Actively Recruiting
A Study to Evaluate the Efficacy and Safety of RSS0343 Tablets in Patients With Chronic Obstructive Pulmonary Disease
Led by Reistone Biopharma Company Limited · Updated on 2026-04-17
237
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate the Efficacy and Safety of RSS0343 Tablets in Patients With Chronic Obstructive Pulmonary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign a written informed consent form.
- Aged 40 to 80 years, male or female.
- Body mass index (BMI) 618 kg/m�b2.
- Diagnosed with chronic obstructive pulmonary disease (COPD) with a history of at least 12 months.
- Post-bronchodilator FEV1/FVC ratio less than 0.7 at screening and baseline.
- Post-bronchodilator FEV1% predicted of 20% or more at baseline.
- History of at least one moderate or severe acute COPD exacerbation within 12 months before screening.
- Stable on dual or triple COPD maintenance therapy for at least 3 months prior to screening.
- COPD Assessment Test (CAT) score of 10 or higher at screening and randomization.
- Current or former smoker with a history of at least 10 pack-years.
- Male and female subjects of childbearing potential and their partners must use effective contraception and have no plans for conception or sperm/ova donation for 6 months (female) or 3 months (male) after the last dose.
- Female subjects of childbearing potential must have a negative pregnancy test during screening and before the first dose and must not be lactating.
You will not qualify if you...
- Use of systemic immunosuppressants, biologic agents, or Th2 cytokine inhibitors within 12 weeks before randomization or within 5 half-lives of the drug.
- Use of medications that may cause skin hyperkeratosis within 4 weeks before screening.
- Use of systemic corticosteroids, phosphodiesterase inhibitors, xanthine derivatives, leukotriene receptor antagonists, bacterial lysates, antitussive/expectorant medications, or blood products within 4 weeks before randomization.
- Use of strong CYP3A inducers or inhibitors within 14 days or 5 half-lives before randomization.
- Receipt of live, attenuated, or viral vector vaccines within 4 weeks before randomization.
- Participation in another clinical trial with investigational products within 3 months before screening or within 5 half-lives at screening.
- Prior treatment with RSS0343 tablets or similar mechanism drugs within 3 months before screening.
- Lung surgery or interventional procedures for chronic bronchitis within 1 year before screening.
- Need for supplemental oxygen therapy for 15 hours or more per day, mechanical ventilation, or treatment for significant sleep apnea requiring CPAP or NIPPV.
- Moderate or severe COPD exacerbation from 4 weeks before screening up to randomization.
- Other respiratory or respiratory-related diseases.
- Pulmonary or other infections requiring systemic anti-infective therapy from 4 weeks before screening up to randomization.
- Autoimmune diseases mediated by eosinophils.
- Diagnosis of hypothyroidism, myxedema, chronic lymphedema, acromegaly, or livedo reticularis.
- Diagnosis of psoriasis, lichen planus, Reiter's disease, keratoderma, systemic lupus erythematosus, atopic dermatitis, chronic hand or contact dermatitis, chloracne, extensive verruca vulgaris, or keratotic dermatitis.
- Other severe medical conditions.
- Abnormal laboratory tests, ECG, or other exams as defined by the protocol.
- Known hypersensitivity to the investigational product or its ingredients.
- Recent blood donation or blood loss exceeding specified amounts, blood transfusion within 8 weeks, or difficulty with venipuncture.
- Female subjects who are lactating, pregnant, or plan to become pregnant during the study.
- History of drug or substance abuse within 1 year before screening.
- Any other medical or social reason making participation unsuitable.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510140
Actively Recruiting
Research Team
Z
Zhou Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here