Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT05671432
Status:
UNKNOWN
Last Update Posted:
2023-01-04
First Post:
2022-12-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Study of CM326 in Moderate-to-severe Atopic Dermatitis
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': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-31', 'studyFirstSubmitDate': '2022-12-26', 'studyFirstSubmitQcDate': '2022-12-31', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at visit 16', 'timeFrame': 'at week 16', 'description': 'The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD'}, {'measure': "Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and reduction from baseline of ≥2 points at Visit 16", 'timeFrame': 'at week 16', 'description': 'IGA is a 5-point scale ranging from 0 (clear) to 4 (very severe)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Moderate-to-severe Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, tolerance, pharmacokinetics, pharmacodynamics, and immunogenicity of CM326 in moderate-severe atopic dermatitis subjects.', 'detailedDescription': 'The study consists of 3 periods, a up-to-4-week Screening Period, a 52-week Treatment Period and a 8-week Safety Follow-up Period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* With confirmed Atopic Dermatitis (AD) at the screening.\n* Age ≥ 18 years and ≤ 75 years, male or female.\n* Have the ability to understand the nature of the study and voluntarily sign the informed consent.\n* Be able to communicate well with investigators and follow up protocol requirements.\n\nExclusion Criteria:\n\n* Not enough washing-out period for previous therapy.\n* Received allergen specific immunotherapy (desensitization) within 6 months prior to baseline.\n* Major surgery is planned during the study period.\n* Women who are pregnant or breastfeeding, or who plan to become pregnant during the study.'}, 'identificationModule': {'nctId': 'NCT05671432', 'briefTitle': 'The Study of CM326 in Moderate-to-severe Atopic Dermatitis', '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 CM326 Injection in the Treatment of Adult Patients With Moderate-to-severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'CM326-101102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Group A: CM326, subcutaneous (SC)', 'interventionNames': ['Biological: CM326']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Group A: CM326, subcutaneous (SC)', 'interventionNames': ['Biological: CM326']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group C', 'description': 'Group C: placebo, subcutaneous (SC)', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'CM326', 'type': 'BIOLOGICAL', 'description': 'CM326 injection', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianzhong Zhang', 'role': 'CONTACT'}], 'facility': "Peking University People's hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Qian Jia', 'role': 'CONTACT', 'email': 'qianjia@keymedbio.com', 'phone': '+862888610620'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keymed Biosciences Co.Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}