Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-30 @ 10:13 PM
Study NCT ID:
NCT06956235
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}], 'ancestors': [{'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 147}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-01-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-04-30', 'studyFirstSubmitQcDate': '2025-04-30', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 50 at Week 16', 'timeFrame': 'Week 16', 'description': 'The percentage of participants with ≥50% reduction in total abscesses and inflammatory nodules (AN) count with no increase in abscess count, and no increase in draining tunnels (ie, HiSCR50) will be reported.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving HiSCR75 at Week 16', 'timeFrame': 'Week 16', 'description': 'The percentage of participants with ≥75% reduction in total abscesses and inflammatory nodules (AN) count with no increase in abscess count, and no increase in draining tunnels (ie, HiSCR75) will be reported.'}, {'measure': 'Mean Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16', 'timeFrame': 'Week 16', 'description': 'The DLQI is a validated dermatology-specific instrument that measures the HRQoL in adult patients with skin diseases. The DLQI consists of 10 questions and provides a total HRQoL score, as well as scores for 6 aspects of QoL: symptoms and feelings; daily activities; leisure; work/school; personal relationships; and treatment. The recall period is over the last week. Question responses are assessed using a 4-point Likert rating scale ranging from "not at all" (scored 0) to "very much" (scored 3). The final score ranges from 0 (no impact on QOL) to 30 (maximum impairment). The mean change from baseline in DLQI at Week 16 will be reported.'}, {'measure': 'Percentage of Participants Who Experience One or More Adverse Events (AEs)', 'timeFrame': 'Up to ~130 weeks', 'description': 'An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants with any AE will be reported.'}, {'measure': 'Percentage of Participants Who Discontinue Study Intervention Due to an AE', 'timeFrame': 'Up to ~116 weeks', 'description': 'An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants discontinuing from study intervention due to AE will be reported.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hidradenitis Suppurativa']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'This is a phase 2b randomized, double-blind, placebo-controlled study of the safety and efficacy of tulisokibart in participants with moderate to severe hidradenitis suppurativa. The primary hypothesis is that at least 1 dose of tulisokibart is superior to placebo with respect to the proportion of participants achieving a 50% reduction in Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16 (ie, at end of double-blind treatment).', 'detailedDescription': 'This study consists of a 16-week Double-blind Period and a 100-week Long-term Extension (LTE) composed of a 40-week Main Extension and a 60-week Optional Extension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has signs and symptoms of hidradenitis suppurativa (HS) for ≥6 months prior to Screening and a clinical diagnosis of HS at Screening\n* Has moderate or severe HS defined as a total combined number of ≥ 5 abscesses and/or inflammatory nodules, with HS lesions present in ≥ 2 distinct anatomical areas and ≥ 1 anatomic area of HS involvement characterized as Hurley Stage II or III\n* Has a history of inadequate response to a course of systemic antibiotics for treatment of HS or intolerance to or has a contraindication to systemic antibiotics for treatment of HS\n* Has ≤20 draining tunnel count at Screening and Randomization\n\nExclusion Criteria:\n\n* Has other active skin conditions that may, in the judgment of the investigator, interfere with the assessment of HS\n* Has any immune-mediated inflammatory condition that is not well controlled and which may potentially require biologic therapy\n* Has a transplanted organ and requires continued systemic immunosuppression\n* Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\<5 years\n* Has had a diagnostic evaluation suggestive of malignancy (eg, chest or breast imaging) and the possibility of malignancy cannot be reasonably excluded following additional clinical assessments\n* Has a known infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)\n* Has any active infection\n* Has active tuberculosis\n* Has had major surgery within the past 3 months or has a major surgery planned during the study\n* Has a history of clinically significant drug or alcohol abuse within the past 6 months\n* Has prior exposure to tulisokibart\n* Has undergone laser therapy or surgical procedures for their lesions within the past 6 weeks or is planning to have laser therapy or surgical procedures for lesions during participation in the study\n* Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients'}, 'identificationModule': {'nctId': 'NCT06956235', 'briefTitle': 'Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderate to Severe Hidradenitis Suppurativa', 'orgStudyIdInfo': {'id': '7240-012'}, 'secondaryIdInfos': [{'id': 'U1111-1316-5263', 'type': 'REGISTRY', 'domain': 'UTN'}, {'id': '2024-520039-33-00', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': 'jRCT2011250007', 'type': 'REGISTRY', 'domain': 'Japan Registry of Clinical Trials (jRCT)'}, {'id': 'MK-7240-012', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: High Dose', 'description': 'Participants receive a high dose tulisokibart regimen.', 'interventionNames': ['Drug: Tulisokibart']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Medium Dose', 'description': 'Participants receive a medium dose tulisokibart regimen.', 'interventionNames': ['Drug: Tulisokibart']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: Low Dose', 'description': 'Participants receive a low dose tulisokibart regimen.', 'interventionNames': ['Drug: Tulisokibart']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 4: Placebo', 'description': 'Participants receive a placebo regimen, and are then allocated to a medium or high tulisokibart dose regimen after Week 16.