A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial of JKN2403 in COPD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorJoincare Pharmaceutical Group Industry Co., Ltd
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- JKN2403 Tablets
- Placebo
Treatment groups
120 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov