Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-01-01 @ 8:30 AM
Study NCT ID:
NCT04123795
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2019-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Children With Moderate to Severe Chronic Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068582', 'term': 'Certolizumab Pegol'}], 'ancestors': [{'id': 'D011092', 'term': 'Polyethylene Glycols'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D007140', 'term': 'Immunoglobulin Fab Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 49}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2034-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2019-10-09', 'studyFirstSubmitQcDate': '2019-10-09', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-09-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentrations of Certolizumab pegol (CZP) at Week 16', 'timeFrame': 'Week 16', 'description': 'Blood samples will be collected for measurement of plasma concentrations of CZP at Week 16.'}, {'measure': 'Plasma anti-CZP antibody titers at Week 16', 'timeFrame': 'Week 16', 'description': 'Blood samples will be collected for measurement of anti-CZP antibody titers at Week 16.'}, {'measure': 'Plasma concentrations of CZP at Week 52', 'timeFrame': 'Week 52', 'description': 'Blood samples will be collected for measurement of plasma concentrations of CZP at Week 52.'}, {'measure': 'Plasma anti-CZP antibody titers at Week 52', 'timeFrame': 'Week 52', 'description': 'Blood samples will be collected for measurement of anti-CZP antibody titers at Week 52.'}], 'secondaryOutcomes': [{'measure': 'Incidence of serious treatment emergent adverse events', 'timeFrame': "From Baseline until participant reaches 18 years of age or Cimzia becomes commercially available for pediatric PSO in participant's region (up to 12 years)", 'description': 'A serious treatment emergent adverse event (serious TEAE) is any untoward medical occurrence that at any dose:\n\n* Results in death\n* Is life-threatening\n* Requires in patient hospitalization or prolongation of existing hospitalization\n* Is a congenital anomaly or birth defect\n* Is an infection that requires treatment parenteral antibiotics\n* Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above'}, {'measure': 'Incidence of treatment emergent adverse events leading to withdrawal', 'timeFrame': "From Baseline until participant reaches 18 years of age or Cimzia becomes commercially available for pediatric PSO in participant's region (up to 12 years)", 'description': 'An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participants administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment emergent adverse events (TEAEs) are events that emerge during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic plaque psoriasis', 'Certolizumab pegol', 'Cimzia', 'Pediatric study', 'Phase 3'], 'conditions': ['Moderate Chronic Plaque Psoriasis', 'Severe Chronic Plaque Psoriasis', 'Mixed Guttate/Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the pharmacokinetic (PK) of certolizumab pegol (CZP) in study participants aged 6 to 17 years with moderate to severe chronic plaque psoriasis (PSO) in order to support extrapolation of efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Study participant must have a diagnosis of moderate to severe plaque psoriasis (PSO) for ≥3 months and:\n\n 1. Body Surface Area (BSA) affected by psoriasis ≥10 %\n 2. Physician\'s Global Assessment (PGA) score ≥3 (on a scale from 0 to 4)\n 3. Psoriasis Area and Severity Index (PASI) score is ≥12 or\n 4. PASI score is ≥10 and \\<12 with at least one of the following:\n* \\>Clinically relevant facial or scalp involvement\n* \\>Clinically relevant genital involvement\n* \\>Clinically relevant palm and sole involvement\n* \\>Clinically relevant axillary involvement Study participants aged ≥12 years may alternatively have a diagnosis of moderate to severe mixed guttate/plaque PSO with \\>50 % to \\<80 % guttate lesions for ≥3 months, and must meet the same criteria listed above\n* Study participant must be a candidate for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy\n\nExclusion Criteria:\n\n* Study participant previously participated in this study or has previously been treated with certolizumab pegol (CZP)\n* Study participant has generalized pustular or erythrodermic psoriasis (PSO)\n* Study participant has guttate PSO without plaque PSO\n* Study participant has had a primary failure to an anti-tumor necrosis factor agent\n* Study participant has had prior exposure to \\>2 biologic therapies\n* Study participant has a history of severe major depression or suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Screening/Baseline" version of the Columbia Suicide Severity Rating Scale (CSSRS) at Screening'}, 'identificationModule': {'nctId': 'NCT04123795', 'acronym': 'CIMcare', 'briefTitle': 'A Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Children With Moderate to Severe Chronic Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'Multicenter, Open Label or Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Pediatric Study Participants With Moderate to Severe Chronic Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'PS0007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A - certolizumab pegol', 'description': 'Enrolling study participants aged 12 to 17 years (inclusive). Study participants in this arm will receive weight-based subcutaneous doses of certolizumab pegol from Week 1 to Week 52 of the Active Treatment period and through the subsequent Open-Label Extension Period.', 'interventionNames': ['Drug: Certolizumab pegol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort A - placebo', 'description': 'Enrolling study participants aged 12 to 17 years (inclusive) under Amendment 4 and earlier. Study participants in this arm will receive weight-based subcutaneous doses of placebo from Week 1 to Week 16 of the Active Treatment period.', 'interventionNames': ['Drug: Certolizumab pegol', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B - certolizumab pegol - Open-label', 'description': 'Enrolling study participants aged 6 to 17 years (inclusive). Study participants in this arm will receive weight-based subcutaneous doses of certolizumab pegol from Week 1 to Week 52 of the Open-label Period and through the subsequent Open-Label Extension Period.', 'interventionNames': ['Drug: Certolizumab pegol']}], 'interventions': [{'name': 'Certolizumab pegol', 'type': 'DRUG', 'otherNames': ['-Cimzia', '-CDP870', '-CZP'], 'description': 'Certolizumab Pegol\n\n* Pharmaceutical Form: Solution for injection in pre-filled syringe\n* Route of Administration: Subcutaneous use', 'armGroupLabels': ['Cohort A - certolizumab pegol', 'Cohort A - placebo', 'Cohort B - certolizumab pegol - Open-label']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo\n\n* Pharmaceutical Form: Solution for injection in pre-filled syringe\n* Route of Administration: Subcutaneous use', 'armGroupLabels': ['Cohort A - placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36832', 'city': 'Auburn', 'state': 'Alabama', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ps0007 50214', 'geoPoint': {'lat': 32.60986, 