Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT05717920
Status:
COMPLETED
Last Update Posted:
2024-11-04
First Post:
2023-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial in Subjects With Atopic Dermatitis (Part 1)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000716647', 'term': 'ADX-629'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Part 1 is an open-label trial.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'dispFirstSubmitDate': '2024-10-30', 'completionDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2023-01-25', 'studyFirstSubmitQcDate': '2023-02-06', 'dispFirstPostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Event (AE) Query', 'timeFrame': 'From Day 1 to Day 90', 'description': 'Incidence and severity of AEs'}], 'secondaryOutcomes': [{'measure': 'Investigator Global Assessment (IGA) Score', 'timeFrame': 'From Day 1 to Day 90', 'description': 'Change from Baseline in IGA Score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eczema', 'atopic', 'adaptive', 'Aldeyra', 'ADX-629', 'Reactive aldehyde species (RASP)'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'A Phase 2, multicenter, adaptive 2-part clinical trial designed to evaluate the safety and efficacy of ADX-629 alone and in combination with standard-of-care in adults with atopic dermatitis.', 'detailedDescription': 'The trial is divided into 2 parts; the first part of the trial (Part 1) is open label, and the second part (Part 2) is randomized, double-blind, and placebo controlled.\n\nIn Part 1, approximately 10 subjects will receive open-label ADX-629 twice daily for 90 days.\n\nIn Part 2, approximately 40 subjects will be randomized to receive either ADX-629 or matching placebo twice daily for 90 days.\n\nPatients who are interested in participating will be provided detailed information about the study including description of study assessments/procedures, possible side-effects, alternative treatments, and potential benefits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥18 years of age\n* History of atopic dermatitis, according to American Academy of Dermatology criteria, that has been present for at least 6 months\n* Mild, moderate, or severe atopic dermatitis, defined as an IGA score of ≥2 at Baseline\n* Not pregnant, breastfeeding, or lactating and agree to use a highly effective method of acceptable contraceptive for the trial duration, if applicable\n\nExclusion Criteria:\n\n* Presence of clinically significant kidney disease or an estimated gloverular filtration rate (eGFR) of less than or equal to 45 milliliters/min/1.73 m2 during screening\n* History of any unstable chronic diseases/conditions, clinically significant abnormalities, or findings, that in the opinion of the Investigator, could compromise subject safety or affect the conduct of the trial'}, 'identificationModule': {'nctId': 'NCT05717920', 'briefTitle': 'A Clinical Trial in Subjects With Atopic Dermatitis (Part 1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aldeyra Therapeutics, Inc.'}, 'officialTitle': 'The ADRO Trial: An Adaptive, 2-Part, Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Adults With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'ADX-629-ATD-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADX-629', 'interventionNames': ['Drug: ADX-629 (Open-label)']}], 'interventions': [{'name': 'ADX-629 (Open-label)', 'type': 'DRUG', 'description': 'ADX-629 (250 mg) administered twice daily for 90 days', 'armGroupLabels': ['ADX-629']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43209', 'city': 'Bexley', 'state': 'Ohio', 'country': 'United States', 'facility': 'Bexley Dermatology Research', 'geoPoint': {'lat': 39.96895, 'lon': -82.93768}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aldeyra Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}