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

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)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07351734

Acronym

COPD

Enrollment

120

Registered

2026-01-20

Start date

2025-11-06

Completion date

2026-09-30

Last updated

2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Brief 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. 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

Interventions

DRUGJKN2403 Tablets

JKN2403 Tablets once daily orally, for 24 weeks

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The annualized incidence rate of moderate to severe AECOPD	at 24 months
The duration from the first administration to the first occurrence of moderate to severe AECOPD	at 24 months

Secondary

Measure	Time frame
trough (pre-bronchodilator) FEV1	at 4, 8, 12 ,16, 20 and 24 weeks
quality of life（SGRQ score）	at 4, 8,12, 16, 20 and 24 weeks
quality of life (CAT score)	at 4, 8,12, 16, 20 and 24 months
The annualized incidence rate of CID	at 24 weeks
The duration from the first administration to the first occurrence of CID	at 24 weeks

Countries

China

Contacts

CONTACTWeijie Guan Professor

battery203@163.com020-81566265

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026