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โ† Trials
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A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial of JKN2403 in COPD

RecruitingPhase 2Ages 40 Years - 80 YearsAllJoincare Pharmaceutical Group Industry Co., Ltd
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if drug JKN2403 works to treat moderate-to-severe COPD in adults. It will also learn about the safety and pharmacokinetic characteristics of drug JKN2403. The main questions it aims to answer are: Does drug JKN2403 reduce the incidence of AECOPD or improve the quality of life or alleviate symptoms related to COPD? Researchers will compare drug JKN2403 to a placebo (a look-alike substance that contains no drug) to see if drug JKN2403 works to treat moderate-to-severe COPD. Participants will: Take drug JKN2403 or a placebo every day for 24 weeks Visit the clinic once every four weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Written informed consent; able and willing to comply with study procedures. * Adults with documented COPD diagnosis and medical history consistent with guideline criteria. * Relevant exposure history consistent with COPD (e.g., smoking). * On stable, guideline-based maintenance COPD therapy prior to randomization, per investigator judgment. * Protocol-defined exacerbation history, symptom burden, and lung function at screening. Exclusion Criteria: * Current or past asthma, or other clinically significant respiratory disease that may confound assessment. * Clinically significant uncontrolled comorbidities that increase risk or interfere with participation/outcomes. * Immunodeficiency/immune dysregulation, active autoimmune disease requiring systemic immunosuppression, or significant opportunistic infection history. * Active clinically significant infection or recent infection requiring systemic therapy; recent protocol-defined COPD exacerbation. * Current/recent malignancy (except low-risk, adequately treated cancers per protocol) or clinically significant abnormal screening labs. * Prohibited recent vaccines or therapies, prior relevant biologic/targeted therapy exposure, severe hypersensitivity to biologics/IMP, - pregnancy/breastfeeding, or inability to comply (including substance abuse), per investigator judgment.
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What it tests

  • JKN2403 Tablets
  • Placebo
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Where

1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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