Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
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Study Contact Kontakt: Phone: 844-434-4210 E-Mail: Participate-In-This-Study@its.jnj.com» Kontaktdaten anzeigen
Studienlocations (3 von 111)
NeuroCure Clinical Research Center 10117 Berlin (Berlin) GermanyRekrutierend» Google-MapsUniversitatsmedizin Gottingen 37075 Göttingen (Niedersachsen) GermanyRekrutierend» Google-MapsUniversitaetsklinikum Leipzig 04103 Leipzig (Sachsen) GermanyAbgeschlossen» Google-Maps
Universitatsklinikum Schleswig Holstein Campus Lubeck 23538 Lübeck (Schleswig-Holstein) GermanyAbgeschlossen» Google-MapsUniversitatsklinikum Ulm 89081 Ulm (Baden-Württemberg) GermanyRekrutierend» Google-MapsDKD HELIOS Klinik Wiesbaden, Fachbereich Neurologie 65191 Wiesbaden (Hessen) GermanyAbgeschlossen» Google-MapsNeuromuscular Research Center and Clinic 85028 Paradise Valley United StatesRekrutierend» Google-MapsHonorHealth Neurology 85251 Scottsdale United StatesAbgeschlossen» Google-MapsUniversity of Southern California 90033 Los Angeles United StatesRekrutierend» Google-MapsStanford University 94304 Palo Alto United StatesAbgeschlossen» Google-MapsCare Access Research 91101 Pasadena United StatesRekrutierend» Google-MapsUniversity of Colorado Anschutz Medical Campus 80045 Aurora United StatesRekrutierend» Google-MapsYale New Haven Hospital 06519 New Haven United StatesRekrutierend» Google-MapsFM Clinical Research, LLC South Florida Neurology Associates, P. A. 33487 Boca Raton United StatesRekrutierend» Google-MapsUniversity of Florida Health Jacksonville 32209 Jacksonville United StatesAbgeschlossen» Google-MapsMedsol Clinical Research Center Inc 33952 Port Charlotte United StatesRekrutierend» Google-MapsUniversity of South Florida 33612 Tampa United StatesRekrutierend» Google-MapsAugusta University 30912-3125 Augusta United StatesRekrutierend» Google-MapsUniversity of Kansas Medical Center 66160 Kansas City United StatesRekrutierend» Google-MapsSt. Elizabeth Medical Center 02135 Boston United StatesRekrutierend» Google-MapsLahey Hospital & Medical Center 01805 Burlington United StatesAbgeschlossen» Google-MapsWashington University School of Medicine 63110 Saint Louis United StatesAbgeschlossen» Google-MapsDuke University School of Medicine 27710 Durham United StatesRekrutierend» Google-MapsUniversity of Cincinnati 45219 Cincinnati United StatesAbgeschlossen» Google-MapsCleveland Clinic 44145 Cleveland United StatesRekrutierend» Google-MapsThe Ohio State University 43210 Columbus United StatesRekrutierend» Google-MapsMedical University of South Carolina 29425 Charleston United StatesRekrutierend» Google-MapsWesley Neurology 38018 Cordova United StatesRekrutierend» Google-MapsUT Southwestern Medical Center 75390 Dallas United StatesAbgeschlossen» Google-MapsUniversity of Vermont 05401 Burlington United StatesAbgeschlossen» Google-MapsMelbourne Neurology Group 3051 North Melbourne AustraliaAbgeschlossen» Google-MapsGold Coast University Hospital 4215 Southport AustraliaRekrutierend» Google-MapsULB Hôpital Erasme 1070 Anderlecht BelgiumRekrutierend» Google-MapsAZ Sint-Jan Brugge-Oostende AV 8000 Brugge BelgiumRekrutierend» Google-MapsCliniques Universitaires Saint Luc 1200 Brussels BelgiumRekrutierend» Google-MapsAZ Sint-Lucas 9000 Gent BelgiumRekrutierend» Google-MapsUniversity Hospitals Leuven 3000 Leuven BelgiumRekrutierend» Google-MapsThe