Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT06723405
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2024-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy Study of EVO301 in 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': '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': 'D003872', 'term': 'Dermatitis'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2024-12-04', 'studyFirstSubmitQcDate': '2024-12-04', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eczema Area and Severity Index (EASI)', 'timeFrame': '12 weeks', 'description': 'EASI assesses the extent and severity of atopic dermatitis. EASI is a composite index with scores ranging from 0 to 72. Higher values indicate more severe or extensive disease.'}], 'secondaryOutcomes': [{'measure': 'Investigator Global Assessment (IGA)', 'timeFrame': '12 weeks', 'description': 'The IGA assesses the overall appearance and severity of atopic dermatitis using a 5-point scale \\[0 (clear) to 4 (severe)\\].'}, {'measure': 'Body Surface Area (BSA)', 'timeFrame': '12 weeks', 'description': 'BSA estimates the extent of atopic dermatitis involvement and is expressed as a percentage of total body surface area.'}, {'measure': 'Pruritus-NRS', 'timeFrame': '12 weeks', 'description': 'The pruritus-NRS is an 11-point scale used by subjects to rate their worst itch severity over the past 24 hours with 0 indicating "no itch" and 10 indicating "worst itch imaginable".'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atopic dermatitis', 'eczema'], 'conditions': ['Atopic Dermatitis (AD)', 'Eczema', 'Eczema Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2a efficacy and safety study of EVO301 for the treatment of adults with atopic dermatitis.', 'detailedDescription': 'This is a Phase 2a efficacy and safety study of intravenous EVO301 in adults with moderate to severe atopic dermatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males or non-pregnant, non-lactating females, age 18 years or older\n2. Chronic atopic dermatitis for at least 6 months\n3. BSA of AD involvement of at least 10%\n4. EASI score of at least 16.\n\nExclusion Criteria:\n\n1. Significant AD flare with 4 weeks\n2. Use of biologic therapy within 12 weeks\n3. Regular use of tanning booth within 4 weeks\n4. Skin condition that could interfere with study assessments'}, 'identificationModule': {'nctId': 'NCT06723405', 'briefTitle': 'Efficacy Study of EVO301 in Moderate to Severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Evommune, Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study of EVO301 in Adults With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'EVO301-AD001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous EVO301', 'interventionNames': ['Biological: EVO301']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'EVO301', 'type': 'BIOLOGICAL', 'description': 'Intravenous EVO301', 'armGroupLabels': ['Intravenous EVO301']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'QLD 4151', 'city': 'Coorparoo', 'country': 'Australia', 'facility': 'Cornerstone Dermatology', 'geoPoint': {'lat': -27.49325, 'lon': 153.05826}}, {'zip': 'NSW 2010', 'city': 'Darlinghurst', 'country': 'Australia', 'facility': 'Momentum Clinical Research Darlinghurst', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '0622', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Pacific Clinical Research Network (PCRN) Auckland', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '0632', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Optimal Clinical Trials North', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '1010', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Optimal Clinical Trials', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '8013', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Pacific Clinical Research Network (PCRN) Christchurch', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '9016', 'city': 'Dunedin', 'country': 'New Zealand', 'facility': 'Momentum Clinical Research Dunedin', 'geoPoint': {'lat': -45.87416, 'lon': 170.50361}}, {'zip': '3204', 'city': 'Hamilton', 'country': 'New Zealand', 'facility': 'Clinical Trials New Zealand Ltd', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}, {'zip': '5010', 'city': 'Hutt Central', 'country': 'New Zealand', 'facility': 'Momentum Clinical Research Lower Hutt'}, {'zip': '7011', 'city': 'Nelson', 'country': 'New Zealand', 'facility': 'Pacific Clinical Research Network (PCRN) Tasman', 'geoPoint': {'lat': -41.27078, 'lon': 173.28404}}, {'zip': '5032', 'city': 'Paraparaumu', 'country': 'New Zealand', 'facility': 'Momentum Clinical Research Kapiti', 'geoPoint': {'lat': -40.91667, 'lon': 175.01667}}, {'zip': '2120', 'city': 'Pukekohe', 'country': 'New Zealand', 'facility': 'Momentum Clinical Research Pukekohe', 'geoPoint': {'lat': -37.20196, 'lon': 174.90363}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Evommune, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}