COPD (Chronic Obstructive Pulmonary Disease)Phase 2COPDNCT07351734
A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial of JKN2403 in COPD
A Phase 2 study testing JKN2403 Tablets in people with COPD (Chronic Obstructive Pulmonary Disease), run by Joincare Pharmaceutical Group Industry Co., Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- JKN2403 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2025to 30 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Weijie Guan Professor, 02081566265, battery203@163.com
About this study
Official title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetic Characteristics of JKN2403 Tablets in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
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?
Read more
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
- Being tested
- JKN2403 Tablets, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JKN2403 TabletsDrug
JKN2403 Tablets once daily orally, for 24 weeks
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| dose1 of JKN2403 Tablets, once daily orally | Experimental | dose1 of JKN2403 Tablets once daily orally, for 24 weeks Receives: Drug: JKN2403 Tablets |
| dose2 of JKN2403 Tablets once daily orally | Experimental | dose2 of JKN2403 Tablets once daily orally, for 24 weeks Receives: Drug: JKN2403 Tablets |
| dose3 of JKN2403 Tablets once daily | Experimental | dose3 of JKN2403 Tablets once daily orally, for 24 weeks Receives: Drug: JKN2403 Tablets |
| Placebo once daily | Placebo comparator | Placebo once daily orally, for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The annualized incidence rate of moderate to severe AECOPD
Measured: at 24 months
The duration from the first administration to the first occurrence of moderate to severe AECOPD
Measured: at 24 months
Secondary outcomes (5)
trough (pre-bronchodilator) FEV1
Measured: at 4, 8, 12 ,16, 20 and 24 weeks
quality of life（SGRQ score）
Measured: at 4, 8,12, 16, 20 and 24 weeks
quality of life (CAT score)
Measured: at 4, 8,12, 16, 20 and 24 months
The annualized incidence rate of CID
Measured: at 24 weeks
The duration from the first administration to the first occurrence of CID
Measured: at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start6 Nov 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joincare Pharmaceutical Group Industry Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351734
- Sponsor's protocol ID
- JKN2403-IIa
- Other IDs
- JKN2403-IIa
- Acronym
- COPD
- Status last verified
- Jan 2026
- First submitted
- 10 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetic Characteristics of JKN2403 Tablets in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT07351734
- Acronym / sponsor ID
- COPD / JKN2403-IIa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Joincare Pharmaceutical Group Industry Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| dose1 of JKN2403 Tablets, once daily orally | Experimental | Drug: JKN2403 Tabletsdose1 of JKN2403 Tablets once daily orally, for 24 weeks |
| dose2 of JKN2403 Tablets once daily orally | Experimental | Drug: JKN2403 Tabletsdose2 of JKN2403 Tablets once daily orally, for 24 weeks |
| dose3 of JKN2403 Tablets once daily | Experimental | Drug: JKN2403 Tabletsdose3 of JKN2403 Tablets once daily orally, for 24 weeks |
| Placebo once daily | Placebo comparator | Drug: PlaceboPlacebo once daily orally, for 24 weeks |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JKN2403 TabletsJKN2403 Tablets once daily orally, for 24 weeks | Drug | dose1 of JKN2403 Tablets, once daily orally, dose2 of JKN2403 Tablets once daily orally, dose3 of JKN2403 Tablets once daily |
| PlaceboPlacebo | Drug | Placebo once daily |
Primary outcome
The annualized incidence rate of moderate to severe AECOPD
Time frame: at 24 months
The duration from the first administration to the first occurrence of moderate to severe AECOPD
Time frame: at 24 months
5 secondary outcomes
trough (pre-bronchodilator) FEV1
Time frame: at 4, 8, 12 ,16, 20 and 24 weeks
quality of life（SGRQ score）
Time frame: at 4, 8,12, 16, 20 and 24 weeks
quality of life (CAT score)
Time frame: at 4, 8,12, 16, 20 and 24 months
The annualized incidence rate of CID
Time frame: at 24 weeks
The duration from the first administration to the first occurrence of CID
Time frame: at 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JKN2403 Tablets in people with COPD (Chronic Obstructive Pulmonary Disease), run by Joincare Pharmaceutical Group Industry Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weijie Guan Professor (020-81566265, battery203@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The annualized incidence rate of moderate to severe AECOPD (time frame: at 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026; AzTrials last refreshed its copy on 31 Oct 2026.