Ottawa Hospital Research Institute K1Y 4E9 Ottawa CanadaRekrutierend» Google-MapsToronto General Hospital M5G 2C4 Toronto CanadaRekrutierend» Google-MapsMcGill University H3A 2B4 Montreal CanadaRekrutierend» Google-MapsBeijing Tiantan Hospital, Capital Medical University 100050 Beijing ChinaRekrutierend» Google-MapsXuanwu Hospital ,Capital Medical University 100053 Beijing ChinaRekrutierend» Google-MapsBeijing Hospital 100730 Beijing ChinaRekrutierend» Google-MapsThe First Bethune Hospital of Jilin University 130021 Changchun ChinaRekrutierend» Google-MapsCentral South University Xiangya Hospital The First Affiliated Hospital of Hunan Medical College 410008 Changsha ChinaRekrutierend» Google-MapsWest China Hospital of Sichuan University 610041 Chengdu ChinaRekrutierend» Google-MapsFujian Medical University Union Hospital 350001 Fuzhou ChinaRekrutierend» Google-MapsThe First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine 510405 Guangzhou ChinaRekrutierend» Google-MapsSir Run Run Shaw Hospital, Zhejiang University School of Medicine 310020 Hangzhou ChinaRekrutierend» Google-MapsQianfoshan hospital of Shandong Province 250014 Jinan ChinaRekrutierend» Google-MapsQilu Hospital of Shandong University 250014 Jinan ChinaRekrutierend» Google-MapsHuashan Hospital Fudan University 200040 Shanghai ChinaRekrutierend» Google-MapsTianjin Medical University General Hospital 300052 Tianjin ChinaRekrutierend» Google-MapsThe Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital 710038 Xi'An ChinaRekrutierend» Google-MapsNeurologie a rehabilitace Skopalíkova 615 00 Brno CzechiaRekrutierend» Google-MapsFakultni nemocnice Brno 625 00 Brno CzechiaRekrutierend» Google-MapsVseobecna Fakultní Nemocnice 12808 Praha CzechiaRekrutierend» Google-MapsAalborg University Hospital 9000 Aalborg DenmarkRekrutierend» Google-MapsRigshospitalet 2100 København Ø DenmarkRekrutierend» Google-MapsHopital Pierre Wertheimer 69500 Bron FranceRekrutierend» Google-MapsCHU Grenoble 38043 Grenoble FranceRekrutierend» Google-MapsHopital de la Pitie Salpetriere 75013 Paris FranceRekrutierend» Google-MapsHopital PASTEUR 06000 Provence-Alpes-Côte d'Azur FranceRekrutierend» Google-MapsU.O.P.I. di Psichiatria 95100 Catania ItalyRekrutierend» Google-MapsFondazione Istituto G. Giglio 90015 Cefalu ItalyRekrutierend» Google-MapsIstituto Neurologico Carlo Besta 20133 Milano ItalyRekrutierend» Google-MapsAzienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli 80138 Napoli ItalyRekrutierend» Google-MapsIRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione 27100 Pavia ItalyRekrutierend» Google-MapsAzienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza 00189 Roma ItalyRekrutierend» Google-MapsPoliclinico Universitario Agostino Gemelli 168 Roma ItalyRekrutierend» Google-MapsChiba University Hospital 260 8677 Chiba JapanRekrutierend» Google-MapsGeneral Hanamaki Hospital 025-0082 Hanamaki JapanRekrutierend» Google-MapsHiroshima University Hospital 734 8551 Hiroshima shi JapanRekrutierend» Google-MapsTeikyo University Hospital 173 8606 Itabashi Ku JapanRekrutierend» Google-MapsSt Marianna University Hospital 216 8511 Kawasaki Shi JapanRekrutierend» Google-MapsKagawa University Hospital 761-0793 Kita-Gun JapanRekrutierend» Google-MapsKumamoto University Hospital 860-8556 Kumamoto JapanRekrutierend» Google-MapsIwate Medical University Hospital 020-8505 Morioka-shi JapanRekrutierend» Google-MapsNational