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A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial of JKN2403 in COPD

ConditionCOPD (Chronic Obstructive Pulmonary Disease)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • JKN2403 Tablets

    Drug

    JKN2403 Tablets once daily orally, for 24 weeks

  • Placebo

    Drug

    Placebo

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: dose1 of JKN2403 Tablets, once daily orallyExperimental treatment 1 intervention
Group B: dose2 of JKN2403 Tablets once daily orallyExperimental treatment 1 intervention
Group C: dose3 of JKN2403 Tablets once dailyExperimental treatment 1 intervention
Group D: Placebo once dailyPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The annualized incidence rate of moderate to severe AECOPD

Time frame
at 24 months
2

The duration from the first administration to the first occurrence of moderate to severe AECOPD

Time frame
at 24 months

Secondary outcomes

1

trough (pre-bronchodilator) FEV1

Time frame
at 4, 8, 12 ,16, 20 and 24 weeks
2

quality of life（SGRQ score）

Time frame
at 4, 8,12, 16, 20 and 24 weeks
3

quality of life (CAT score)

Time frame
at 4, 8,12, 16, 20 and 24 months
4

The annualized incidence rate of CID

Time frame
at 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Joincare Pharmaceutical Group Industry Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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