Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT04700267
Status:
TERMINATED
Last Update Posted:
2021-10-21
First Post:
2021-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Effects of GLPG3970 Given as Oral Treatment for 12 Weeks in Adults With Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Study stopped on business grounds', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-14', 'studyFirstSubmitDate': '2021-01-06', 'studyFirstSubmitQcDate': '2021-01-06', 'lastUpdatePostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in biomarkers associated with disease anti-dsDNA', 'timeFrame': 'Between Day 1 and 104', 'description': 'To characterize the PD of GLPG3970 compared to placebo in adult subjects with active SLE'}, {'measure': 'Change in biomarkers associated with disease complement component 3 (C3), and complement component 4 (C4)', 'timeFrame': 'Between Day 1 and 104', 'description': 'To characterize the PD of GLPG3970 compared to placebo in adult subjects with active SLE'}, {'measure': 'Number, incidence, and severity of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'From screening through study completion, an average of 5 months', 'description': 'To evaluate the safety and tolerability of GLPG3970 compared to placebo in adult subjects with active SLE'}], 'secondaryOutcomes': [{'measure': 'Observed GLPG3970 plasma trough concentrations (Ctrough)', 'timeFrame': 'Between Day 1 and 87', 'description': 'To characterize the PK of GLPG3970 in adult subjects with active SLE'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': 'This is a first exploration of GLPG3970 in subjects with active systemic lupus erythematosus (SLE) to evaluate the effect on disease biomarkers and to determine its pharmacokinetics (PK) profile, safety and tolerability, and pharmacodynamics (PD) biomarkers related to the investigational product (IP) mechanism of action and the pathophysiology of SLE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* SLE diagnosis defined by American College of Rheumatology (ACR) 1997 criteria ≥4\n* Active arthritis in \\>=4 active joints (according to 28 joint count) and/or cutaneous lupus erythematosus disease area and severity index (CLASI) score \\>=6.\n* Anti-dsDNA antibodies \\>15 IU/mL.\n* Stable standard-of-care (SoC) therapy (defined as no change in prescription for at least 2 weeks prior to first IP dosing) consisting of the following permitted SoC medications:\n\n * Corticosteroids \\<=20 mg/day (prednisone or equivalent) for at least 2 weeks prior to first IP dosing; AND/OR\n * Non-steroidal anti-inflammatory drug (NSAIDs); AND/OR\n * One single antimalarial at a stable dose (hydroxychloroquine \\<=5 mg/ kg/day, quinacrine 100 mg/day, or chloroquine 2.3 mg/kg/day) for at least 8 weeks prior to first IP dosing; AND/OR\n * One single immunosuppressant at a stable dose (azathioprine (AZA) \\<=2 mg/kg/day, methotrexate (MTX) \\<=20 mg/week, or mycophenolate mofetil (MMF) \\<=2 g/day) for at least 8 weeks prior to first IP dosing.\n* estimated glomerular filtration rate (eGFR) \\>=60 mL/min (according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI))\n\nThis list only contains the key inclusion criteria.\n\nExclusion Criteria:\n\n* Lupus nephritis \\>= Class III\n* Severe organ manifestation or life-threatening lupus disease (active severe central nervous system lupus, severe pleuro-pericarditis, severe vasculitis).\n* Severe acute respiratory syndrome coronavirus disease 2 (SARS-CoV-2) infection \\>0\n* Unstable condition not related to SLE\n* Systemic inflammatory condition other than SLE such as, but not limited to rheumatoid arthritis (RA), spondyloarthropathy, Crohn's disease, ulcerative colitis, or psoriatic arthritis\n* Sjögren's syndrome and/or antiphospholipid antibody syndrome who do not require treatment with any prohibited medication are NOT excluded.\n* Active systemic infection\n* Poorly controlled chronic cardiac, pulmonary, or renal disease.\n* Known or suspected history of or a current immunosuppressive condition, or a history of invasive opportunistic infections\n* Treatment with disallowed therapies\n\nThis list only contains the key exclusion criteria."}, 'identificationModule': {'nctId': 'NCT04700267', 'acronym': 'TAPINOMA', 'briefTitle': 'A Study Evaluating the Effects of GLPG3970 Given as Oral Treatment for 12 Weeks in Adults With Systemic Lupus Erythematosus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galapagos NV'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Orally Administered GLPG3970 for 12 Weeks in Adult Subjects With Active Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': 'GLPG3970-CL-102'}, 'secondaryIdInfos': [{'id': '2020-001820-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GLPG3970', 'description': 'One dose level of GLPG3970', 'interventionNames': ['Drug: GLPG3970 film-coated tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'One dose level of Placebo', 'interventionNames': ['Drug: Placebo film-coated tablet']}], 'interventions': [{'name': 'GLPG3970 film-coated tablet', 'type': 'DRUG', 'description': 'GLPG3970 for oral administration', 'armGroupLabels': ['GLPG3970']}, {'name': 'Placebo film-coated tablet', 'type': 'DRUG', 'description': 'Placebo for oral administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5800', 'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Medical center Medconsult Pleven', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '4002', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'UMHAT-Plovdiv AD', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '1612', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'UMHAT Sv. Ivan Rilski EAD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '2025', 'city': 'Chisinau', 'country': 'Moldova', 'facility': 'ARENSIA Exploratory Medicine Phase I Unit', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'zip': '85168', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Szpital Uniwersytecki nr 2 im.dr J. Biziela', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '30363', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Centrum Medyczne Plejady', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '00874', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Medycyna Kliniczna', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '50088', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'FutureMeds sp. Z o. o.', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '8041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '01135', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Medical Centre of Ltd Liability Comp', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '65026', 'city': 'Odesa', 'country': 'Ukraine', 'facility': 'Multidisciplinary Medical Center of Odesa National Medical University', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'zip': '21028', 'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'N.I.Pirogov Vinnytsia Reg Council', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'zip': '21029', 'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'SRI of Invalid Rehabilitation', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'zip': '69600', 'city': 'Zaporizhzhia', 'country': 'Ukraine', 'facility': 'LLC Suchasna klinika', 'geoPoint': {'lat': 47.15214, 'lon': 35.74246}}], 'overallOfficials': [{'name': 'Catherine Vincent, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galapagos NV'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galapagos NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}