Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-26 @ 4:55 PM
Study NCT ID:
NCT06224192
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2024-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study With Self-administered Rocatinlimab in Adolescent and 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'}], '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-06', 'studyFirstSubmitDate': '2024-01-17', 'studyFirstSubmitQcDate': '2024-01-17', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Full-dose Self-administered Rocatinlimab Injections Among Total Attempted Injections up to Week 16', 'timeFrame': 'Up to Week 16'}], 'secondaryOutcomes': [{'measure': 'Proportion of Devices that Have Been Reported with Product Complaints Related to Function by Participants, Caregivers, or Investigators Among Total Dispensed Devices up to Week 16', 'timeFrame': 'Up to Week 16'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '40012373', 'type': 'BACKGROUND', 'citation': 'Guttman-Yassky E, Simpson E, Bissonnette R, Eichenfield LF, Kabashima K, Luna PC, Hercogova JT, Spelman L, Worm M, Esfandiari E, Arai T, Mano H, Charuworn P, Wang A, Kricorian G. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025 Feb;17(2):83-94. doi: 10.1080/1750743X.2025.2464528. Epub 2025 Feb 26.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneously using devices for injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 12 at Day 1.\n* Diagnosis of AD according to American Academy of Dermatology (AAD) Consensus Criteria (2014) that has been present for at least 12 months.\n* History of inadequate response to Topical Corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors \\[TCI\\]).\n* Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) score ≥ 3 at screening and pre-randomization.\n* Eczema Area and Severity Index (EASI) score ≥ 16 at initial at screening and pre-randomization.\n* ≥ 10% body surface area (BSA) of AD involvement at screening and pre-randomization.\n\nExclusion Criteria:\n\n* Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 pre-randomization.\n* Treatment with any of the following medications or therapies within 5 half-lives prior to day 1 pre-randomization:\n\n 1. Systemic corticosteroids\n 2. Non-biologic, non-targeted systemic immunosuppressants\n 3. Oral or Topical Janus kinase inhibitors\n* Treatment with any of the following medications or therapies within 1 week before day 1 pre-randomization:\n\n 1. Topical phosphodiesterase 4 (PDE4) inhibitors\n 2. Other topical immunosuppressive agents (not including TCS/TCI)\n 3. Combination topical agents containing any of the above components'}, 'identificationModule': {'nctId': 'NCT06224192', 'acronym': 'ROCKET-Outpost', 'briefTitle': 'A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Open-label, Performance Study With Self-administered Subcutaneous Rocatinlimab (AMG 451) in Adolescent and Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Outpost)', 'orgStudyIdInfo': {'id': '20230180'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rocatinlimab Dose 1 Prefilled Syringe (PFS)', 'description': 'Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab for 52 weeks.', 'interventionNames': ['Combination Product: Rocatinlimab Prefilled Syringe']}, {'type': 'EXPERIMENTAL', 'label': 'Rocatinlimab Dose 2 PFS', 'description': 'Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab for 52 weeks.', 'interventionNames': ['Combination Product: Rocatinlimab Prefilled Syringe']}, {'type': 'EXPERIMENTAL', 'label': 'Rocatinlimab Dose 2 Autoinjector (AI)', 'description': 'Rocatinlimab will be self-administered subcutaneously using an AI. Participants will received rocatinlimab for 52 weeks.', 'interventionNames': ['Combination Product: Rocatinlimab AI']}], 'interventions': [{'name': 'Rocatinlimab Prefilled Syringe', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['AMG 451'], 'description': 'Prefilled Syringe (PFS) for subcutaneous (SC) injection self-administration of rocatinlimab.', 'armGroupLabels': ['Rocatinlimab Dose 1 Prefilled Syringe (PFS)', 'Rocatinlimab Dose 2 PFS']}, {'name': 'Rocatinlimab AI', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['AMG 451'], 'description': 'AI for SC injection self-administration of rocatinlimab.', 'armGroupLabels': ['Rocatinlimab Dose 2 Autoinjector (AI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93301', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Kern Research Inc', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90805', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach Research Institute', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Research Associates', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Havana Research Institute Inc', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Integrative Skin Science and Research', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Direct Helpers Research Center', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Anchor Medical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30022', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Hamilton Research, LLC', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '83706', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Treasure Valley Medical Research', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '66211', 'city': 'Leawood', 'state': 'Kansas', 'country': 'United States', 'facility': 'Dermatology and Skin Cancer Center Leawood', 'geoPoint': {'lat': 38.96667, 'lon': -94.6169}}, {'zip': '89109', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Excel Clinical Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89030', 'city': 'North Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Las Vegas Clinical Trials', 'geoPoint': {'lat': 36.19886, 'lon': -115.1175}}, {'zip': '89509', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Skin Cancer and Dermatology Institute', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Skin Surgery Center for Clinical Research', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43209', 'city': 'Bexley', 'state': 'Ohio', 'country': 'United States', 'facility': 'Bexley Dermatology Research', 'geoPoint': {'lat': 39.96895, 'lon': -82.93768}}, {'zip': '44124', 'city': 'Mayfield Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Apex Clinical Research Center LLC', 'geoPoint': {'lat': 41.51922, 'lon': -81.4579}}, {'zip': '74137', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Essential Medical Research LLC', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '57702', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Health Concepts', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '37076', 'city': 'Hermitage', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Cumberland Skin Center', 'geoPoint': {'lat': 36.19617, 'lon': -86.6225}}, {'zip': '75149', 'city': 'Mesquite', 'state': 'Texas', 'country': 'United States', 'facility': 'Sms Clinical Research Limited Liability Company', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'zip': '75025', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Dermatology Research Center', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Dermatology and Skin Cancer Center', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': 'V1W 4V5', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Interior Dermatology Centre', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'L8L 3C3', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LEADER Research', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L3P 1X3', 'city': 'Markham', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Lynderm Research Inc', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}, {'zip': 'L4Y 4C5', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'DermEdge Research Incorporated', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L2H 1H5', 'city': 'Niagara Falls', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Allergy Research Canada Incorporated', 'geoPoint': {'lat': 43.10012, 'lon': -79.06627}}, {'zip': 'P1B 3Z7', 'city': 'North Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'North Bay Dermatology Centre', 'geoPoint': {'lat': 46.3168, 'lon': -79.46633}}, {'zip': 'K2C 3N2', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dermatology Ottawa Research Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M4E 1R7', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'FACET Dermatology', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N2J 1C4', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Alliance Clinical Trials', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'zip': 'N8T 1E6', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'XLR8 Medical Research, Incorporated', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'S7K 2C1', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Skinsense Medical Research', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'zip': '812-0013', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Ekihigashi Dermatology Allergy Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '814-0180', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Fukuoka University Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '819-0373', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Matsuo Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '862-0950', 'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Suizenji Dermatology Clinic', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '593-8324', 'city': 'Sakai-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Dermatology and Ophthalmology Kume Clinic'}, {'zip': '108-0014', 'city': 'Minato-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Mita Dermatology Clinic'}, {'zip': '160-8582', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Keio University Hospital'}, {'zip': '15355', 'city': 'Ansan-si, Gyeonggi-do', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital'}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05278', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Hospital at Gangdong', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'The Catholic University of Korea Seoul St Marys Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07441', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hallym University Kangnam Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '16499', 'city': 'Suwon-si, Gyeonggi-do', 'country': 'South Korea', 'facility': 'Ajou University Hospital'}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'ipdSharingStatementModule': {'url': 'http://www.amgen.com/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}