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The trial will measure total nasal symptom score (TNSS), total ocular symptom score (TOSS) and other secondary endpoints.
The criteria for a successful priming session was a patient-assessed instantaneous total nasal symptom score of at least 6 (of a possible 12) and a nasal congestion or rhinorrhea score of at least 2 (of a possible 3) 90 minutes after allergen exposure during at least two consecutive priming sessions.
Patient-reported diaries were used to record change from baseline in morning reflective and instantaneous total nasal symptom score (AM rTNSS, AM iTNSS) and reflective and instantaneous total ocular symptom score (AM rTOSS, AM iTOSS), averaged over the two week treatment period.
The results demonstrated that VTX-1463 significantly improved allergy symptoms based on Total Nasal Symptom Scores (TNSS) compared to placebo (p=0.
Total nasal symptom scores (TNSS) were obtained every 4 weeks during the 52-week study.
Safety and tolerability assessments were conducted at regular intervals during the one-year study and efficacy was assessed as a secondary endpoint by the 12-hour reflective total nasal symptom score (rTNSS) scored once daily in the evening each day of the study.
15% experienced a significant reduction in total nasal symptom scores (TNSS) over the entire study period compared to placebo.
The study's primary efficacy measure was the change from baseline in the average patient-assessed total nasal symptom score (TNSS), defined as the sum of the scores for four nasal symptoms: runny nose, itchy nose, sneezing, and nasal congestion.