Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-01-02 @ 11:42 PM
Study NCT ID:
NCT05048056
Status:
TERMINATED
Last Update Posted:
2025-02-26
First Post:
2021-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2 Study of Efficacy and Safety of AK120, in Subjects 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'}], '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double Blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'whyStopped': 'Clinical study and development strategy adjustment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2021-09-09', 'studyFirstSubmitQcDate': '2021-09-09', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects achieving an Eczema Area and Severity Index (EASI) 75 response', 'timeFrame': 'At week 16'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects achieving the Investigator Global Assessment (IGA, on a 5-point scale) for clear (0) or almost clear (1)', 'timeFrame': 'At week 16'}, {'measure': 'Change in SCORing Atopic Dermatitis (SCORAD)', 'timeFrame': 'Baseline to Week 38'}, {'measure': 'Change in Pruritus-Numerical Rating Scale (P-NRS)', 'timeFrame': 'Baseline to Week 38'}, {'measure': 'Change in Body Surface Area (BSA) of AD involvement', 'timeFrame': 'Baseline to Week 38'}, {'measure': 'Change in Patient Oriented Eczema Measure (POEM)', 'timeFrame': 'Baseline to Week 38'}, {'measure': 'Individual subject AK120 concentrations in serum at different time points after AK120 administration', 'timeFrame': 'Baseline to Week 38'}, {'measure': 'Change in pharmacodynamics studies TARC/CCL17 and IgE', 'timeFrame': 'Baseline to week 24'}, {'measure': 'Anti-drug antibodies(ADAs)', 'timeFrame': 'Baseline to Week 38'}, {'measure': 'Adverse events(AEs)/serious adverse events(SAEs)', 'timeFrame': 'Baseline to Week 38'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atopic Dermatitis', 'Monoclonal Antibodies'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This is a phase 2, multi-center, randomized, placebo-controlled, double-blind, parallel-group, dose-ranging study, conducted in subjects with moderate-to-severe atopic dermatitis.', 'detailedDescription': 'This phase 2 study is designed to explore the efficacy and safety, as well as pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of dose-ranging AK120 compared to placebo, which will generate information regarding the selection of dosing regimens with AK120 monotherapy treatment in adult subjects with moderate-to-severe AD.\n\nPrimary Objectives:\n\n• To evaluate the efficacy of AK120 in the treatment of adult subjects with moderate-to-severe Atopic Dermatitis (AD).\n\nSecondary Objectives:\n\n* To evaluate the safety of AK120 in the treatment of adult subjects with moderate-to-severe AD.\n* To evaluate the Pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of AK120 in adult subjects with moderate-to-severe AD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Male or female, over the age of 18\n2. Chronic atopic dermatitis (AD) diagnosed at least 1 year.\n3. Subject with EASI score ≥16, IGA ≥ 3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe), ≥ 10% body surface area (BSA) of AD involvement.\n4. Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months.\n\nKey Exclusion Criteria:\n\n1. Inadequate washout period for prior drug therapy (eg. corticosteroids, immunosuppressive/ immunomodulating, biologics, phototherapy, Chinese traditional medicine, anti-infective agents).\n2. History of exposure to active TB, and/or history or current evidence of TB infection.\n3. Positive serology results at Screening for hepatitis B, hepatitis C or HIV.\n4. Any history of vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC) within 6 months before the baseline visit.\n5. History of clinical parasite infection, recent or planned travel to an area with endemic parasite infection within 6 months before the Screening visit\n6. Any medical or psychiatric condition, laboratory, or ECG parameter which, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with participation in the study, or interfere with the interpretation of study results."}, 'identificationModule': {'nctId': 'NCT05048056', 'briefTitle': 'Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akeso'}, 'officialTitle': 'A Phase 2, Multi-center, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of AK120 in Adult Subjects With Moderate-to-Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'AK120-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AK120 Regimen 1', 'description': 'AK120 Regimen 1- subcutaneous injection every 2 weeks for 30 weeks.', 'interventionNames': ['Drug: AK120']}, {'type': 'EXPERIMENTAL', 'label': 'AK120 Regimen 2', 'description': 'AK120 Regimen 2- subcutaneous injection every 2 weeks for 30 weeks.', 'interventionNames': ['Drug: AK120']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo to AK120', 'description': 'Placebo subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 1, subcutaneous injection at Week16, after primary endpoint evaluation', 'interventionNames': ['Drug: Placebo', 'Drug: AK120']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo subcutaneous injection every 2 weeks for 16 weeks then Crossover to AK120 Regimen 1', 'armGroupLabels': ['Placebo to AK120']}, {'name': 'AK120', 'type': 'DRUG', 'description': 'AK120 Regimen 1- subcutaneous injection every 2 weeks.', 'armGroupLabels': ['AK120 Regimen 1', 'Placebo to AK120']}, {'name': 'AK120', 'type': 'DRUG', 'description': 'AK120 Regimen 2- subcutaneous injection every 2 weeks', 'armGroupLabels': ['AK120 Regimen 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72204', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'AkesoBio Investigative Site 2003', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91303', 'city': 'Canoga Park', 'state': 'California', 'country': 'United States', 'facility': 'AkesoBio Investigative Site 2010', 'geoPoint': {'lat': 34.20112, 'lon': -118.59814}}, {'zip': '92119', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'AkesoBio Investigative Site 2021', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'AkesoBio Investigative Site 2023', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94127', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'AkesoBio Investigative Site 2017', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '91043', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'AkesoBio Investigative Site 2020', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'AkesoBio Investigative Site 2009', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'AkesoBio Investigative Site 2001', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'AkesoBio Investigative Site 2011', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'AkesoBio Investigative Site 2002', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '39157', 'city': 'Ridgeland', 'state': 'Mississippi', 'country': 'United States', 'facility': 'AkesoBio Investigative Site 2022', 'geoPoint': {'lat': 32.42848, 'lon': -90.13231}}, {'zip': '89145', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'AkesoBio Investigative Site 2015', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'AkesoBio Investigative Site 2013', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '57702', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'AkesoBio Investigative Site 2005', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '77065', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'AkesoBio Investigative Site 2004', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'AkesoBio Investigative Site 2018', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '2145', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'AkesoBio Investigative Site 3003', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'AkesoBio Investigative Site 3002', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '3145', 'city': 'Camberwell', 'state': 'Victoria', 'country': 'Australia', 'facility': 'AkesoBio Investigative Site 3001', 'geoPoint': {'lat': -37.84205, 'lon': 145.0694}}, {'zip': '0626', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'AkesoBio Investigative Site 4003', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '1010', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'AkesoBio Investigative Site 4001', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '8013', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'AkesoBio Investigative Site 4005', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '3204', 'city': 'Hamilton', 'country': 'New Zealand', 'facility': 'AkesoBio Investigative Site 4004', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}, {'zip': '6242', 'city': 'Wellington', 'country': 'New Zealand', 'facility': 'AkesoBio Investigative Site 4004', 'geoPoint': {'lat': -41.28664, 'lon': 174.77557}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akesobio Australia Pty Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}