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

NCT07351734 | Recruiting Phase 2

• 1 other identifier: JKN2403-IIa
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (4)

dose1 of JKN2403 Tablets, once daily orally

EXPERIMENTAL

dose1 of JKN2403 Tablets once daily orally, for 24 weeks

Drug: JKN2403 Tablets

dose2 of JKN2403 Tablets once daily orally

EXPERIMENTAL

dose2 of JKN2403 Tablets once daily orally, for 24 weeks

Drug: JKN2403 Tablets

dose3 of JKN2403 Tablets once daily

EXPERIMENTAL

dose3 of JKN2403 Tablets once daily orally, for 24 weeks

Drug: JKN2403 Tablets

Placebo once daily

PLACEBO COMPARATOR

Placebo once daily orally, for 24 weeks

Drug: Placebo

Interventions

JKN2403 Tablets DRUG

JKN2403 Tablets once daily orally, for 24 weeks

dose1 of JKN2403 Tablets, once daily orally; dose2 of JKN2403 Tablets once daily orally; dose3 of JKN2403 Tablets once daily

Placebo DRUG

Placebo

Placebo once daily

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joincare Pharmaceutical Group Industry Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Weijie Guan Professor

CONTACT

020-81566265; battery203@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2026
• First Posted: January 20, 2026
• Study Start: November 6, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)