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tulisokibart', 'type': 'DRUG', 'otherNames': ['PRA023', 'MK-7240'], 'description': 'Solution in autoinjector for subcutaneous (SC) injection', 'armGroupLabels': ['Arm 1: High Dose', 'Arm 2: Medium Dose', 'Arm 3: Low Dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Solution in autoinjector for SC injection', 'armGroupLabels': ['Arm 4: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35244', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cahaba Dermatology & Skin Health Center ( Site 0012)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Medical Dermatology Specialists ( Site 0027)', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Northwest Arkansas Clinical Trials Center, PLLC ( Site 0049)', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Northridge Clinical Trials ( Site 0004)', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Integrative Skin Science and Research ( Site 0015)', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '33615', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Olympian Clinical Research ( Site 0010)', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '31217', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Skin Care Physicians of Georgia ( Site 0033)', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Dawes Fretzin Clinical Research Group, LLC ( Site 0025)', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center ( Site 0044)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48084', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Revival Research Institute, LLC ( Site 0005)', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '10028', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Doctors - East 85th Street ( Site 0050)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28211', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'DJL Clinical Research, PLLC ( Site 0021)', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center ( Site 0046)', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '45324', 'city': 'Fairborn', 'state': 'Ohio', 'country': 'United States', 'facility': 'Wright State Physicians Health Center ( Site 0041)', 'geoPoint': {'lat': 39.82089, 'lon': -84.01938}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Palmetto Clinical Trial Services, LLC ( Site 0023)', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '76011', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Arlington Center for Dermatology ( Site 0045)', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Dermatology Research Center ( Site 0019)', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75033', 'city': 'Frisco', 'state': 'Texas', 'country': 'United States', 'facility': 'Reveal Research Institute ( Site 0018)', 'geoPoint': {'lat': 33.15067, 'lon': -96.82361}}, {'zip': '78213', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Progressive Clinical Research ( Site 0020)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': 'C1061AAT', 'city': 'CABA', 'country': 'Argentina', 'facility': 'CIPREC ( Site 0202)'}, {'zip': 'C1199ABB', 'city': 'CABA', 'country': 'Argentina', 'facility': 'Hospital Italiano de Buenos Aires ( Site 0205)'}, {'zip': 'C1425DKG', 'city': 'CABA', 'country': 'Argentina', 'facility': 'Psoriahue ( Site 0203)'}, {'zip': 'C1426EGR', 'city': 'CABA', 'country': 'Argentina', 'facility': 'Derma Internacional SA ( Site 0206)'}, {'zip': '1871', 'city': 'Liverpool', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Liverpool Hospital ( Site 1403)', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital ( Site 1401)', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6160', 'city': 'Fremantle', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Fremantle Dermatology ( Site 1402)', 'geoPoint': {'lat': -32.05632, 'lon': 115.74557}}, {'zip': 'R3M 3Z4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Wiseman Dermatology Research Inc. ( Site 0107)', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'E3B 1G9', 'city': 'Frederiction', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Brunswick Dermatology Center ( Site 0101)'}, {'zip': 'L3P 1X3', 'city': 'Markham', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Lynderm Research Inc. ( Site 0104)', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}, {'zip': 'K9J 5K2', 'city': 'Peterborough', 'state': 'Ontario', 'country': 'Canada', 'facility': 'SKiN Centre for Dermatology ( Site 0103)', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}, {'zip': 'L4B 1L1', 'city': 'Richmond Hill', 'state': 'Ontario', 'country': 'Canada', 'facility': 'York Dermatology Clinic & Research Centre ( Site 0106)', 'geoPoint': {'lat': 43.87111, 'lon': -79.43725}}, {'zip': '7580206', 'city': 'Santiago', 'state': 'Region M. de Santiago', 'country': 'Chile', 'facility': 'Centro Skin Med Limitada ( Site 0305)', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '7640881', 'city': 'Santiago', 'state': 'Region M. de Santiago', 'country': 'Chile', 'facility': 'Clinica Dermacross ( Site 