drugset / Trial / NCT06861101

Phase II Study of JT002 in the Treatment of Seasonal Allergic Rhinitis in Adults

NCT06861101 ↗

Phase 2 Completed 370 enrolled Shanghai JunTop Biosciences Co., LTD
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study included three phases: the treatment introduction period (4-7 days before randomization), the treatment period (14 days after randomization) and the follow-up period (7 days after the last dose). Eligible participants in this study entered the 4-7 day treatment introduction period. After completing the treatment introduction period, patients who did not meet the random exclusion criteria of this study were randomly assigned to one of the 4 dose cohorts in a 1:1:1:1 ratio, with 80 patients planned to be enrolled in each cohort, and then randomly assigned to receive the investigational product or placebo in the cohort at a 4:1 ratio, for a total of 320 patients. Participants were stratified by prior Drug therapy for Rhinitis allergic. Ultimately, the proportion of patients receiving 200 μg BID, 400 μg BID, 400 μg QD, 800 μg QD and placebo was 1:1:1:1:1 (64 patients in each group).

Timeline

Start
2025-02-24
Primary completion
2025-05-06
Completion
2025-05-14

Drugs

EvaluationDrugModalityDoseRoute
Subject JT002 Unknown 200 ug Intranasal
Subject JT002 Unknown 400 ug Intranasal
Subject JT002 Unknown 800 ug Intranasal