Tag: long-term efficacy
– Field-based trial with 196 patients shows significant reductions in seasonal allergy symptoms
– Efficacy of AllerT in both dose groups maintained during the second birch pollen season
A total of 196 patients were enrolled in the Phase IIb follow-up, double-blind, placebo-controlled, field-based clinical trial. The trial objective was to evaluate the long-term efficacy of AllerT in patients who had participated last year in the field-based Phase IIb trial with AllerT. Patients evaluated this year either received a placebo, AllerT 50 µg or AllerT 100 µg 18 months before the second birch pollen season. No further investigational treatment was given after the initial randomization.
Subjects who had received AllerT showed persistent, statistically significant (p<0.05) and clinically meaningful (>20% difference from placebo) reductions in the primary (combined symptom and medication score) and main secondary endpoints (quality of life score and nighttime nasal symptoms). The results were remarkably consistent across all clinical endpoints and did not show meaningful differences between Year 1 and Year 2 clinical responses. In addition, the clinical effects of both doses were very similar.
Full results of the trial will be presented at an upcoming scientific conference.
In 2013, Anergis had already shown that patients from the AllerT Phase IIa trial had a long-lasting elevation in allergen-specific antibodies (IgG4) until at least the fourth post-treatment season.