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

NCT07349524 | Recruiting Phase 2

• 1 other identifier: RSS0343-202
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Annualized rate of moderate or severe exacerbations of COPD during the 48-week treatment period

  during the 48-week treatment period

Secondary Outcomes (10)

• The annualized rate of moderate or severe exacerbations of COPD at week 12, 24, and 36；

  at week 12, 24, and 36;

• The time to first moderate or severe exacerbations of COPD at week 24 and 48;

  at week 24 and 48;

• The proportion of patients experiencing moderate or severe exacerbations of COPD at week 24 and 48

  at week 24 and 48

• The change from baseline in pre- and post-bronchodilator forced expiratory volume in 1 second (FEV₁) at week 4, 8, 12, 24, 36, 48, and 52

  at week 4, 8, 12, 24, 36, 48, and 52

• The change from baseline in pre- and post-bronchodilator forced expiratory volume in FEV₁% predicted at week 4, 8, 12, 24, 36, 48, and 52

  at week 4, 8, 12, 24, 36, 48, and 52

Study Arms (2)

RSS0343 tablets

EXPERIMENTAL

Drug: RSS0343 tablets

RSS0343 tablets Placebo

PLACEBO COMPARATOR

Drug: RSS0343 tablets Placebo

Interventions

RSS0343 tablets DRUG

RSS0343 tablets

RSS0343 tablets

RSS0343 tablets Placebo DRUG

RSS0343 tablets Placebo

RSS0343 tablets Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign a written informed consent form.
• Aged 40 to 80 years, male or female.
• Body mass index (BMI) ≥18 kg/m².
• 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.
• Post-bronchodilator FEV₁/FVC \<0.7 at the screening period; and post-bronchodilator FEV₁/FVC \<0.7 with FEV₁% predicted ≥20% at baseline.
• Documented history of at least ≥1 moderate or severe acute exacerbation of COPD (AECOPD) within 12 months prior to screening.
• On stable doses of triple therapy or dual therapy for COPD maintenance treatment for ≥3 months prior to screening.
• COPD Assessment Test (CAT) score ≥10 at screening and randomization.
• Current or former smoking history of ≥10 pack-years at screening.
• 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.

You may not qualify if:

• 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.
• Subjects with medications known to potentially cause skin hyperkeratosis within 4 weeks prior to screening.
• 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.
• Subjects with strong CYP3A inducers or inhibitors within 14 days or 5 half-lives (whichever is longer) prior to randomization.
• Administration of live, attenuated live, or viral vector vaccines within 4 weeks prior to randomization.
• 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.
• Prior treatment with RSS0343 tablets or treatment with products targeting the same mechanism of action within 3 months prior to screening.
• Lung surgery or lung volume reduction surgery within 1 year prior to screening; or interventional procedures for chronic bronchitis within 1 year prior to screening.
• 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.
• Presence of a moderate or severe acute exacerbation of COPD (AECOPD) from 4 weeks prior to screening up to randomization.
• Coexisting other respiratory or respiratory-related diseases.
• Occurrence of pulmonary or other infections requiring systemic anti-infective therapy from 4 weeks prior to screening up to randomization.
• Presence of autoimmune diseases mediated by eosinophils at screening.
• Diagnosis of hypothyroidism, myxedema, chronic lymphedema, acromegaly, or livedo reticularis.
• Diagnosis of psoriasis or lichen planus; Reiter's disease/keratoderma blennorrhagicum, keratoderma hemorrhagicum, or reactive arthritis; systemic lupus erythematosus, atopic dermatitis, chronic hand dermatitis, chronic contact dermatitis, or chronic psoriasis; chloracne, extensive verruca vulgaris, or keratotic dermatitis.

Sponsors & Collaborators

• Reistone Biopharma Company Limited: lead

Study Sites (1)

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510140, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zhou Li

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-01

Locations

CN (1)