Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:43 PM
Study NCT ID:
NCT07366034
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Masking applies to double-blind part of the trial.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Part A:\n\n* double-blind, placebo-controlled in children from 6 to less than 18 years of age\n* and open-label active treatment in children from 2 to less than 6 years of age\n\nPart B:\n\n\\- open-label phase with active treatment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2031-04-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-01-23', 'studyFirstSubmitQcDate': '2026-01-23', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-04-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the concentration curve (AUC) T,SS based on sampling at steady state using rich sampling in participants from 6 years to less than 18 years and sparse sampling in participants younger than 6 years', 'timeFrame': 'At week 2 in Part A and Week 28 in Part B'}, {'measure': 'Occurrence of a treatment-emergent adverse event', 'timeFrame': 'up to Week 26'}], 'secondaryOutcomes': [{'measure': 'Absolute change from baseline in oxygen saturation (SpO2) [%] on room air at rest', 'timeFrame': 'at Week 26 and Week 52'}, {'measure': 'Absolute change from baseline in height [cm]', 'timeFrame': 'at Week 26 and Week 52'}, {'measure': 'Absolute change from baseline in pediatric quality of life inventory (PedsQL™)', 'timeFrame': 'at Week 26 and Week 52', 'description': 'Health-related quality of life will be assessed in children using the PedsQL™ questionnaire. For younger children who are unable to perform self-assessment, a parent proxy may be required. The score ranges from 0-100, a higher score indicates a better health related quality of life.'}, {'measure': 'Occurrence of a treatment-emergent adverse event (Yes/No) over the whole trial', 'timeFrame': 'up to 5 years'}, {'measure': 'Time to first respiratory-related hospitalisation [days] over the whole trial', 'timeFrame': 'up to 5 years'}, {'measure': 'Time to first acute interstitial lung disease (ILD) exacerbation or death [days] over the whole trial', 'timeFrame': 'up to 5 years'}, {'measure': 'Time to death [days] over the whole trial', 'timeFrame': 'up to 5 years'}, {'measure': 'Participant acceptability based on number/size of tablets', 'timeFrame': 'at Week 2 and Week 26', 'description': 'Acceptability is defined as the overall ability and willingness of the participant to use the medicinal product as intended.\n\nAssessment of acceptability will be performed by the participant using the acceptability questionnaire.'}, {'measure': 'Participant acceptability based on the use of the dispenser', 'timeFrame': 'at Week 2 and Week 26'}, {'measure': 'Absolute change from baseline in FVC [% predicted] (applicable to participants ≥6 years)', 'timeFrame': 'at Week 26 and Week 52'}, {'measure': 'Absolute change from baseline in 6-min walk distance [m] (applicable to participants ≥6 years)', 'timeFrame': 'at Week 26 and Week 52'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fibrosing Interstitial Lung Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.clinicalstudies.boehringer-ingelheim.com/msw/datatransparency', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "This study is open to children and adolescents aged 2 to 17 years with interstitial lung disease (ILD). Nerandomilast has just been approved in some countries to help adults with a lung condition called idiopathic pulmonary fibrosis. The purpose of this study is to understand how nerandomilast is tolerated and handled by the body and whether nerandomilast also helps children and adolescents with ILD.\n\nFor participants aged 6 to 17 years when joining, the study has 2 parts. In the first part, participants are put into 1 of 2 groups randomly, which means by chance. One group gets nerandomilast and the other group placebo. Placebo looks like nerandomilast but does not contain any medicine.\n\nParticipants are twice as likely to be in the nerandomilast group. They take tablets twice a day for 6 months. After these 6 months, in the second part of this study, they get nerandomilast for at least 2 years regardless of what they got in the first part.\n\nYoung participants aged 2 to 5 years when joining get nerandomilast from the start. They receive tablets twice a day for at least 2 and a half years.\n\nDepending on when a person joins, the study lasts between 2 and a half years and up to 5 years. During this time, participants may visit the study site about 18 to 30 times. Study doctors collect blood samples to check participants' health and to find out how their body handles the study medicine. Doctors also check the function of the lungs, body growth, and how participants feel. The study doctors also regularly check participants' health and take note of any changes. For participants aged 6 to 17 years, the results are compared between the groups to see whether nerandomilast treatment helps children and adolescents."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children and adolescents 2 to \\<18 years old at Visit 2.\n* Participants with evidence of fibrosing ILD on high-resolution computed tomography (HRCT) within 12 months of Visit 1 as assessed by the investigator and confirmed by central review.\n* For children ≥6 years: Participants with forced vital capacity (FVC) % predicted ≥25% at Visit 2.