RSS0343 tablets for people with COPD

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.

This trial will test whether RSS0343 tablets can reduce moderate or severe COPD flare-ups and are safe in adults with a history of COPD who are already on maintenance inhaled therapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 237 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Reistone Biopharma Company Limited (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07349524 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase II trial with a 4-week screening period, a 48-week treatment period, and a 4-week follow-up. Participants are assigned to receive either RSS0343 tablets or matching placebo while continuing their stable dual or triple maintenance therapy. The primary endpoint is the annualized rate of moderate or severe COPD exacerbations over the 48-week treatment period. Key enrollment criteria include age 40–80, post-bronchodilator FEV1/FVC <0.70, at least one documented exacerbation in the prior 12 months, CAT score ≥10, and a ≥10 pack-year smoking history.

Who should consider this trial

Good fit: Ideal candidates are adults 40–80 years old with spirometric airflow obstruction (post-bronchodilator FEV1/FVC <0.70), FEV1% predicted ≥20%, a history of ≥1 moderate or severe exacerbation in the past year, CAT score ≥10, a ≥10 pack-year smoking history, and on stable dual or triple COPD maintenance therapy.

Not a fit: Patients with very mild COPD, without prior exacerbations in the past year, those not on stable maintenance therapy, or those with FEV1% predicted below 20% are unlikely to match the enrolled population and may not benefit from participation.

Why it matters

Potential benefit: If successful, RSS0343 could lower the number of moderate or severe COPD exacerbations and potentially reduce related symptoms and hospital visits.

How similar studies have performed: Other randomized, placebo-controlled Phase II trials of new COPD therapies have shown mixed results—some have reduced exacerbations while others have not—so this compound appears novel and its efficacy is not yet established.

Eligibility criteria

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 screening and 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. 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.
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. Coexisting other respiratory or respiratory-related diseases.
12. Occurrence of pulmonary or other infections requiring systemic anti-infective therapy from 4 weeks prior to screening up to randomization.
13. Presence of autoimmune diseases mediated by eosinophils at screening.
14. Diagnosis of hypothyroidism, myxedema, chronic lymphedema, acromegaly, or livedo reticularis.
15. 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.
16. Known other severe medical conditions.
17. Laboratory tests, electrocardiogram (ECG), or other auxiliary examinations during the screening or baseline periods meeting the protocol-defined exclusion criteria.
18. Suspected or known hypersensitivity to the investigational product or any of its excipients.
19. Blood donation or blood loss ≥200 mL within 1 month prior to randomization, or ≥400 mL within 3 months prior to the first dose; or receipt of a blood transfusion within 8 weeks prior to the first dose; or difficulty with venipuncture, or physical condition unsuitable for intensive blood sampling.
20. Female subjects who are lactating, have a positive pregnancy test result, or plan to become pregnant during the study period.
21. History of drug abuse or substance abuse within 1 year prior to screening.
22. Any other medical or social reason deemed by the investigator to make the subject unsuitable for participation in the trial.

Where this trial is running

Guangzhou, Guangdong

• First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Zhou Li

Conditions Chronic Obstructive Pulmonary Disease