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

Joincare Pharmaceutical Group Industry Co., Ltd

Status and phase: Enrolling; Phase 2

Conditions: COPD (Chronic Obstructive Pulmonary Disease)

Treatments: Drug: Placebo; Drug: JKN2403 Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT07351734

JKN2403-IIa (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups, including a placebo group

dose1 of JKN2403 Tablets, once daily orally

Experimental group

Description:

dose1 of JKN2403 Tablets once daily orally, for 24 weeks

Treatment:

Drug: JKN2403 Tablets

dose2 of JKN2403 Tablets once daily orally

Experimental group

Description:

dose2 of JKN2403 Tablets once daily orally, for 24 weeks

Treatment:

Drug: JKN2403 Tablets

dose3 of JKN2403 Tablets once daily

Experimental group

Description:

dose3 of JKN2403 Tablets once daily orally, for 24 weeks

Treatment:

Drug: JKN2403 Tablets

Placebo once daily

Placebo Comparator group

Description:

Placebo once daily orally, for 24 weeks

Treatment:

Drug: Placebo