Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-30 @ 11:31 PM
Study NCT ID:
NCT05626751
Status:
TERMINATED
Last Update Posted:
2025-03-12
First Post:
2022-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'France', 'Germany', 'Switzerland'], 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-12'}], 'estimatedResultsFirstSubmitDate': '2025-12-12'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D045743', 'term': 'Scleroderma, Diffuse'}, {'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'whyStopped': 'Decision to terminate is due to the parent trial (HZNP-HZN-825-301) meeting pre-defined criteria for futility', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2022-11-01', 'studyFirstSubmitQcDate': '2022-11-15', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from trial baseline, defined as the latest measurement prior to the first dose of HZN-825 in FVC % predicted', 'timeFrame': 'Baseline to Week 52', 'description': 'As measured by a pulmonary function test called a spirometry.'}, {'measure': 'Change from HZN-825 Baseline, defined as the latest measurement prior to the first dose of HZN-825 in either trial HZNP-HZN-825-301 or this extension trial in FVC % predicted', 'timeFrame': 'Baseline to Week 52', 'description': 'As measured by a pulmonary function test called a spirometry.'}, {'measure': 'Incidence of treatment emergent adverse events (TEAEs)', 'timeFrame': 'Day 1 to Week 56'}, {'measure': 'Incidence of adverse events of special interest (AESI) orthostatic hypotension', 'timeFrame': 'Day 1 to Week 52'}, {'measure': 'Incidence and frequency of use of concomitant medication', 'timeFrame': 'Day 1 to Week 56'}, {'measure': 'Change from trial baseline in vital signs as reported as TEAEs', 'timeFrame': 'Day 1 to Week 56'}, {'measure': 'Change from HZN-825 baseline in vital signs as reported as TEAEs', 'timeFrame': 'Day 1 to Week 56'}, {'measure': 'Change from trial baseline in abnormal and clinically significant 12-lead electrocardiogram (ECG) measurements.', 'timeFrame': 'Baseline to Week 52', 'description': "Clinically significant changes in ECGs is defined as any clinical significant difference in heart rate, RR interval, PR interval, QRS, and QT interval corrected using Fridericia's formula (QTcF)."}, {'measure': 'Change from HZN-825 trial baseline in abnormal and clinically significant 12-lead ECG measurements.', 'timeFrame': 'Baseline to Week 52', 'description': "Clinically significant changes in ECGs is defined as any clinical significant difference in heart rate, RR interval, PR interval, QRS, and QT interval corrected using Fridericia's formula (QTcF)."}, {'measure': 'Change from trial baseline in abnormal laboratory test results', 'timeFrame': 'Day 1 to Week 56', 'description': 'Clinically significant lab values in serum chemistry, hematology, lipids, coagulation tests and urinalyses will be assessed (including Grade 3 or higher per common terminology criteria for adverse events)'}, {'measure': 'Change from HZN-825 baseline in abnormal laboratory test results', 'timeFrame': 'Day 1 to Week 56', 'description': 'Clinically significant lab values in serum chemistry, hematology, lipids, coagulation tests and urinalyses will be assessed (including Grade 3 or higher per common terminology criteria for adverse events)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Scleroderma', 'Forced vital capacity'], 'conditions': ['Diffuse Cutaneous Systemic Sclerosis', 'Sclerosis, Systemic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'Primary Objectives:\n\n1. The primary efficacy objective is to assess the efficacy of 52 weeks of open-label treatment with HZN-825 in participants with diffuse cutaneous systemic sclerosis, as measured by change from both baselines in forced vital capacity percent (FVC %) predicted.\n2. The primary safety objective is to examine the safety and tolerability of 52 weeks of open-label treatment with HZN-825, inclusive of, but not limited to, adverse events (AEs), serious AEs (SAEs) and the adverse event of special interest (AESI), from Day 1 to 4 weeks after last dose.', 'detailedDescription': 'This is an open-label, repeat-dose, multicenter extension trial of HZNP-HZN-825-301. Participants who complete the double-blind Treatment Period (Week 52) in Trial HZNP-HZN-825-301 will be eligible to enter this 52-week extension trial. Participants entering this extension trial will complete the Week 52 Visit activities in HZNP-HZN-825-301 and will not complete the Safety Follow-up Visit 4 weeks after the last dose of trial drug in HZNP-HZN-825-301.\n\nAcquired from Horizon in 2024.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1\\. Completed the double-blind Treatment Period (Week 52) in Trial HZNP-HZN-825-301; participants prematurely discontinued from trial drug in Trial HZNP-HZN-825-301 for reasons other than safety or toxicity can be included at the discretion of the Investigator after completing Trial HZNP-HZN-825-301 scheduled visits, including Week 52 assessments.\n\nKey Exclusion Criteria:\n\n1. Anticipated use of another investigational agent for any condition during the course of the trial.\n2. New diagnosis of malignant condition after enrolling in Trial HZNP-HZN-825-301 (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ).