NCT06861101

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

A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JT002 in Adult Patients With Seasonal Allergic Rhinitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 370 (actual)
• Sponsor: Shanghai JunTop Biosciences Co., LTD · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	JT002 Nasal spray	200 μg BID, 400 μg BID, 400 μg QD, 800 μg QD, 64 patients per cohort, total 256 patients for treatment 14 days
DRUG	Placebo	Total 64 patients for treatment 14 days

Timeline

• Start date: 2025-02-24
• Primary completion: 2025-05-06
• Completion: 2025-05-14
• First posted: 2025-03-06
• Last updated: 2025-06-11

Locations

44 sites across 1 country: China