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

NCT06861101 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2025-06-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shanghai JunTop Biosciences Co., LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06861101 on ClinicalTrials.gov