\n3. Women of childbearing potential (WOCBP) or male participants not agreeing to use highly effective method(s) of birth control throughout the trial and for 4 weeks after last dose of trial drug as defined in the protocol.\n4. Any new development with the participant's disease or condition or any significant laboratory test abnormality during the course of Trial HZNP-HZN-825-301 that, in the opinion of the Investigator, would potentially put the subject at unacceptable risk.\n5. Pregnant or lactating women.\n6. Participants will be ineligible if, in the opinion of the Investigator, they are unlikely to comply with the trial protocol or have a concomitant disease or condition that could interfere with the conduct of the trial."}, 'identificationModule': {'nctId': 'NCT05626751', 'briefTitle': 'An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Multicenter, Open-label Extension Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis', 'orgStudyIdInfo': {'id': 'HZNP-HZN-825-302'}, 'secondaryIdInfos': [{'id': '2021-006271-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HZN-825', 'description': 'HZN-825 will be administered by mouth (PO) twice daily (BID) for 52 weeks', 'interventionNames': ['Drug: HZN-825']}], 'interventions': [{'name': 'HZN-825', 'type': 'DRUG', 'description': 'HZN-825 will be administered BID for 52 weeks', 'armGroupLabels': ['HZN-825']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032-9306', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Arthritis and Rheumatology Associates -4550 E Bell Rd', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90095-8344', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33136-1005', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33324-2736', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'IRIS Research and Development LLC', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '70115-3584', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'DelRicht Clinical Research, LLC - Internal - Covington - PPDS', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02118-2642', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University School Of Medicine', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109-5000', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Medicine University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic - Cancer Center - Rochester - PPDS', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '27710-3037', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '29425-8900', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina (MUSC) - PPDS', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77030-5400', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Physicians Rheumatology', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'B1900', 'city': 'La Plata', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Framingham Centro Médico', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'zip': 'C1426', 'city': 'Buenos Aires', 'state': 'Ciudad Autónoma de BuenosAires', 'country': 'Argentina', 'facility': 'Consultorio Médico Dra. Rivera', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'T4000AXL', 'city': 'San Miguel de Tucumán', 'state': 'Tucumán Province', 'country': 'Argentina', 'facility': 'Centro de Investigaciones Médicas Tucumán - PPDS', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': 'T4000AXL', 'city': 'San Miguel de Tucumán', 'state': 'Tucumán Province', 'country': 'Argentina', 'facility': 'Centro de Investigaciones Reumatológicas', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': 'T4000IHE', 'city': 'San Miguel de Tucumán', 'state': 'Tucumán Province', 'country': 'Argentina', 'facility': 'Clínica Mayo de U.M.C.B. S.R.L', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': 'C1406AGA', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Aprillus Asistencia e Investigacion de Arcis Salud SRL', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1430EGF', 'city': 'Cuiudad Autónoma de Buenos Aires', 'country': 'Argentina', 'facility': 'Clínica Adventista Belgrano'}, {'zip': 'M5500CPH', 'city': 'Mendoza', 'country': 'Argentina', 'facility': 'I.R. Medical Center - Hospital de Dia', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'zip': '7510047', 'city': 'Santiago', 'state': 'Región-MetropolitanadeSantiago', 'country': 'Chile', 'facility': 'Prosalud y Cia Ltda.', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '115 27', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'Laiko General Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '546 36', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Euromedica Kianous Stavros', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '546 42', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': "General Hospital of Thessaloniki ''Hippokratio''", 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '52621', 'city': 'Ramat Gan', 'state': 'Tel Aviv', 'country': 'Israel', 'facility': 'The Chaim Sheba Medical Center - PPDS', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '64239', 'city': 'Tel Aviv', 'state': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel Aviv Sourasky Medical Center Ichilov - PPDS', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Health Care Campus - PPDS', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '4910000', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Rabin Medical Center - PPDS', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '33100', 'city': 