Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT06741969
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2024-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nipocalimab in Moderate to Severe Sjogren's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012859', 'term': "Sjogren's Syndrome"}], 'ancestors': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to one of the 2 identical studies (conducted under this single protocol) to make a total of 300 participants in each study. Participants in each study will be randomly assigned to one of the arms nipocalimab or placebo respectively.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-08-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2024-12-18', 'studyFirstSubmitQcDate': '2024-12-18', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48", 'timeFrame': 'Baseline to Week 48', 'description': 'ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD. The ClinESSDAI includes 11 domains divided into 3-4 activity levels, where zero represents no activity and low, medium, and high scores can vary in numerical value depending on the domain being measured. A higher score represents worse disease symptoms.'}], 'secondaryOutcomes': [{'measure': 'Improvement from Baseline in Minimal Clinically Important Improvement (MCII) in ClinESSDAI Score at Week 48', 'timeFrame': 'Baseline to Week 48', 'description': "The ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with Sjogren's syndrome."}, {'measure': 'Improvement from Baseline in ClinESSDAI Score at Week 48 in Participants with High Immunoglobulin (IgG) Levels at Baseline', 'timeFrame': 'Baseline to Week 48', 'description': 'ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD.'}, {'measure': 'Change from Baseline in ClinESSDAI Score at Week 8', 'timeFrame': 'Baseline to Week 8', 'description': 'ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD.'}, {'measure': 'Change from Baseline in Stimulated Salivary Flow Rate at Week 48', 'timeFrame': 'Baseline to Week 48', 'description': 'Stimulated salivary flow is considered a reliable and objective method to evaluate glandular function in SjD patients.'}, {'measure': "Change from Baseline in Sjogren's Symptoms Dryness Score at Week 48", 'timeFrame': 'Baseline to Week 48', 'description': 'Participants will be asked to report the worst severity of their dryness symptoms on a 0 to 10 numeric rating scale (NRS), with score 0 indicating "No \\[specific symptom\\]" and score 10 indicating "Severe \\[specific symptom\\]". Higher scores reflect greater symptom severity. Change from baseline in Sjogren\'s Symptoms dryness score at Week 48 for US, US reference regions, and other non-US regions will be reported.'}, {'measure': "Change from Baseline in Sjogren's Symptoms Joint Pain Score at Week 48", 'timeFrame': 'Baseline to Week 48', 'description': 'Participants will be asked to report the worst severity of their joint pain symptoms on a 0 to 10 numeric rating scale (NRS), with score 0 indicating "No \\[specific symptom\\]" and score 10 indicating "Severe \\[specific symptom\\]". Higher scores reflect greater symptom severity. Change from baseline in Sjogren\'s Symptoms joint pain score at Week 48 for US, US reference regions, and other non-US regions will be reported.'}, {'measure': "Change from Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) Score At Week 48", 'timeFrame': 'Baseline to Week 48', 'description': 'ESSPRI is a participant-reported assessment of the severity of dryness, fatigue, and pain associated with primary Sjogren\'s Syndrome. Participants are asked to rate the severity of dryness, fatigue, and pain on a 0 to 10 NRS, with score 0 indicating "No \\[specific symptom\\]" and score 10 indicating "Severe \\[specific symptom\\]". A global score, calculated as the mean of the 3 domain scores, ranges from 0 to 10, with higher scores reflecting greater (worse) symptom severity. Change from baseline in Sjogren\'s Symptoms score at Week 48 for EU, UK \\& EU reference regions will be reported.'}, {'measure': 'Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT) Fatigue Score at Week 48', 'timeFrame': 'Baseline to Week 48', 'description': 'FACIT-Fatigue version 4.0 is a 13-item questionnaire that assesses participant-reported fatigue and its impact upon daily activities and function over the past 7 days. Participants will be asked to answer each question using a 5-point Likert scale (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; and 4=Very much). FACIT-Fatigue has a total score range from 0 to 52, with 0 being the worst possible score and 52 the best.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sjogrens Disease'], 'conditions': ['Sjogrens Syndrome']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the clinical efficacy and safety of nipocalimab in participants with moderate to severe Sjogren's disease (SjD).", 'detailedDescription': 'This clinical development program for nipocalimab in SjD includes 2 identical double blind, placebo-controlled studies to evaluate the efficacy, safety, and tolerability of nipocalimab in participants greater than or equal to (\\>=) 18 years of age with moderate to severe SjD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:-\n\n* Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening\n* Meets criteria for diagnosis of SjD by the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria\n* Seropositive for antibodies to Ro/SSA (Ro60 and/or Ro52) at screening\n* Total ClinESSDAI score greater than or equal to (\\>=) 5 at screening\n* Participants of childbearing potential must have a negative highly sensitive serum (beta-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 prior to randomization\n\nExclusion Criteria:\n\n* Has a history of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder or clinically significant abnormalities in screening laboratory\n* Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients or excipients used in the placebo formulation\n* Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her SjD or has a family history of congenital or hereditary immunodeficiency\n* Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins (for example \\[e.g.