Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 10:45 AM
Study NCT ID:
NCT07402551
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-11
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of RC1416 Injection in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, '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': 180}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-04', 'studyFirstSubmitDate': '2026-01-28', 'studyFirstSubmitQcDate': '2026-02-04', 'lastUpdatePostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'moderate or severe COPD exacerbations (AECOPD) and forced expiratory volume in 1 Second (FEV1)', 'timeFrame': 'During 52 weeks', 'description': 'Evaluate the annualized rate of AECOPD and the change in FEV1 from baseline'}], 'secondaryOutcomes': [{'measure': 'The safety and tolerability', 'timeFrame': 'During 52 weeks', 'description': 'Adverse events, laboratory tests, vital signs, 12-lead electrocardiogram (ECG), and physical examinations.'}, {'measure': 'pharmacokinetic', 'timeFrame': 'During 52 weeks', 'description': 'Css, DF, Tmax.'}, {'measure': 'immunogenicity', 'timeFrame': 'During 52 weeks', 'description': 'ADA positivity rate and titer, and NAb positivity rate.'}, {'measure': 'biomarkers predictive of the efficacy', 'timeFrame': 'During 52 weeks', 'description': 'FeNO, total IgE, eosinophil count, and TARC levels.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of RC1416 injection in patients with moderate to severe chronic obstructive pulmonary disease (COPD).', 'detailedDescription': 'Each participant will receive the study treatment once every two weeks for a total treatment duration of 52 weeks. The study aims to evaluate the annualized rate of moderate or severe COPD exacerbations (AECOPD) and the change in FEV1 from baseline over the 52-week treatment period. The changes in FeNO, total IgE, eosinophil count, and TARC levels from baseline will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 40 to 85 years (inclusive) at the time of signing the informed consent form, regardless of gender.\n* Body Mass Index (BMI) ≥ 16 kg/m².\n* Meets the diagnostic criteria for chronic obstructive pulmonary disease (COPD), and has medical records or relevant documentation indicating a history of COPD for ≥ 12 months at screening.\n* Post-bronchodilator ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) \\< 0.7, and post-bronchodilator FEV1 ≥ 30% and \\< 80% of the predicted value at screening.\n* A current smoker or former smoker with a smoking history of ≥ 10 pack-years, or a history of exposure to other risk factors.\n* A score of ≥ 2 on the modified Medical Research Council (mMRC) dyspnea scale at screening.\n* Medical records or relevant documentation showing ≥ 2 moderate COPD. exacerbations (AECOPD) or ≥ 1 severe AECOPD within the 12 months prior to screening.\n* Medical records or relevant documentation showing receipt of background triple therapy (ICS + LABA + LAMA) for ≥ 3 months prior to randomization.\n* A blood eosinophil count ≥ 150/mm³ (0.15×10⁹/L) at screening.\n\nExclusion Criteria:\n\n* A current diagnosis of asthma or a history of asthma.\n* Presence of other significant pulmonary diseases except COPD as judged by the Investigator.\n* History of malignancy .\n* A history of autoimmune diseases , or treatment with biologics or systemic immunosuppressants for inflammatory diseases within 8 weeks or 5 half-lives (whichever is longer) prior to signing the informed consent form.\n* Presence of recurrent, chronic, or other active infections at screening.\n* Currently receiving or planning to start long-term oxygen therapy or mechanical ventilation during the study period.\n* Diagnosis of α1-antitrypsin deficiency.\n* Active hepatitis B, active hepatitis C, positive human immunodeficiency virus (HIV) antibody, or positive Treponema pallidum antibody (TP-Ab).\n* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT07402551', 'briefTitle': 'Phase II Study of RC1416 Injection in COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nanjing RegeneCore Biotech Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of RC1416 Injection in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': 'RJK-RC1416-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RC1416 Injection', 'interventionNames': ['Drug: RC1416']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control', 'interventionNames': ['Drug: RC1416 Placebo']}], 'interventions': [{'name': 'RC1416', 'type': 'DRUG', 'description': 'There are two doses in this part. Each subjects will receive the drug by subcutaneous injection.', 