'Udine', 'state': 'Friuli Venezia Giulia', 'country': 'Italy', 'facility': 'Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'zip': '060-848', 'city': 'Sapporo', 'state': 'Hokkaidô', 'country': 'Japan', 'facility': 'Hokkaido University Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '060-8543', 'city': 'Sapporo', 'state': 'Hokkaidô', 'country': 'Japan', 'facility': 'Sapporo Medical University Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '852-8102', 'city': 'Nagasaki', 'state': 'Nagasaki', 'country': 'Japan', 'facility': 'Nagasaki University Hospital', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'zip': '350-0495', 'city': 'Iruma-Gun', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Medical University Hospital'}, {'zip': '113-8431', 'city': 'Bunkyo-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Juntendo University Hospital'}, {'zip': '113-8603', 'city': 'Bunkyo-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Nippon Medical School Hospital'}, {'zip': '569-8686', 'city': 'Takatsuki-Shi', 'state': 'Ôsaka', 'country': 'Japan', 'facility': 'Osaka Medical and Pharmaceutical University Hospital'}, {'zip': '44690', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Centro de Estudios de Investigacion Basica Y Clinica SC', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': 'ZC 44160', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Centro Integral Reumatologia SA de CV', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '14000', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '11850', 'city': 'San Miguel Chapultepec', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Centro de Investigación y Tratamiento Reumatológico S.C', 'geoPoint': {'lat': 19.41096, 'lon': -99.18776}}, {'zip': '78213', 'city': 'Burócratas Del Estado', 'state': 'San Luis Potosí', 'country': 'Mexico', 'facility': 'Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC'}, {'zip': '44600', 'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'Clinica de Investigacion en Reumatologia y Obesidad', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '97000', 'city': 'Mérida', 'country': 'Mexico', 'facility': 'Unidad de Atencion Medica e Investigacion en Salud', 'geoPoint': {'lat': 20.967, 'lon': -89.62318}}, {'zip': '6700', 'city': 'México', 'country': 'Mexico', 'facility': 'CITER, Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas SA de CV', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'zip': '30-149', 'city': 'Krakow', 'state': 'Lesser Poland Voivodeship', 'country': 'Poland', 'facility': 'Malopolskie Centrum Kliniczne', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '67-100', 'city': 'Nowa Sól', 'state': 'Lubusz Voivodeship', 'country': 'Poland', 'facility': 'Twoja Przychodnia NCM', 'geoPoint': {'lat': 51.80333, 'lon': 15.71702}}, {'zip': '00-874', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Medicover Integrated Clinical Services sp. z o.o - MICS - PPDS', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-665', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Centrum Medyczne Reuma Park NZOZ', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '1649-035', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital de Santa Maria-Avenida Prof. Egas Moniz - PPDS', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '011172', 'city': 'Bucharest', 'state': 'București', 'country': 'Romania', 'facility': 'Sf.Maria Clinical Hospital', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '20475', 'city': 'Bucharest', 'state': 'București', 'country': 'Romania', 'facility': 'Dr I Cantacuzino Clinical Hospital', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '500283', 'city': 'Brasov', 'country': 'Romania', 'facility': 'Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Institute of Rheumatology - PPDS', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '708120', 'city': 'Niška Banja', 'country': 'Serbia', 'facility': 'Institute for Treatment and Rehabilitation Niska Banja', 'geoPoint': {'lat': 43.29507, 'lon': 22.0057}}, {'zip': '61469', 'city': 'Gwangju', 'state': "Gwangju Gwang'yeogsi", 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '13620', 'city': 'Seongnam', 'state': 'Gyeonggido', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '04763', 'city': 'Seongdong-gu', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Hanyang University Seoul Hospital'}, {'zip': '06273', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'facility': 'Hospital Universitario Marques de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '15006', 'city': 'A Coruña', 'country': 'Spain', 'facility': 'Hospital Universitario A Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitario Vall d'Hebron - PPDS", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de La Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28009', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marañon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '41010', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Quironsalud Infanta Luisa', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46017', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario Doctor Peset', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'NW3 2QG', 'city': 'London', 'state': 'London, City of', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], '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'}}}}