Tests RSS0343 tablets against placebo in chronic obstructive pulmonary disease

Trial details

Who runs it

Reistone Biopharma Company Limited

Trial code

NCT07349524

Record updated

5 June 2026

Original description

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.Read full original descriptionShow less

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 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.

Inclusion: 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.

Exclusion: 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; Occurrence of pulmonary or other infections requiring systemic anti-infective therapy from 4 weeks prior to screening up to randomization; Suspected or known hypersensitivity to the investigational product or any of its excipients; 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; History of drug abuse or substance abuse within 1 year prior to screening; Coexisting other respiratory or respiratory-related diseases; Presence of autoimmune diseases mediated by eosinophils at screening; 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; Known other severe medical conditions; Laboratory tests, electrocardiogram (ECG), or other auxiliary examinations during the screening or baseline periods meeting the protocol-defined exclusion criteria; Diagnosis of hypothyroidism, myxedema, chronic lymphedema, acromegaly, or livedo reticularis; Female subjects who are lactating, have a positive pregnancy test result, or plan to become pregnant during the study period; Any other medical or social reason deemed by the investigator to make the subject unsuitable for participation in the trial.

ClinicalTrials.gov NCT07349524