ASIT Biotech: The 82-Centre Gp-ASIT+ Phase III Study Launches
Edison | Nov 20, 2018 08:32AM ET
In a well-received announcement, ASIT (BR:ASIT) has launched the confirmatory Phase III study on gp-ASIT+ for grass pollen allergy with study centres in six European countries. The results of the study are expected in December 2019. ASIT has learned from the previous Phase III study by making a number of improvements to the protocol to enhance the chances of success. In addition, ASIT has made announcements on its other products illustrating its pipeline in allergy extends beyond gp-ASIT+.
(Protocol) change is good
The primary endpoint of the Phase III study of gp-ASIT+ for grass pollen allergy remains the same as in the first Phase III study that reported in 2017: a 20% reduction in the combined clinical symptom and medication score in the treatment arm compared to the placebo patients. However, a number of potentially confounding variables have been addressed in the planned conduct of this second confirmatory study. The choice of ICON as the single clinical research organisation for the study brings ICON’s deep experience in running allergy clinical trials. Of the eight other improvements in the Phase III protocol, the restriction in the maximum number of patients that can be recruited at any one of the centres and the increase in the number of patients to 624 (from 554 in the first Phase III study) are the most important. An earlier launch date in the pollen season, the recruitment of more severe patients than in the first Phase III study and the selection of centres with regular historical pollen levels are also important variables to re-define.
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ASIT Biotech: The 82-Centre Gp-ASIT+ Phase III Study Launches
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