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

Sponsor
Reistone Biopharma Company Limited
Study ID
NCT07349524
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • RSS0343 tablets — DRUG
    RSS0343 tablets
  • RSS0343 tablets Placebo — DRUG
    RSS0343 tablets Placebo

Study Details

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.

Key Dates

First listed
Jan 16, 2026
Start date
Mar 10, 2026
Status verified
Jan 2026
Primary completion
Mar 31, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RSS0343 tablets
  • Placebo Comparator: RSS0343 tablets Placebo

Primary Outcome Measure

Annualized rate of moderate or severe exacerbations of COPD during the 48-week treatment period [ Time Frame: during the 48-week treatment period ]

Central Contacts

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