\\], monoclonal antibodies, intravenous immunoglobulin)\n* Has any unstable or progressive manifestation of SjD that is likely to warrant escalation in therapy beyond permitted background medications'}, 'identificationModule': {'nctId': 'NCT06741969', 'acronym': 'DAFFODIL', 'briefTitle': "Nipocalimab in Moderate to Severe Sjogren's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': "A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 3 Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults With Moderate to Severe Sjogren's Disease (SjD)", 'orgStudyIdInfo': {'id': '80202135SJS3001'}, 'secondaryIdInfos': [{'id': '80202135SJS3001', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2024-513965-38-00', 'type': 'REGISTRY', 'domain': 'EUCT number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nipocalimab', 'description': 'Participants will receive nipocalimab subcutaneously (SC) along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an open-label long-term extension (OLE) phase, where they will continue to receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study.', 'interventionNames': ['Drug: Nipocalimab', 'Drug: Standard of care treatment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo subcutaneously along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an OLE phase, where they will receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study.', 'interventionNames': ['Drug: Placebo', 'Drug: Standard of care treatment']}], 'interventions': [{'name': 'Nipocalimab', 'type': 'DRUG', 'otherNames': ['JNJ-80202135, JNJ-86507083, M281'], 'description': 'Nipocalimab SC.', 'armGroupLabels': ['Nipocalimab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo SC.', 'armGroupLabels': ['Placebo']}, {'name': 'Standard of care treatment', 'type': 'DRUG', 'description': 'Protocol-defined topical and systemic standard of care background treatments.', 'armGroupLabels': ['Nipocalimab', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91910', 'city': 'Chula Vista', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Advanced Clinical Research Center', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Providence Medical Foundation', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90623', 'city': 'La Palma', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Arthritis & Osteoporosis Medical Center - La Palma', 'geoPoint': {'lat': 33.8464, 'lon': -118.04673}}, {'zip': '91754', 'city': 'Monterey Park', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NovaMed Research', 'geoPoint': {'lat': 34.06251, 'lon': -118.12285}}, {'zip': '94578', 'city': 'San Leandro', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Medvin Clinical Research San Leandro', 'geoPoint': {'lat': 37.72493, 'lon': -122.15608}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Providence Saint John s Health Center', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Solace Clinical Research California', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Inland Rheumatology Clinical Trials Inc.', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '80230', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Denver Arthritis Clinic', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Research of West Florida Inc', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UF Health Rheumatology', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Suncoast Clinical Research', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sarasota Arthritis Center', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'BioResearch Partner', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '30024', 'city': 'Suwanee', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Immunology and Rheumatology Research Associates LLC', 'geoPoint': {'lat': 34.05149, 'lon': -84.0713}}, {'zip': '60076', 'city': 'Skokie', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Investigation Specialists - 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Clinical and Translational Science Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Pioneer Clinical Research NY', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Joint and Muscle Research Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28211', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Atrium Health SouthPark Rheumatology', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Onsite Clinical Solutions', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '45324', 'city': 'Fairborn', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Wright State Physicians Health Center', 'geoPoint': {'lat': 39.82089, 'lon': -84.01938}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'OMRF Rheumatology Center of Excellence', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73116', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Rheumatology Associates of Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Altoona Center For Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '19114', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Research Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29486', 'city': 'Summerville', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Low Country Rheumatology PA', 'geoPoint': {'lat': 33.0185, 'lon': -80.17565}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'West Tennessee Research Institute', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '37128', 'city': 'Murfreesboro', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'AARA Clinical Research - 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Swiss Medical Group'}, {'zip': 'C1428', 'city': 'Ciudad de Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Cosultorios Reumatologógicos Pampa'}, {'zip': 'B1878DVB', 'city': 'Quilmes', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Cer Instituto Medico', 'geoPoint': {'lat': -34.72065, 'lon': -58.25454}}, {'zip': 'B1646GHP', 'city': 'San Fernando', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'MR Medicina Reumatologica', 'geoPoint': {'lat': -34.44104, 'lon': -58.56279}}, {'zip': 'T4000AXL', 'city': 'San Miguel de Tucumán', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Centro de Investigaciones Medicas Tucuman', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': '8036', 'city': 'Graz', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Medizinische Universitaet Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '5020', 'city': 'Salzburg', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'SCRI CCCIT gem GmbH', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '2000', 'city': 'Stockerau', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'LK Weinviertel Stockerau', 'geoPoint': {'lat': 48.38333, 'lon': 16.21667}}, {'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Medizinische Universitaet Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1130', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Wiener Gesundheitsverbund Klinik Hietzing', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '70390 700', 'city': 'Brasília', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': 'Instituto D Or de Pesquisa e Ensino', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}, {'zip': '80030 110', 'city': 'Curitiba', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': 'Ceti - Centro de Estudos Em Terapias Inovadoras', 'geoPoint': {'lat': -25.42778, 'lon': 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