Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT06947993
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Platform Study to Evaluate the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D004485', 'term': 'Eczema'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 224}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2025-04-25', 'studyFirstSubmitQcDate': '2025-04-25', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-11-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the Eczema Area and Severity Index (EASI) score at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'EASI will be used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema.'}], 'secondaryOutcomes': [{'measure': 'EASI-75 response at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'EASI will be used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema.\n\nEASI-75 response is defined as achieving ≥ 75% improvement (reduction) in EASI score compared to baseline.'}, {'measure': 'Investigator Global Assessment (IGA) response at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'The IGA rating scale will be used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. The IGA score ranges from 0 (clear) to 4 (severe).\n\nIGA response is defined as clear or almost clear score with at least a 2 point-reduction from baseline'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atopic dermatitis', 'Dermatitis', 'Eczema', 'Moderate to severe'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This trial is designed to evaluate multiple compounds in participants with moderate to severe atopic dermatitis (AD).', 'detailedDescription': 'This is a multicenter, randomized, double-blind, placebo-controlled Phase II platform study to investigate the efficacy and safety of several interventions in participants with moderate to severe AD.\n\nThe first intervention planned to be evaluated is GHZ339. Participants will be randomly assigned to one of the study arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria of the master protocol:\n\n* Able and willing to sign the informed consent (IC)\n* Patients with a diagnosis of AD and onset of disease for at least 1 year\n* Moderate to severe AD\n\nKey Exclusion Criteria of the master protocol:\n\n* Participants with a clinically significant medical condition or infectious disease (specified in sub-protocol)\n* Participants with clinically significant abnormal hematology, clinical chemistry, or urine test results or clinically significant abnormal ECG\n* Participant with any other active inflammatory skin disease\n* Participants with any chronic, uncontrolled medical condition, which would put the participant at increased risk during the study (e.g., uncontrolled: diabetes, hypertension)\n* Participants with any clinically unstable disease states that would likely require systemic corticosteroids (e.g., uncontrolled asthma)\n\nAdditional inclusion and exclusion criteria may apply depending on the intervention specific requirements'}, 'identificationModule': {'nctId': 'NCT06947993', 'briefTitle': 'Platform Study to Evaluate the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Platform Study to Assess the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'CADPT17A12201'}, 'secondaryIdInfos': [{'id': '2024-519081-49', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GHZ339 Dose A', 'description': 'Participants who will receive GHZ339 at dose A during Treatment Period 1 will receive GHZ339 at dose A during Treatment Period 2', 'interventionNames': ['Drug: GHZ339']}, {'type': 'EXPERIMENTAL', 'label': 'GHZ339 Dose B', 'description': 'Participants who will receive GHZ339 at dose B during Treatment Period 1 will receive GHZ339 at dose B during Treatment Period 2', 'interventionNames': ['Drug: GHZ339']}, {'type': 'EXPERIMENTAL', 'label': 'GHZ339 Dose C', 'description': 'Participants who will receive GHZ339 at dose C during Treatment Period 1 will receive GHZ339 at dose C or A during Treatment Period 2', 'interventionNames': ['Drug: GHZ339']}, {'type': 'EXPERIMENTAL', 'label': 'GHZ339 Dose D', 'description': 'Participants who will receive GHZ339 at dose D during Treatment Period 1 will receive GHZ339 at dose D or A during Treatment Period 2', 'interventionNames': ['Drug: GHZ339']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants who will receive placebo during Treatment Period 1 will receive GHZ339 at dose A during Treatment Period 2', 'interventionNames': ['Drug: GHZ339', 'Drug: Placebo']}], 'interventions': [{'name': 'GHZ339', 'type': 'DRUG', 'description': 'GHZ339 administered at dose A, B, C and D', 'armGroupLabels': ['GHZ339 Dose A', 'GHZ339 Dose B', 'GHZ339 Dose C', 'GHZ339 Dose D', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35244', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72916', 'city': 'Fort Smith', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United 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