (EDSS).
Disease: primary progressive multiple sclerosis
Therapeutic area: Autoimmune diseases - Neurodegenerative diseases
Country: Canada, Germany, Italy, The Netherlands, Poland, Russian Federation, Spain, Ukraine, UK, USA
Trial
details: ARPEGGIO is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study of once-daily, oral laquinimod (0.6mg or 1.5mg/day) in patients with primary progressive multiple sclerosis. This Phase 2 study is intended to serve as a proof of concept for potential treatment with laquinimod in patients with PPMS. The study is also aimed at evaluating 2 doses of laquinimod in this population.The study's primary endpoint is percent brain volume change (PBVC) through MRI analysis. The trial will enroll approximately 375 patients in the U.S., Canada, and Europe. (NCT02284568)
Latest
news: * On April 23, 2015, Teva Pharmaceutical Industries and Active Biotech announced the first patient has been enrolled in the study A Randomized Placebo-controlled Trial Evaluating Laquinimod in PPMS, Gauging Gradations In MRI and Clinical Outcomes (ARPEGGIO), a Phase II study to evaluate laquinimod, an investigational, oral, immune modulator, for the treatment of primary progressive multiple sclerosis (PPMS). * On November 4, 2014, Teva Pharmaceutical Industries and Active Biotech announced the expansion of the laquinimod clinical development program with the initiation of the ARPEGGIO trial, which will evaluate the potential of laquinimod to treat primary progressive multiple sclerosis (PPMS). The ARPEGGIO study will evaluate the efficacy, safety and tolerability of laquinimod in patients with PPMS with a primary endpoint of percent brain volume change (PBVC) through MRI analysis. PPMS is characterized by the worsening of neurologic function without distinct relapses (also called attacks or exacerbations). Approximately 15 percent of MS patients fall into the PPMS category. The study, A Randomized Placebo-controlled Trial Evaluating Laquinimod in PPMS, Gauging Gradations In MRI and Clinical Outcomes (ARPEGGIO) is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled, Phase II clinical trial. ARPEGGIO is intended to serve as a proof-of-concept study for potential treatment with laquinimod in PPMS. The trial will evaluate two doses of laquinimod (0.6 and 1.5mg/day) in PPMS compared to placebo. The primary endpoint of the study is brain atrophy as defined by PBVC from baseline to week 48. Secondary endpoints include time to confirmed disability progression, the number of new T2 lesions and change in the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) score. ARPEGGIO has an estimated completion date of H2 2017.
