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

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 Overview

• Status: Recruiting
• Conditions: COPD (Chronic Obstructive Pulmonary Disease)
• Intervention / Treatment: Drug: Placebo; Drug: JKN2403 Tablets

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Weijie Guan Professor; Phone Number: 020-81566265; Email: battery203@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
      • Contact: Weijie Guan Professor; Phone Number: 02081566265; Email: battery203@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dose1 of JKN2403 Tablets, once daily orally; dose1 of JKN2403 Tablets once daily orally, for 24 weeks	Drug: JKN2403 Tablets; JKN2403 Tablets once daily orally, for 24 weeks
Experimental: dose2 of JKN2403 Tablets once daily orally; dose2 of JKN2403 Tablets once daily orally, for 24 weeks	Drug: JKN2403 Tablets; JKN2403 Tablets once daily orally, for 24 weeks
Experimental: dose3 of JKN2403 Tablets once daily; dose3 of JKN2403 Tablets once daily orally, for 24 weeks	Drug: JKN2403 Tablets; JKN2403 Tablets once daily orally, for 24 weeks
Placebo Comparator: Placebo once daily; Placebo once daily orally, for 24 weeks	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Joincare Pharmaceutical Group Industry Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: January 10, 2026
• First Submitted That Met QC Criteria: January 10, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 10, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: JKN2403-IIa (Other Grant/Funding Number: Joincare Pharmaceutical Group Industry Co., Ltd)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No