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

Official 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)

Overview

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

• Drug JKN2403 Tablets
  JKN2403 Tablets once daily orally, for 24 weeks
• Drug Placebo
  Placebo

Primary outcome measures

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

Secondary outcome measures (5)

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou

Identifiers

NCT: NCT07351734 · JKN2403-IIa · JKN2403-IIa

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