'lon': -85.48078}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Ps0007 50175', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92804', 'city': 'Anaheim', 'state': 'California', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ps0007 50213', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ps0007 50162', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ps0007 50161', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91320', 'city': 'Thousand Oaks', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ps0007 50196', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ps0007 50312', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33428', 'city': 'Boca Raton', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ps0007 50217', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ps0007 50248', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ps0007 50169', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32277', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ps0007 50318', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ps0007 50268', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33186', 'city': 'Miami', 'state': 'Florida', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ps0007 50216', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33024', 'city': 'Pembroke Pines', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ps0007 50246', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '33028', 'city': 'Pembroke Pines', 'state': 'Florida', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ps0007 50184', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '33449', 'city': 'Wellington', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Ps0007 50269', 'geoPoint': {'lat': 26.65868, 'lon': -80.24144}}, {'zip': '30161', 'city': 'Rome', 'state': 'Georgia', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Ps0007 50230', 'geoPoint': {'lat': 34.25704, 'lon': -85.16467}}, {'zip': '31419', 'city': 'Savannah', 'state': 'Georgia', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ps0007 50274', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ps0007 50168', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66210', 'city': 'Overland Park', 'state': 'Kansas', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ps0007 50222', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '66614', 'city': 'Topeka', 'state': 'Kansas', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Ps0007 50286', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '70005', 'city': 'Metairie', 'state': 'Louisiana', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ps0007 50188', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '02135', 'city': 'Brighton', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ps0007 50158', 'geoPoint': {'lat': 42.3501, 'lon': -71.15644}}, {'zip': '48346', 'city': 'Clarkston', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ps0007 50178', 'geoPoint': {'lat': 42.73586, 'lon': -83.41883}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ps0007 50232', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49085', 'city': 'Saint Joseph', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ps0007 50186', 'geoPoint': {'lat': 42.10976, 'lon': -86.48002}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ps0007 50105', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ps0007 50185', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '03801', 'city': 'Portsmouth', 'state': 'New Hampshire', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ps0007 50159', 'geoPoint': {'lat': 43.07704, 'lon': -70.75766}}, {'zip': '11375', 'city': 'Forest Hills', 'state': 'New York', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ps0007 50160', 'geoPoint': {'lat': 40.71621, 'lon': -73.85014}}, {'zip': '10468', 'city': 'The Bronx', 'state': 'New York', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ps0007 50247', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27804', 'city': 'Rocky Mount', 'state': 'North Carolina', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ps0007 50229', 'geoPoint': {'lat': 35.93821, 'lon': -77.79053}}, {'zip': '43302', 'city': 'Marion', 'state': 'Ohio', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ps0007 50326', 'geoPoint': {'lat': 40.58867, 'lon': -83.12852}}, {'zip': '74135', 'city': 'Tulsa', 'state': 'Oklahoma', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ps0007 50212', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '19103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ps0007 50150', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ps0007 50157', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '76011', 'city': 'Arlington', 'state': 'Texas', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Ps0007 50156', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ps0007 50226', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78041', 'city': 'Laredo', 'state': 'Texas', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ps0007 50281', 'geoPoint': {'lat': 27.50641, 'lon': -99.50754}}, {'zip': '78218', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ps0007 50277', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ps0007 50227', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Calgary', 'status': 'WITHDRAWN', 'country': 'Canada', 'facility': 'Ps0007 50163', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Calgary', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Ps0007 50183', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Calgary', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'Ps0007 50225', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Edmonton', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Ps0007 50187', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Montreal', 'status': 'WITHDRAWN', 'country': 'Canada', 'facility': 'Ps0007 50167', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': "St. John's", 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Ps0007 50215', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'city': 'Vancouver', 'status': 'WITHDRAWN', 'country': 'Canada', 'facility': 'Ps0007 50279', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Carolina', 'status': 'RECRUITING', 'country': 'Puerto Rico', 'facility': 'Ps0007 50231', 'geoPoint': {'lat': 18.38078, 'lon': -65.95739}}, {'city': 'Ponce', 'status': 'WITHDRAWN', 'country': 'Puerto Rico', 'facility': 'Ps0007 50278', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}, {'city': 'San Juan', 'status': 'RECRUITING', 'country': 'Puerto Rico', 'facility': 'Ps0007 50265', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'centralContacts': [{'name': 'UCB Cares', 'role': 'CONTACT', 'email': 'UCBCares@ucb.com', 'phone': '0018445992273'}], 'overallOfficials': [{'name': 'UCB Cares', 'role': 'STUDY_DIRECTOR', 'affiliation': '001 844 599 2273 (UCB)'}]}, 'ipdSharingStatementModule': {'url': 'http://www.Vivli.org', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.', 'ipdSharing': 'YES', 'description': 'Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.', 'accessCriteria': 'Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Biopharma SRL', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}