'armGroupLabels': ['RC1416 Injection']}, {'name': 'RC1416 Placebo', 'type': 'DRUG', 'description': 'Each subjects will receive the placebo by subcutaneous injection.', 'armGroupLabels': ['Placebo Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230031', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'contacts': [{'name': 'Haohui Fang', 'role': 'CONTACT'}], 'facility': 'Anhui Provincial Chest Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '234000', 'city': 'Suzhou', 'state': 'Anhui', 'country': 'China', 'contacts': [{'name': 'Hui Jiang', 'role': 'CONTACT'}], 'facility': 'Wan Bei General Hospital of Wanbei Coal power Group', 'geoPoint': {'lat': 33.63611, 'lon': 116.97889}}, {'zip': '402760', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'contacts': [{'name': 'Rui Han', 'role': 'CONTACT'}], 'facility': 'The Affiliated Bishan Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '361004', 'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'contacts': [{'name': 'Yanping Du', 'role': 'CONTACT'}], 'facility': 'Zhongshan Hospital Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Nanshan Zhong', 'role': 'CONTACT'}], 'facility': 'The first affiliated hospital of guangzhou medical university', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Shenming Liu', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Jinan University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Yuming Zhou', 'role': 'CONTACT'}], 'facility': 'The first affiliated hospital of guangzhou medical university', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '516002', 'city': 'Huizhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Feng Wu', 'role': 'CONTACT'}], 'facility': "Huizhou Third People's Hospital", 'geoPoint': {'lat': 23.11147, 'lon': 114.41523}}, {'zip': '529000', 'city': 'Jiangmen', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Yanming Huang', 'role': 'CONTACT'}], 'facility': 'Jiangmen Central Hospital', 'geoPoint': {'lat': 22.58333, 'lon': 113.08333}}, {'zip': '511518', 'city': 'Qingyuan', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Dongbo Tian', 'role': 'CONTACT'}], 'facility': "Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital)", 'geoPoint': {'lat': 23.7, 'lon': 113.03333}}, {'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'contacts': [{'name': 'Zhiyi He', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '537000', 'city': 'Yulin', 'state': 'Guangxi', 'country': 'China', 'contacts': [{'name': 'Linling Zhu', 'role': 'CONTACT'}], 'facility': "The First People's Hospital of Yulin", 'geoPoint': {'lat': 22.6305, 'lon': 110.14686}}, {'zip': '563000', 'city': 'Zunyi', 'state': 'Guizhou', 'country': 'China', 'contacts': [{'name': 'Yuanbo Lan', 'role': 'CONTACT'}], 'facility': 'Affiliated Hospital of Zunyi Medical University', 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}, {'zip': '455000', 'city': 'Anyang', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Mingyong Jia', 'role': 'CONTACT'}], 'facility': "Anyang People's Hospital", 'geoPoint': {'lat': 36.096, 'lon': 114.38278}}, {'zip': '454000', 'city': 'Jiaozuo', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Xinqu Xu', 'role': 'CONTACT'}], 'facility': "Jiaozuo Second People's Hospital", 'geoPoint': {'lat': 35.23925, 'lon': 113.23914}}, {'zip': '473000', 'city': 'Nanyang', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Qun Ma', 'role': 'CONTACT'}], 'facility': "Nanyang First People's Hospital", 'geoPoint': {'lat': 33.00524, 'lon': 112.54659}}, {'zip': '473000', 'city': 'Nanyang', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Fengling, Ju', 'role': 'CONTACT'}], 'facility': "Nanyang Second People's Hospital", 'geoPoint': {'lat': 33.00524, 'lon': 112.54659}}, {'zip': '472000', 'city': 'Sanmenxia', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Kuan Liu', 'role': 'CONTACT'}], 'facility': 'Sanmenxia Central Hospital', 'geoPoint': {'lat': 34.78081, 'lon': 111.19287}}, {'zip': '453000', 'city': 'Xinxiang', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Xiangjie Zhang', 'role': 'CONTACT'}], 'facility': "Xinxiang First People's Hospital", 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}, {'zip': '443000', 'city': 'Yichang', 'state': 'Hubei', 'country': 'China', 'contacts': [{'name': 'Xiaoqi Xiong', 'role': 'CONTACT'}], 'facility': "Yichang Central People's Hospital", 'geoPoint': {'lat': 30.71444, 'lon': 111.28472}}, {'zip': '417000', 'city': 'Loudi', 'state': 'Hunan', 'country': 'China', 'contacts': [{'name': 'Lixuan Chen', 'role': 'CONTACT'}], 'facility': 'Loudi Central Hospital', 'geoPoint': {'lat': 27.73444, 'lon': 