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A Study to Evaluate the Efficacy and Safety of RSS0343 Tablets in Patients With Chronic Obstructive Pulmonary Disease | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

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

Evaluation of the Efficacy and Safety of RSS0343 Tablets in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Phase II, Randomized, Double-blind, Placebo-controlled Clinical Study.

NCT07349524•Reistone Biopharma Company Limited

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntarily sign a written informed consent form.
•2. Aged 40 to 80 years, male or female.
•3. Body mass index (BMI) ≥18 kg/m².
•4. Diagnosed with chronic obstructive pulmonary disease (COPD) as defined by the Chinese Guidelines for the Diagnosis and Management of COPD (2021 Revised Edition), with a documented COPD history of ≥12 months prior to screening.
•5. Post-bronchodilator FEV₁/FVC \<0.7 at the screening period; and post-bronchodilator FEV₁/FVC \<0.7 with FEV₁% predicted ≥20% at baseline.
•6. Documented history of at least ≥1 moderate or severe acute exacerbation of COPD (AECOPD) within 12 months prior to screening.
•7. On stable doses of triple therapy or dual therapy for COPD maintenance treatment for ≥3 months prior to screening.
•8. COPD Assessment Test (CAT) score ≥10 at randomization.
•9. Current or former smoking history of ≥10 pack-years at screening.
•10. Male and female subjects of childbearing potential and their partners must have no plans for conception or sperm/ova donation for 6 months (female subjects) or 3 months (male subjects) after the last dose and must voluntarily use effective contraception. Female subjects of childbearing potential must have a negative pregnancy test during screening and prior to the first dose and must not be lactating.

Exclusion Criteria

•1. Subjects with systemic immunosuppressants, biologic agents, or Th2 cytokine inhibitors within 12 weeks prior to randomization or within 5 half-lives of the drug, whichever is longer.
•2. Subjects with medications known to potentially cause skin hyperkeratosis within 4 weeks prior to screening.
•3. Subjects with the followings within 4 weeks prior to randomization: systemic corticosteroids, phosphodiesterase inhibitors, xanthine derivatives, leukotriene receptor antagonists, bacterial lysates, antitussive/expectorant medications, infusion of blood products or immunoglobulins.
•4. Subjects with strong CYP3A inducers or inhibitors within 14 days or 5 half-lives (whichever is longer) prior to randomization.
•5. Administration of live, attenuated live, or viral vector vaccines within 4 weeks prior to randomization.
•6. Participation in another clinical trial involving an investigational product with active ingredients within 3 months prior to screening, or still within 5 half-lives of the investigational product at screening.
•7. Prior treatment with RSS0343 tablets or treatment with products targeting the same mechanism of action within 3 months prior to screening.
•8. History of lobectomy; or lung volume reduction surgery within 1 year prior to screening; or interventional procedures for chronic bronchitis within 1 year prior to screening.
•9. Requirement for supplemental oxygen therapy for ≥15 hours per day or mechanical ventilation; or clinically significant sleep apnea requiring the use of a continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
•10. Presence of a moderate or severe acute exacerbation of COPD (AECOPD) from 4 weeks prior to screening up to randomization.
+11 more criteria

Locations (1)

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Key Dates

Start Date

February 1, 2026

Primary Completion Date

March 1, 2028

Completion Date

April 1, 2028

Last Updated

January 16, 2026

Enrollment

237

ESTIMATED participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

RSS0343 tablets

DRUG

RSS0343 tablets Placebo

DRUG

Contacts

Zhou Li

CONTACT

+86 17721288193 zhou.li.zl69@hengrui.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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