0301)', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '8420383', 'city': 'Santiago', 'state': 'Region M. de Santiago', 'country': 'Chile', 'facility': 'Centro Internacional de Estudios Clinicos (CIEC) ( Site 0302)', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '516006', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Dermatology Hospital of Southern Medical University ( Site 1504)', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '410011', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'The Second Xiangya Hospital of Central South University ( Site 1505)', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'The First Hospital of Jilin University ( Site 1502)', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital Shanghai Jiaotong University School of Medicine ( Site 1515)', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Huashan Hospital of Fudan University ( Site 1506)', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '830001', 'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': "PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 1509)", 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 1501)', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '050021', 'city': 'Medellín', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'Servicios de Salud IPS Suramericana S.A.S. - IPS Sura San Diego ( Site 0404)', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'zip': '760032', 'city': 'Cali', 'state': 'Valle del Cauca Department', 'country': 'Colombia', 'facility': 'Fundación Valle del Lili ( Site 0403)', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'zip': '69003', 'city': 'Lyon', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Hôpital Edouard Herriot ( Site 0601)', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '33000', 'city': 'Bordeaux', 'state': 'Gironde', 'country': 'France', 'facility': 'CHU de Bordeaux Hop St ANDRE ( Site 0603)', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '83800 Cede', 'city': 'Toulon', 'state': 'Var', 'country': 'France', 'facility': 'HIA Sainte Anne ( Site 0606)', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '75679', 'city': 'Paris', 'country': 'France', 'facility': 'Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0602)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Frankfurt Universitaetsklinikum EC ( Site 0706)', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite - Universtitatsmedizin Berlin CCM ( Site 0708)', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '60126', 'city': 'Ancona', 'state': 'The Marches', 'country': 'Italy', 'facility': 'AOU Ospedali Riuniti di Ancona ( Site 1805)', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico ( Site 1806)", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1801)', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '467-8602', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Nagoya City University Hospital ( Site 1603)', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '060-0063', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Medical Corporation Kojinkai Sapporo Skin Clinic ( Site 1606)', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '901-2725', 'city': 'Ginowan', 'state': 'Okinawa', 'country': 'Japan', 'facility': 'University of the Ryukyus Hospital ( Site 1601)', 'geoPoint': {'lat': 26.26265, 'lon': 127.76147}}, {'zip': '173-8610', 'city': 'tabashi City', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Nihon University Itabashi Hospital ( Site 1602)', 'geoPoint': {'lat': 35.74893, 'lon': 139.71497}}, {'zip': '814-0180', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Fukuoka University Hospital ( Site 1604)', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '602-8566', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'University Hospital,Kyoto Prefectural University of Medicine ( Site 1605)', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '4818 CK', 'city': 'Breda', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Amphia Ziekenhuis, locatie Breda Molengracht ( Site 0902)', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'zip': '3015 GD', 'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Erasmus Medisch Centrum ( Site 0901)', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '117599', 'city': 'Singapore', 'state': 'Central Singapore', 'country': 'Singapore', 'facility': 'National Universtity Hospital IMU ( Site 0802)', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '308205', 'city': 'Singapore', 'state': 'Central Singapore', 'country': 'Singapore', 'facility': 'National Skin Centre ( Site 0801)', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '46940', 'city': 'Manises', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital de Manises ( Site 1103)', 'geoPoint': {'lat': 39.49139, 'lon': -0.46349}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron ( Site 1102)", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari de Bellvitge ( Site 1101)', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '18012', 'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Nieves ( Site 1104)', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': 'DY1 2HQ', 'city': 'Dudley', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Russells Hall Hospital ( Site 1303)', 'geoPoint': {'lat': 52.5, 'lon': -2.08333}}, {'zip': 'E1 1BB', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal London Hospital ( Site 1301)', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://externaldatasharing-msd.com/', 'ipdSharing': 'YES', 'description': 'https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}