\n* Participants with clinically significant fibrosing ILD at Visit 2, as assessed by the investigator based on any of the following:\n\n * Fan score ≥3, or\n * Documented evidence of clinical progression over time based on either\n\n * a 5-10% relative decline in FVC % predicted accompanied by worsening symptoms, or\n * a ≥10% relative decline in FVC % predicted, or\n * increased fibrosis on HRCT, or\n * other measures of clinical worsening attributed to progressive lung disease (e.g. increased oxygen requirement, decreased diffusion capacity).\n\nFurther inclusion criteria apply.\n\nExclusion Criteria:\n\n* Previous treatment with nerandomilast.\n* Participants treated with other oral/systemic PDE4 and non-selective PDE inhibitors within 30 days before Visit 1.\n* Participants treated with pirfenidone in the 8 weeks prior to Visit 1.\n* Unstable pulmonary arterial hypertension (PAH).\n* Active vasculitis, unstable or uncontrolled within 8 weeks prior to Visit 1 or during the screening period.\n* Any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour) in the past (lifetime).\n* Any suicidal ideation of type 4 or 5 on the columbia suicidal severity rating scale (C-SSRS) in the past 3 months at Visit 1 or at Visit 2 (i.e. active suicidal thought with method and intent but without specific plan; or active suicidal thought with method, intent, and plan).\n* Participants with clinically significant depression symptoms defined as the short version of mood and feeling questionnaire (SMFQ) score ≥8.\n\nFurther exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT07366034', 'briefTitle': 'A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Study to Evaluate the Dose-exposure, Safety, and Exploratory Efficacy of Nerandomilast in Children and Adolescents From 2 Years to Less Than 18 Years of Age With Fibrosing Interstitial Lung Disease (Part A: Double-blind, Placebo-controlled in Children From 6 to Less Than 18 Years of Age and Open-label Active Treatment in Children From 2 to Less Than 6 Years of Age), Followed by an Open-label Phase With Active Treatment (Part B)', 'orgStudyIdInfo': {'id': '1305-0022'}, 'secondaryIdInfos': [{'id': '2025-523369-32-00', 'type': 'REGISTRY', 'domain': 'CTIS'}, {'id': '1111-1326-6351', 'type': 'REGISTRY', 'domain': 'WHO - International Clinical Trials Registry Platform (ICTRP)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants aged 2 to <6 years', 'description': 'Part A and Part B: Nerandomilast (open-label)', 'interventionNames': ['Drug: Nerandomilast']}, {'type': 'EXPERIMENTAL', 'label': 'Participants aged 6 to <18 years, group 1', 'description': 'Part A: Nerandomilast (blinded), Part B: Nerandomilast (open-label)', 'interventionNames': ['Drug: Nerandomilast']}, {'type': 'EXPERIMENTAL', 'label': 'Participants aged 6 to <18 years, group 2', 'description': 'Part A: Placebo (blinded), Part B: Nerandomilast (open-label)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Nerandomilast', 'type': 'DRUG', 'otherNames': ['JASCAYD®'], 'description': 'Nerandomilast', 'armGroupLabels': ['Participants aged 2 to <6 years', 'Participants aged 6 to <18 years, group 1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Participants aged 6 to <18 years, group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '1426', 'city': 'CABA', 'country': 'Argentina', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'argentina@bitrialsupport.com', 'phone': '08002667801'}], 'facility': 'Fundacion Respirar'}, {'zip': 'C1245AAM', 'city': 'CABA', 'country': 'Argentina', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'argentina@bitrialsupport.com', 'phone': '08002667801'}], 'facility': 'Hospital de Pediatria Prof. Dr. Juan P. Garrahan'}, {'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'belgique@bitrialsupport.com', 'phone': '080049616'}], 'facility': 'Brussels - UNIV HUDERF', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '27323240', 'city': 'Barra Mansa', 'country': 'Brazil', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'brasil@bitrialsupport.com', 'phone': '08008919295'}], 'facility': 'Serviços Medicos Respirar Sul Fluminense', 'geoPoint': {'lat': -22.54417, 'lon': -44.17139}}, {'zip': '90160-093', 'city': 'Porto Alegre', 'country': 'Brazil', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'brasil@bitrialsupport.com', 'phone': '08008919295'}], 'facility': 'Associação dos Funcionários Públicos do Estado do Rio Grande do Sul - Hospital Ernesto Dorneles', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '50070-550', 'city': 'Recife', 'country': 'Brazil', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'brasil@bitrialsupport.com', 'phone': '08008919295'}], 'facility': 'IMIP Pernambuco', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'zip': '5403-900', 'city': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'brasil@bitrialsupport.com', 'phone': '08008919295'}], 'facility': 'Centro de Pesquisa Clinica do Instituto da Crianca - HCFMUSP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'canada@bitrialsupport.com', 'phone': '18336022346'}], 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '100045', 'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'china@bitrialsupport.com', 'phone': '4001200553'}], 'facility': "Beijing Children's Hospital, Capital Medical University", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '410005', 'city': 'Changsha', 'country': 'China', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'china@bitrialsupport.com', 'phone': '4001200553'}], 'facility': "Hunan Provincial People's Hospital", 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '201102', 'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'china@bitrialsupport.com', 'phone': '4001200553'}], 