Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 11:43 PM
Study NCT ID:
NCT07054034
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-08
First Post:
2025-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of MG-ZG122 Humanized Monoclonal Antibody in Asthma Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of MG-ZG122 Humanized Monoclonal Antibody Injection in Adult Subjects with Moderate-to-Severe Asthma to Evaluate Efficacy and Safety'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-05-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2025-05-27', 'studyFirstSubmitQcDate': '2025-07-02', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annual incidence rate of asthma exacerbations', 'timeFrame': '48week', 'description': 'Annualized rate of severe asthma exacerbations over 48 weeks of treatment with MG-ZG122 compared to placebo.'}], 'secondaryOutcomes': [{'measure': 'Absolute change in FEV1 from baseline', 'timeFrame': '12week', 'description': 'Absolute change in pre-bronchodilator FEV1 from baseline at Week 12'}, {'measure': 'Absolute change in FEV1 from baseline', 'timeFrame': '24week', 'description': 'Absolute change in pre-bronchodilator FEV1 from baseline at Week 2424'}, {'measure': 'Hospitalization due to asthma exacerbation events', 'timeFrame': '48week', 'description': 'Annualized rate of hospitalizations or emergency department treatments due to severe asthma exacerbations during 48 weeks of treatment'}, {'measure': 'Proportion of subjects with asthma exacerbations', 'timeFrame': '48week', 'description': 'Proportion of subjects who experienced asthma exacerbations during 48 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bronchial Asthma'], 'conditions': ['Bronchial Asthma']}, 'descriptionModule': {'briefSummary': 'A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of MG-ZG122 Humanized Monoclonal Antibody Injection in Asthma Subjects, with Dosing Every 12 or 24 Weeks for 48 Weeks', 'detailedDescription': 'This study is a multicenter, randomized, double-blind, placebo-controlled Phase II study. Approximately 160 adult asthma subjects are scheduled to receive multiple subcutaneous injections (every 12 or 24 weeks for 48 weeks). The study is divided into a screening period (1 week), a run-in period (4 weeks), a treatment period (48 weeks), and a follow-up period (12 weeks).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be enrolled in this study:\n\nAge: 18 to 75 years old (inclusive), male or female.\n\nAsthma Diagnosis:\n\nDiagnosed with asthma for at least 1 year, and current disease status meets the diagnostic criteria of the 2024 GINA Guidelines (Global Initiative for Asthma).\n\nAdditionally:\n\nHas received moderate-to-high dose inhaled corticosteroids (ICS) for at least 2 consecutive months prior to screening.\n\nPre-bronchodilator FEV1 (forced expiratory volume in 1 second) at screening and baseline visits is ≤80% of predicted normal value.\n\nAsthma Control Questionnaire-5 (ACQ-5) score ≥1.5 at screening and baseline visits.\n\nHas experienced ≥1 severe asthma exacerbation within the 12 months prior to screening.\n\nExclusion Criteria:\n\n* 1， Known hypersensitivity to the investigational product or its excipients. 2，Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases potentially impairing lung function (e.g., idiopathic pulmonary fibrosis, pneumothorax, atelectasis, pulmonary fibrosis, bronchial dysplasia, etc.), as determined by the investigator., 3，Experienced a severe asthma exacerbation during the screening period or within 1 month prior to dosing., 4，Received systemic glucocorticoid therapy from 1 month prior to screening to prior to dosing (excluding topical, ophthalmic, or intranasal glucocorticoids).\n\n 5，Had pulmonary or other site infections requiring intravenous antibiotics, antifungal, or antiviral medications within 1 month prior to dosing.\n\n 6，Received intravenous immunoglobulin (IVIG) therapy or allergen-specific immunotherapy (SIT) within 3 months prior to dosing.\n\n 7，Used traditional Chinese herbal medicines with bronchodilatory or anti-asthmatic effects (excluding topical preparations) within 1 month prior to dosing.\n\n 8，Underwent major surgery within 8 weeks prior to screening or planned to undergo major surgery during the study period (including hospitalized surgery and day-case surgery).'}, 'identificationModule': {'nctId': 'NCT07054034', 'briefTitle': 'Study of MG-ZG122 Humanized Monoclonal Antibody in Asthma Subjects', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Shanghai Mabgeek Biotech.Co.Ltd'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of MG-ZG122 Humanized Monoclonal Antibody Injection in Adult Subjects With Moderate-to-Severe Asthma to Evaluate Efficacy and Safety', 'orgStudyIdInfo': {'id': 'MG-ZG122-AS-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MG-ZG122 Regimen 1', 'description': 'Group MG-ZG122 210 mg Q12W: Subcutaneous injection of MG-ZG122 210 mg + subcutaneous injection of 2.0 mL placebo (to maintain blinding), administered once every 12 weeks, with a total of 4 administrations.', 'interventionNames': ['Drug: MG-ZG122 Humanized Monoclonal Antibody Injection']}, {'type': 'EXPERIMENTAL', 'label': 'MG-ZG122 Regimen 2', 'description': 'MG-ZG122 210 mg administered via subcutaneous injection plus 2.0 mL placebo via subcutaneous injection (to maintain blinding), once every 24 weeks. To maintain blinding, 4.0 mL placebo injections will be administered at Weeks 12 and 36, for a total of 4 doses.', 'interventionNames': ['Drug: MG-ZG122 Humanized Monoclonal Antibody Injection']}, {'type': 'EXPERIMENTAL', 'label': 'MG-ZG122 Regimen 3', 'description': 'MG-ZG122 420 mg administered via subcutaneous injection, once every 24 weeks. To maintain blinding, 4.0 mL placebo injections will be administered at Weeks 12 and 36, for a total of 4 doses.', 'interventionNames': ['Drug: MG-ZG122 Humanized Monoclonal Antibody Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subcutaneous injection of 0 mg (4.0 mL placebo) once every 12 weeks, for a total of 4 administrations.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'MG-ZG122 Humanized Monoclonal Antibody Injection', 'type': 'DRUG', 'description': 'MG-ZG122 Humanized Monoclonal Antibody Injection', 'armGroupLabels': ['MG-ZG122 Regimen 1', 'MG-ZG122 Regimen 2', 'MG-ZG122 Regimen 3']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'MG-ZG122 Humanized Monoclonal Antibody Injection Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'China-Japan Friendship Hospital, Beijing, China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Mabgeek Biotech.Co.Ltd', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}