Date: 2015-09-21
Type of information: Halting of the trial
phase: 3
Announcement: halting of the trial
Company: AB Science (France)
Product: masitinib
Action mechanism:
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial details:
Latest
news: * On September 21, 2015, AB Science announced the decision to stop the phase 3 study of masitinib in rheumatoid arthritis in order to streamline its studies portfolio. This decision has been made following a futility test, conducted by the external Data and Safety Monitoring Board (DSMB), showing that the probability of success on the primary endpoint was below 50% for this study, including the resampling option.
The futility test is based on the study’s primary endpoint analysis without resampling and with a conditional power (predictive probability of success) of 20%. For this analysis it is considered that all the patients to be included in the study will follow the trend observed for patients already included at the time of the futility analysis. If the futility test is successful, the probability of success on the primary endpoint of the study may exceed 20%, without the resampling option. However, the study protocol includes also a resampling option (the possibility to increase the number of patients enrolled up to a factor two), which can be implemented if an efficacy trend is observed during the interim analysis that needs to be statistically demonstrated by increasing the number of patients in the study. Given the possibility of this option, the probability of success on the primary endpoint of the study
can be estimated at 50%, by modifying the study sampling size if the futility test is successful. Alternatively, if the futility test fails, the probability of success on the primary endpoint of the study is below 50% with the resampling option.
The Company policy is to focus on indications with a predictive probability of success greater than 50% and a high medical need.
The number of phase 3 studies initiated, which exceeds ten, makes possible this strategy to focus investments in the most promising indications. In addition, this strategy avoids incurring all the expenditures for a study with a probability of success deemed insufficient. As a reminder, mastocytosis, severe asthma, amyotrophic lateral sclerosis, progressive multiple sclerosis
and Alzheimer\'s disease meet this dual condition since these diseases all represent unmet medical needs and since the masitinib phase 3 studies in these indications passed the futility test successfully.
Alain Moussy, CEO and co-founder of AB Science stated: “Rheumatoid arthritis is the indication developed with masitinib for which the medical need is the lowest, given the large number of available therapeutic options. The futility test shows a probability of success below 50% with the resampling option. It does not mean that the study cannot be a success, but the probability of success is deemed insufficient according to our internal policy to justify continuation of this investment. That is why we made this decision to stop development in this indication and to focus on indications that have passed the futility test successfully”.
The clinical study in rheumatoid arthritis was designed to evaluate the efficacy and safety of masitinib in patients with active rheumatoid arthritis after failure of at least one standard treatment line including at least one biological agent. The primary efficacy measure in this study was the patient rate having an ARC50, which measures a 50% improvement of the disease symptoms.
