Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-01-25 @ 9:28 PM
Study NCT ID:
NCT06585202
Status:
COMPLETED
Last Update Posted:
2025-04-29
First Post:
2024-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of ATI-2138 in Adult Participants 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': 'D004485', 'term': 'Eczema'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D012871', 'term': 'Skin Diseases'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2024-09-03', 'studyFirstSubmitQcDate': '2024-09-03', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of treatment emergent adverse events (TEAEs)', 'timeFrame': 'From baseline up to two weeks after treatment (Day 98)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline Eczema Area and Severity Index (EASI) Over Time', 'timeFrame': 'Up to Week 12'}, {'measure': 'Proportions of participants who achieve at least 50%, 75%, and 90% improvement in EASI Over Time', 'timeFrame': 'Up to Week 12'}, {'measure': "Proportion of participants achieving Investigator's Global Assessment-Treatment Success Over Time", 'timeFrame': 'Up to Week 12'}, {'measure': 'Change in IGA score over time', 'timeFrame': 'Up to Week 12'}, {'measure': 'Change from baseline in AD Body Surface Area (BSA) over time', 'timeFrame': 'Up to week 12'}, {'measure': 'Change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) over time', 'timeFrame': 'Up to Week 12'}, {'measure': 'ATI-2138 trough concentration ng/mL', 'timeFrame': 'Day 1 to Week 12'}, {'measure': 'ATI-2138 peak concentration (Cmax) ng/mL', 'timeFrame': 'Day 1 to Week 12'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eczema', 'Dermatitis', 'Dermatitis, Atopic', 'Skin Diseases, Eczematous', 'Skin Diseases'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2 open label study of ATI-2138 in participants with moderate to severe atopic dermatitis.', 'detailedDescription': 'This open-label, single-arm study of ATI-2138 in moderate to severe AD participants between the ages of 18 and 60 years (inclusive) will investigate the safety, tolerability, pharmacokinetics, efficacy and pharmacodynamics of ATI-2138 administered over 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to comprehend and willing to sign the IRB approved ICF/assent prior to administration of study-related procedures.\n* Male patients or non-pregnant, non-nursing female patients 18 to 60 years old, inclusive, at the time of informed consent/assent.\n* Have at least a 1-year history of moderate or severe AD prior to the Screening Visit, and no significant AD flares for the 4 weeks prior to the Screening Visit as determined by the Investigator upon review of participant medical history.\n\nExclusion Criteria:\n\n* Any prior exposure to systemic (oral) JAK inhibitors or TYK inhibitors at any time prior to Screening.\n* Unstable course of AD (spontaneously improving or rapidly deteriorating) based on the patient history or as determined by the investigator during the Screening Period.\n* Refractory AD (ie, AD that required frequent hospitalizations and/or frequent intravenous treatment for skin infections within the year before the Screening Visit).\n* Concomitant skin disease or clinically infected AD or presence of other skin disease in the area to be dosed that may interfere with study assessments.\n* Female patients who are pregnant, nursing, or planning to become pregnant during the study.'}, 'identificationModule': {'nctId': 'NCT06585202', 'briefTitle': 'Study of ATI-2138 in Adult Participants With Moderate to Severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aclaris Therapeutics, Inc.'}, 'officialTitle': 'A Phase 2a Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Efficacy, and Pharmacodynamics of ATI-2138 Administered Over 12 Weeks in Participants With Moderate to Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'ATI-2138-AD-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ATI-2138', 'description': 'ATI-2138 oral tablets BID', 'interventionNames': ['Drug: ATI-2138']}], 'interventions': [{'name': 'ATI-2138', 'type': 'DRUG', 'description': 'ATI-2138 Oral Tablets BID', 'armGroupLabels': ['ATI-2138']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35244', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Aclaris Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Aclaris Investigational Site', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Aclaris Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '46168', 'city': 'Plainfield', 'state': 'Indiana', 'country': 'United States', 'facility': 'Aclaris Investigational Site', 'geoPoint': {'lat': 39.70421, 'lon': -86.39944}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Aclaris Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78213', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Aclaris Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Ajay Aggarwal, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aclaris Therapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aclaris Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}