Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:44 PM
Study NCT ID:
NCT07351734
Status:
RECRUITING
Last Update Posted:
2026-01-20
First Post:
2026-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial of JKN2403 in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-10', 'studyFirstSubmitDate': '2026-01-10', 'studyFirstSubmitQcDate': '2026-01-10', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The annualized incidence rate of moderate to severe AECOPD', 'timeFrame': 'at 24 months'}, {'measure': 'The duration from the first administration to the first occurrence of moderate to severe AECOPD', 'timeFrame': 'at 24 months'}], 'secondaryOutcomes': [{'measure': 'trough (pre-bronchodilator) FEV1', 'timeFrame': 'at 4, 8, 12 ,16, 20 and 24 weeks'}, {'measure': 'quality of life（SGRQ score）', 'timeFrame': 'at 4, 8,12, 16, 20 and 24 weeks'}, {'measure': 'quality of life (CAT score)', 'timeFrame': 'at 4, 8,12, 16, 20 and 24 months'}, {'measure': 'The annualized incidence rate of CID', 'timeFrame': 'at 24 weeks'}, {'measure': 'The duration from the first administration to the first occurrence of CID', 'timeFrame': 'at 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD (Chronic Obstructive Pulmonary Disease)']}, 'descriptionModule': {'briefSummary': '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:\n\nDoes drug JKN2403 reduce the incidence of AECOPD or improve the quality of life or alleviate symptoms related to COPD?\n\nResearchers 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.\n\nParticipants will:\n\nTake 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent; able and willing to comply with study procedures.\n* Adults with documented COPD diagnosis and medical history consistent with guideline criteria.\n* Relevant exposure history consistent with COPD (e.g., smoking).\n* On stable, guideline-based maintenance COPD therapy prior to randomization, per investigator judgment.\n* Protocol-defined exacerbation history, symptom burden, and lung function at screening.\n\nExclusion Criteria:\n\n* Current or past asthma, or other clinically significant respiratory disease that may confound assessment.\n* Clinically significant uncontrolled comorbidities that increase risk or interfere with participation/outcomes.\n* Immunodeficiency/immune dysregulation, active autoimmune disease requiring systemic immunosuppression, or significant opportunistic infection history.\n* Active clinically significant infection or recent infection requiring systemic therapy; recent protocol-defined COPD exacerbation.\n* Current/recent malignancy (except low-risk, adequately treated cancers per protocol) or clinically significant abnormal screening labs.\n* 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.'}, 'identificationModule': {'nctId': 'NCT07351734', 'acronym': 'COPD', 'briefTitle': 'A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial of JKN2403 in COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Joincare Pharmaceutical Group Industry Co., Ltd'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'JKN2403-IIa'}, 'secondaryIdInfos': [{'id': 'JKN2403-IIa', 'type': 'OTHER_GRANT', 'domain': 'Joincare Pharmaceutical Group Industry Co., Ltd'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dose1 of JKN2403 Tablets, once daily orally', 'description': 'dose1 of JKN2403 Tablets once daily orally, for 24 weeks', 'interventionNames': ['Drug: JKN2403 Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'dose2 of JKN2403 Tablets once daily orally', 'description': 'dose2 of JKN2403 Tablets once daily orally, for 24 weeks', 'interventionNames': ['Drug: JKN2403 Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'dose3 of JKN2403 Tablets once daily', 'description': 'dose3 of JKN2403 Tablets once daily orally, for 24 weeks', 'interventionNames': ['Drug: JKN2403 Tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo once daily', 'description': 'Placebo once daily orally, for 24 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'JKN2403 Tablets', 'type': 'DRUG', 'description': 'JKN2403 Tablets once daily orally, for 24 weeks', 'armGroupLabels': ['dose1 of JKN2403 Tablets, once daily orally', 'dose2 of JKN2403 Tablets once daily orally', 'dose3 of JKN2403 Tablets once daily']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo once daily']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weijie Guan Professor', 'role': 'CONTACT', 'email': 'battery203@163.com', 'phone': '02081566265'}], 'facility': 'The First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Weijie Guan Professor', 'role': 'CONTACT', 'email': 'battery203@163.com', 'phone': '020-81566265'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joincare Pharmaceutical Group Industry Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}