Abstract
ABSTRACT
Background
The mannan‐conjugated birch pollen polymerised allergoid EP‐088_T502 has previously been shown to reduce allergic symptoms and anti‐allergic medication use during the birch pollen season. This confirmatory phase III trial aimed to evaluate the efficacy, safety, tolerability, and immunologic effects of EP‐088_T502 administered as eight subcutaneous injections over six pre‐seasonal treatment visits.
Methods
In this double‐blind, placebo‐controlled (DBPC) trial, 278 participants with birch pollen–induced allergic rhinoconjunctivitis (ARC) received either placebo or a cumulative dose of 28,000 mannan therapeutic units (mTU) of EP‐088_T502. The primary efficacy endpoint was the combined symptom and medication score (CSMS) during the peak birch pollen season. Safety, tolerability, health‐related quality of life (QoL), and immunologic parameters were also assessed.
Results
In the full analysis set (FAS), EP‐088_T502 significantly reduced the CSMS during the peak birch pollen season compared with placebo (mean absolute difference [MAD] −0.31; 95% confidence interval [CI], −0.56 to −0.05;
p
= 0.0169). In the per‐protocol (PP) and complete‐case sets, the corresponding MADs were −0.36 (
p
= 0.012) and −0.51 (
p
= 0.013), respectively. Health‐related QoL improved by 20% in the EP‐088_T502 group compared with placebo during the peak season (
p
p
p
Conclusions
EP‐088_T502 significantly improved symptom and medication scores in participants with birch pollen–induced ARC and induced a substantial Bet v 1‐specific IgG4 response. The 28,000 mTU regimen induced a substantial immunological response and showed an acceptable safety and tolerability profile.