'facility': "The Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '150 00', 'city': 'Prague', 'country': 'Czechia', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'cesko@bitrialsupport.com', 'phone': '800142046'}], 'facility': 'University Hospital Motol', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '8200', 'city': 'Aarhus N', 'country': 'Denmark', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'danmark@bitrialsupport.com', 'phone': '80711822'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}, {'zip': 'PL 281, 00029', 'city': 'Helsinki', 'country': 'Finland', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'suomi@bitrialsupport.com', 'phone': '0800918118'}], 'facility': 'HUS Lasten ja nuorten sairaudet, Kliinisen tutkimuksen yksikkö', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '33520', 'city': 'Tampere', 'country': 'Finland', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'suomi@bitrialsupport.com', 'phone': '0800918118'}], 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '69677', 'city': 'Bron', 'country': 'France', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'france@bitrialsupport.com', 'phone': '0805102354'}], 'facility': 'HOP Femme Mère Enfant', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '94000', 'city': 'Créteil', 'country': 'France', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'france@bitrialsupport.com', 'phone': '0805102354'}], 'facility': 'HOP Intercommunal', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '13387', 'city': 'Marseille', 'country': 'France', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'france@bitrialsupport.com', 'phone': '0805102354'}], 'facility': 'HOP Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'france@bitrialsupport.com', 'phone': '0805102354'}], 'facility': 'HOP Armand-Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'france@bitrialsupport.com', 'phone': '0805102354'}], 'facility': 'HOP Necker - Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'deutschland@bitrialsupport.com', 'phone': '08007234742'}], 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '22081', 'city': 'Hamburg', 'country': 'Germany', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'deutschland@bitrialsupport.com', 'phone': '08007234742'}], 'facility': 'Hamburger Zentrum für Kinder- und Jugendrheumatologie', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'deutschland@bitrialsupport.com', 'phone': '08007234742'}], 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '54642', 'city': 'Thessaloniki', 'country': 'Greece', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'hellas@bitrialsupport.com', 'phone': '008000000092'}], 'facility': 'Aristotle University, Thessaloniki', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '16147', 'city': 'Genova', 'country': 'Italy', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'italia@bitrialsupport.com', 'phone': '800977373'}], 'facility': 'Istituto G. Gaslini', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '00165', 'city': 'Roma', 'country': 'Italy', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'italia@bitrialsupport.com', 'phone': '800977373'}], 'facility': 'Osp. Pediatrico Bambin Gesù', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '813-0017', 'city': 'Fukuoka, Fukuoka', 'country': 'Japan', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'nippon@bitrialsupport.com', 'phone': '05050508862'}], 'facility': "Fukuoka Children's Hospital"}, {'zip': '594-1101', 'city': 'Osaka, Izumi', 'country': 'Japan', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'nippon@bitrialsupport.com', 'phone': '05050508862'}], 'facility': "Osaka Women's and Children's Hospital"}, {'zip': '157-8535', 'city': 'Tokyo, Setagaya-ku', 'country': 'Japan', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'nippon@bitrialsupport.com', 'phone': '05050508862'}], 'facility': 'National Center for Child Health and Development', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '44340', 'city': 'Guadalajara', 'country': 'Mexico', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'mexico@bitrialsupport.com', 'phone': '018000623749'}], 'facility': 'Centro de Investigacion Clinica y Medicina Traslacional (CIMeT)', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'nederland@bitrialsupport.com', 'phone': '08000204613'}], 'facility': 'Amsterdam University Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '02 091', 'city': 'Warsaw', 'country': 'Poland', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'polska@bitrialsupport.com', 'phone': '008001218830'}], 'facility': 'University Clinical Center of the Medical University of Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '1649-035', 'city': 'Lisbon', 'country': 'Portugal', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'portugal@bitrialsupport.com', 'phone': '800856070'}], 'facility': 'ULS de Santa Maria, E.P.E', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'espana@bitrialsupport.com', 'phone': '900876092'}], 'facility': 'Hospital Universitari Vall D Hebron', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'espana@bitrialsupport.com', 'phone': '900876092'}], 'facility': 'Hospital Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127'}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.', 'ipdSharing': 'YES', 'description': 'Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".\n\nFurthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.', 'accessCriteria': "For study documents - upon signing of a 'Document Sharing Agreement'.\n\nFor study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}