Hospital Organization Nagoya Medical Center 460-0001 Nagoya-shi JapanRekrutierend» Google-MapsNiigata City General Hospital 950-1197 Niigata JapanRekrutierend» Google-MapsHyogo College of Medicine Hospital 663-8501 Nishinomiya-Shi JapanRekrutierend» Google-MapsSapporo Medical University Hospital 0608556 Sapporo JapanRekrutierend» Google-MapsHokkaido Medical Center 063-0005 Sapporo JapanRekrutierend» Google-MapsNational Hospital Organization Sendai Medical Center 983-8520 Sendai-City JapanRekrutierend» Google-MapsTokushima University Hospital 770-8503 Tokushima JapanRekrutierend» Google-MapsTokyo Medical University Hospital 160-0023 Tokyo JapanRekrutierend» Google-MapsPusan National University Hospital 49241 Busan Korea, Republic ofRekrutierend» Google-MapsKyungpook National University Chilgok Hospital 41404 Daegu Korea, Republic ofRekrutierend» Google-MapsKyungpook National University Hospital 41944 Daegu Korea, Republic ofRekrutierend» Google-MapsSeverance Hospital Yonsei University Health System 120-752 Seoul Korea, Republic ofRekrutierend» Google-MapsiBiomed Research Unit 20010 Aguascalientes MexicoAbgeschlossen» Google-MapsConsultorio Dr. Miguel Cortes 62448 Cuernavaca MexicoRekrutierend» Google-MapsHospital Civil de Guadalajara Fray Antonio Alcalde 44280 Guadalajara MexicoRekrutierend» Google-MapsNeurocentrum Bydgoszcz Sp Z O O 85-796 Bydgoszcz PolandRekrutierend» Google-MapsNZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis' 40-123 Katowice PolandRekrutierend» Google-MapsCentrum Neurologii Klinicznej, Krakowska Akademia Neurologii 31-505 Krakow PolandRekrutierend» Google-MapsPrywatny Gabinet Lekarski 20-093 Lublin PolandRekrutierend» Google-MapsCentrum Medyczne NeuroProtect 01-684 Warsaw PolandRekrutierend» Google-MapsHosp. Gral. Univ. de Alicante 03010 Alicante SpainRekrutierend» Google-MapsHosp. de La Santa Creu I Sant Pau 08025 Barcelona SpainRekrutierend» Google-MapsHosp. Univ. Vall D Hebron 08035 Barcelona SpainRekrutierend» Google-MapsHosp. Clinic de Barcelona 8036 Barcelona SpainRekrutierend» Google-MapsHosp. Univ. de Basurto 48013 Bilbao SpainRekrutierend» Google-MapsHosp. Virgen Macarena 41009 Sevilla SpainRekrutierend» Google-MapsHosp. Virgen Del Rocio 41013 Sevilla SpainRekrutierend» Google-MapsHosp. Univ. I Politecni La Fe 46026 Valencia SpainRekrutierend» Google-MapsKarlstad Central Hospital 651 85 Karlstad SwedenRekrutierend» Google-MapsKarolinska Universitetssjukhuset Solna 171 76 Stockholm SwedenRekrutierend» Google-MapsChina Medical University Hospital 40447 Taichung TaiwanRekrutierend» Google-MapsShin Kong Wu Ho Su Memorial Hospital 111 Taipei TaiwanRekrutierend» Google-MapsTaipei Veterans General Hospital 11217 Taipei TaiwanRekrutierend» Google-Maps
1. Average Change from Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score (Time Frame - Baseline up to Week 24): Average change from baseline in MG-ADL score over Weeks 22, 23 and 24 of the double-blind placebo-controlled phase will be reported. Averaging over multiple time points (Weeks 22, 23 and 24) will be done to get a single measure. The MG-ADL provides a rapid assessment of the participant's MG symptom severity. Eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, eyelid droop) are rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score will be sum of eight function scores and can range from 0 to 24. A higher score indicates greater symptom severity.
