drugset / Trial / NCT07349524

A Study to Evaluate the Efficacy and Safety of RSS0343 Tablets in Patients With Chronic Obstructive Pulmonary Disease

NCT07349524

Phase 2 Recruiting 300 enrolled Reistone Biopharma Company Limited
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy and safety of RSS0343 tablets in patients with COPD. The study includes 3 study periods: a 4-week screening period, a 48-week treatment period, and a 4-week follow-up period. The primary endpoint is the annualized rate of moderate or severe exacerbations of COPD during the 48-week treatment period.

Timeline

Start
2026-03-10
Primary completion
2028-03
Completion
2028-04

Drugs

EvaluationDrugModalityDoseRoute
Subject RSS0343 Unknown