COPD (Chronic Obstructive Pulmonary Disease)Phase 2NCT07440524
A Phase 2 Trial of JKN24011 in COPD
A Phase 2 study testing JKN24011 in people with COPD (Chronic Obstructive Pulmonary Disease), run by Joincare Pharmaceutical Group Industry Co., Ltd at 1 site in China.
Trial summary
A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of Subcutaneous JKN24011 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) 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?
- JKN24011
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 215 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 2 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 and/or biomass exposure).
- 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.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of Subcutaneous JKN24011 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of Subcutaneous JKN24011 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Read the detailed description
JKN24011 targets TSLP
- Being tested
- JKN24011, Placebo
- Keywords
- JKN2401, JKN24011, TSLP
- 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.
JKN24011Biological
JKN24011 subcutaneous injection,Q4W
PlaceboOther
Placebo subcutaneous injection,Q4W
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Injection, SC Receives: Other: Placebo |
| JKN24011 A | Experimental | JKN24011,SC,DOSE A Receives: Biological: JKN24011 |
| JKN24011 B | Experimental | JKN24011, SC, DOSE B Receives: Biological: JKN24011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualised rate of moderate or severe COPD exacerbations
Measured: Through the 52-week treatment period
Annualised rate of moderate or severe COPD exacerbations
Measured: Through the 28-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Aug 2024
- Primary completion2 Apr 2026
- Study completion2 Apr 2026
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
- 215 participants (actual)
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
- NCT07440524
- Sponsor's protocol ID
- JKN2401-Ⅱ
- Status last verified
- Oct 2026
- First submitted
- 23 Feb 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of Subcutaneous JKN24011 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT07440524
- Acronym / sponsor ID
- JKN2401-Ⅱ
- Keywords
- JKN2401, JKN24011, TSLP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Joincare Pharmaceutical Group Industry Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 27 Feb 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.
A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of Subcutaneous JKN24011 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Detailed description
JKN24011 targets TSLP
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo Injection, SC |
| JKN24011 A | Experimental | Biological: JKN24011JKN24011,SC,DOSE A |
| JKN24011 B | Experimental | Biological: JKN24011JKN24011, SC, DOSE B |
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 and/or biomass exposure).
- 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 |
|---|---|---|
| JKN24011JKN24011 subcutaneous injection,Q4W | Biological | JKN24011 A, JKN24011 B |
| PlaceboPlacebo subcutaneous injection,Q4W | Other | Placebo |
Primary outcome
Annualised rate of moderate or severe COPD exacerbations
Time frame: Through the 52-week treatment period
Annualised rate of moderate or severe COPD exacerbations
Time frame: Through the 28-week treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 JKN24011 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: finished, as of the sponsor's last update on 15 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualised rate of moderate or severe COPD exacerbations (time frame: Through the 52-week treatment period). 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 15 Oct 2026.