Ignite Creation Date:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2025-12-26 @ 10:18 PM
Study NCT ID:
NCT06930612
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-16
First Post:
2025-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （NEZHA-1）
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-09-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2025-04-09', 'studyFirstSubmitQcDate': '2025-04-09', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nasal Polyps Score (NPS)', 'timeFrame': 'at week 24', 'description': 'Change from baseline in the Nasal Polyps Score (NPS) at week 24. NPS score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Rhinosinusitis With Nasal Polyposis']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM512, and to observe the life quality of subjects, the Pharmacokinetics, Pharmacodynamics and immunogenicity of CM512 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).', 'detailedDescription': 'The study consists of a Screening Period (up to 4 weeks), Treatment Period (24 weeks for double-blind treatment period) and Safety Follow-up Period (12 weeks).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* with chronic rhinosinusitis with nasal polyposis (CRSwNP).\n* Nasal Polyp Score (NPS) of ≥5 with a minimum score of 2 in each nasal cavity.\n* Nasal Congestion Score of 2 or 3 at screening period, and at least 2 at baseline.\n* Contraception.\n\nExclusion Criteria:\n\n* Not enough washing out period for previous therapy, e.g., less than 10 weeks or 5 half-lives (whichever is longer) for Interleukin (IL)-4 receptor alpha subunit antagonists, less than 8 weeks or 5 half-lives for biologic therapy/systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).With malignant or benign tumor of nasal cavity.\n* Vaccination with live attenuated vaccine within 30 days before randomization or during the planned study period.'}, 'identificationModule': {'nctId': 'NCT06930612', 'briefTitle': 'A Study of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （NEZHA-1）', 'organization': {'class': 'INDUSTRY', 'fullName': 'Keymed Biosciences Co.Ltd'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis', 'orgStudyIdInfo': {'id': 'CM512-102101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CM512 Dose 1', 'interventionNames': ['Biological: CM512']}, {'type': 'EXPERIMENTAL', 'label': 'CM512 Dose 2', 'interventionNames': ['Biological: CM512']}, {'type': 'EXPERIMENTAL', 'label': 'CM512 Dose 3', 'interventionNames': ['Biological: CM512']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CM512', 'type': 'BIOLOGICAL', 'description': 'Administered subcutaneous injection', 'armGroupLabels': ['CM512 Dose 1', 'CM512 Dose 2', 'CM512 Dose 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered subcutaneous injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Tong-Ren hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Qian Jia', 'role': 'CONTACT', 'email': 'qianjia@keymedbio.com', 'phone': '028-88610620'}], 'overallOfficials': [{'name': 'Luo Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tong-Ren hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keymed Biosciences Co.Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}