111.99444}}, {'zip': '010030', 'city': 'Hohhot', 'state': 'Inner Mongolia', 'country': 'China', 'contacts': [{'name': 'Lihong Wang', 'role': 'CONTACT'}], 'facility': 'The Affiliated Hospital of Inner Mongolia Medical University', 'geoPoint': {'lat': 40.81056, 'lon': 111.65222}}, {'zip': '222061', 'city': 'Lianyungang', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Jiashu Li', 'role': 'CONTACT'}], 'facility': "The First People's Hospital of Lianyungang City", 'geoPoint': {'lat': 34.59845, 'lon': 119.21556}}, {'zip': '210006', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Surong Fang', 'role': 'CONTACT'}], 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '221009', 'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Yanmin Wu', 'role': 'CONTACT'}], 'facility': 'Xuzhou Central Hospital', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'zip': '225012', 'city': 'Yangzhou', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Feng Wu', 'role': 'CONTACT'}], 'facility': 'Yangzhou University Affiliated Hospital', 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}, {'zip': '332000', 'city': 'Jiujiang', 'state': 'Jiangxi', 'country': 'China', 'contacts': [{'name': 'Jun Li', 'role': 'CONTACT'}], 'facility': "Jiu Jiang NO.1 People's Hospital", 'geoPoint': {'lat': 29.70475, 'lon': 116.00206}}, {'city': 'Pingxiang', 'state': 'Jiangxi', 'country': 'China', 'contacts': [{'name': 'Haibo Shen', 'role': 'CONTACT'}], 'facility': "People's Hospital of Pingxiang City", 'geoPoint': {'lat': 27.61672, 'lon': 113.85353}}, {'zip': '130041', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'contacts': [{'name': 'Ke Wang', 'role': 'CONTACT'}], 'facility': 'The Second Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '110004', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'contacts': [{'name': 'Li Zhao', 'role': 'CONTACT'}], 'facility': 'Shengjing Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '252000', 'city': 'Liaocheng', 'state': 'Shandong', 'country': 'China', 'contacts': [{'name': 'Yan Wang', 'role': 'CONTACT'}], 'facility': "LiaoCheng People's Hospital", 'geoPoint': {'lat': 36.45064, 'lon': 116.00247}}, {'zip': '266000', 'city': 'Qingdao', 'state': 'Shandong', 'country': 'China', 'contacts': [{'name': 'Yi Su', 'role': 'CONTACT'}], 'facility': 'Qingdao Municipal Hospital', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'zip': '261041', 'city': 'Weifang', 'state': 'Shandong', 'country': 'China', 'contacts': [{'name': 'Guoru Yang', 'role': 'CONTACT'}], 'facility': "The Second People's Hospital of Weifang", 'geoPoint': {'lat': 36.71, 'lon': 119.10194}}, {'zip': '255499', 'city': 'Zibo', 'state': 'Shandong', 'country': 'China', 'contacts': [{'name': 'Lijun Suo', 'role': 'CONTACT'}], 'facility': 'Zibo Municipal Hospital', 'geoPoint': {'lat': 36.79056, 'lon': 118.06333}}, {'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Haiwen Lu', 'role': 'CONTACT'}], 'facility': 'Shanghai Pulmonary Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610031', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'contacts': [{'name': 'Guoping Li', 'role': 'CONTACT'}], 'facility': "The Third People's Hospital of Chengdu City", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '611130', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'contacts': [{'name': 'Xiao Liu', 'role': 'CONTACT'}], 'facility': "Chengdu Fifth People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '621099', 'city': 'Mianyang', 'state': 'Sichuan', 'country': 'China', 'contacts': [{'name': 'Weiguo Xu', 'role': 'CONTACT'}], 'facility': 'Mianyang central hospital', 'geoPoint': {'lat': 31.46784, 'lon': 104.68168}}, {'zip': '629000', 'city': 'Suining', 'state': 'Sichuan', 'country': 'China', 'contacts': [{'name': 'Rong Qiu', 'role': 'CONTACT'}], 'facility': 'Suining Central Hospital', 'geoPoint': {'lat': 30.50802, 'lon': 105.57332}}, {'zip': '643000', 'city': 'Zigong', 'state': 'Sichuan', 'country': 'China', 'contacts': [{'name': 'Zhiping Deng', 'role': 'CONTACT'}], 'facility': "Zigong First People's Hospital Zigong Academy of Medicalsciences", 'geoPoint': {'lat': 29.34162, 'lon': 104.77689}}, {'zip': '325035', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Liqin Wu', 'role': 'CONTACT'}], 'facility': "The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU", 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'centralContacts': [{'name': 'Yumin Zhou, MD', 'role': 'CONTACT', 'email': 'zhouyumin410@126.com', 'phone': '+86-13826190798'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing RegeneCore Biotech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}