Date: 2015-07-23
Type of information: DSMB assessment
phase: 3
Announcement: DSMB assessment
Company: AB Science (France)
Product: masitinib
Action
mechanism: kinase inhibitor/tyrosine kinase inhibitor.
Disease: multiple sclerosis
Therapeutic area: Autoimmune diseases - Neurodegenerative diseases
Country: International study
Trial
details: This international, multicenter, randomized, double-blind, placebo-controlled, phase 3 study is to compare efficacy and safety of masitinib at 6 mg/kg/day to placebo in the treatment of patients with primary or relapse-free secondary progressive multiple sclerosis patients. The studystudy will enroll approximately 450 patients, across 60 centers around the world. The primary response evaluation will be the proportion of patient to achieve a relative variation of the Multiple Sclerosis Functional Composite (MSFC) of more than 100 % after 96 weeks of treatment. Secondary outcome measures will include Multiple Sclerosis Quality of Life 54 items (MSQOL-54) after 96 weeks of treatment.
Latest
news: * On July 23, 2015, AB Science announced the successful completion of a futility analysis related to the masitinib phase 3 trial for the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis. Based on these results, the Independent Data Safety Monitoring Committee (IDMC) has recommended the continuation of the study. The ongoing phase 3 trial is a double-blind, randomized, placebo-controlled study (AB07002) designed to assess the safety and efficacy of masitinib in patients with primary progressive or relapse-free secondary progressive multiple sclerosis. The treatment period is 96 weeks. The main measures to assess efficacy of masitinib in this disease are: - Change in MSFC (Multiple Sclerosis Functional Composite), which is a three-part assessment instrument to measure leg function/ambulation, arm/hand function, and cognitive function. * On October 6, 2014, AB Science announced that the external Data and Safety Monitoring Board (DSMB) has recommended the continuation of its phase 3 study of masitinib in primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis based upon review of the latest safety data. These results are reassuring because they confirm there are no observed safety concerns with masitinib over a 2-year treatment period. * On September 6, 2011, AB Science has recruited the first patient into a phase 3 study assessing its lead product masitinib in primary or relapse-free secondary progressive multiple sclerosis patients.
- Change in the MSQOL-54 (Multiple Sclerosis Quality of Life 54 items), which is a quality of life measure.
- Change in EDSS (Expanded Disability Status Scale), which is a scale used for quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time.
The study is intended to enroll 600 patients. This study was assessed as non-futile by the IDMC. The characteristics of the futility test were as follows:
- Performed after approximately one third of the planned study population had reached the 48 week treatment duration period
- Hypothesis that all the remaining patients to be enrolled in the study will follow the trend observed on the patient already enrolled at the time of futility analysis.
- P-value below 5%
- Conditional power (predictive probability of success) of 20%
More importantly, the IDMC highlighted that the study was not futile on the three main assessment criteria, MSFC, MSQOL-54, and EDSS.
The study previously successfully passed all safety data reviews by the IDMC, indicating that there is no major or unexpected safety concern with masitinib in this patient population.
The next step for this study is a second futility analysis once one third of patients have reached the 96 week time point. Then an interim analysis is expected once 50% of patients planned to be enrolled have reached the 96 week treatment duration period.
