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Recruiting

NCT Number: NCT07351734

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

Recruiting

Interested in participating?

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Weijie Guan Professor

CONTACT

[email protected]

02081566265

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JKN2403 Tablets

Drug

JKN2403 Tablets once daily orally, for 24 weeks

Placebo

Drug

Placebo

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

  5. The duration from the first administration to the first occurrence of CID

    Time frame: at 24 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Weijie Guan Professor

CONTACT

[email protected]

020-81566265

Sponsors and collaborators

Lead sponsor

Joincare Pharmaceutical Group Industry Co., Ltd

Industry

Registry information

Official study title

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)

Acronym: COPD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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