Secondary outcome:
1. Average Change in Quantitative Myasthenia Gravis (QMG) Score Over Weeks 22 and 24 of the Double-blind Placebo-controlled Phase (Time Frame - Up to Weeks 22 and 24): Average change in QMG score over Weeks 22 and 24 of the double-blind placebo-controlled phase will be reported. The QMG test is a standardized quantitative strength assessment comprising 13 components. The quantitative results of each strength component are mapped to the following 4-point scale: 0 equals to (=) none, 1 = mild, 2 = moderate and 3 = severe. The total score will be sum of 13 components scores and can range from 0 to 39. A higher score indicates greater weakness.
2. Percentage of Participants whose Average MG-ADL Total Score Over Weeks 22, 23, and 24 is at least a 2-Point Improvement from Baseline of the Double-blind Placebo-controlled Phase (Time Frame - Baseline up to Weeks 22, 23 and 24): Percentage of participants whose average MG-ADL total score over Weeks 22, 23, and 24 is at least a 2-point improvement from baseline of the double-blind placebo-controlled phase will be reported.
3. Percentage of Participants with Improvement in MG-ADL Total Score Greater Than Or Equal to (>=) 2 Points at Week 1 and/or Week 2 of the Double-blind Placebo-controlled Phase (Time Frame - Weeks 1 and 2): Percentage of participants with improvement in MG-ADL total score >= 2 points at Week 1 and/or Week 2 of the double-blind placebo-controlled phase will be reported.
4. Percentage of Participants with Improvement in MG-ADL Total Score >= 2 Points at Week 4 through Week 24 of the Double-blind Placebo-controlled Phase with No More Than 2 Non-consecutive Excursions Allowed Between Weeks 6 through Week 23 (Time Frame - Week 4 up to Week 24): Percentage of participants with improvement in MG-ADL total score >= 2 points at Week 4 through Week 24 of the double-blind placebo-controlled phase with no more than 2 non-consecutive excursions allowed between Weeks 6 through Week 23 (excursion is defined as loss of improvement in MG-ADL score >= 2 points from baseline) will be reported.
5. Percentage of Participants whose Average Improvement in MG-ADL Total Score Over Weeks 22, 23, and 24 of the Double-blind, Placebo-controlled Phase is at Least a 50% Improvement from Baseline (Time Frame - Baseline, Weeks 22, 23 and 24): Percentage of participants whose average improvement in MG-ADL total score over Weeks 22, 23, and 24 of the double-blind, placebo-controlled phase is at least a 50% improvement from baseline will be reported.
6. Percentage of Participants with Adverse Events (AEs) (Time Frame - Up to Week 24 of double-blind placebo-controlled phase and up to extension Week 24 of open-label extension phase (up to Week 48)): An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
7. Percentage of Participants with Serious Adverse Events (SAEs) (Time Frame - Up to Week 24 of double-blind placebo-controlled phase and up to extension Week 24 of open-label extension phase (up to Week 48)): A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
8. Percentage of Participants with Adverse Events of Special Interest (AESIs) (Time Frame - Up to Week 24 of double-blind placebo-controlled phase and up to extension Week 24 of open-label extension phase (up to Week 48)): Percentage of participants with AESIs will be reported. Treatment-emergent AEs associated with the following situations are considered as AESI: 1) severe or medically significant or immediately life-threatening infections requiring intravenous (IV) anti-infective or operative/invasive intervention or requiring hospitalization or prolongation of existing hospitalization; 2) hypoalbuminemia with albumin less than (<) 20 grams per liter (g/L). Treatment-emergent AEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
9. Percentage of Participants with Change in Vital Signs (Time Frame - Up to Week 24 of double-blind placebo-controlled phase and up to extension Week 24 of open-label extension phase (up to Week 48)): Percentage of participants with change in vital signs (temperature, blood pressure and heart rate) will be reported.
10. Percentage of Participants with Change in Clinical Laboratory Values (Time Frame - Up to Week 24 of double-blind placebo-controlled phase and up to extension Week 24 of open-label extension phase (up to Week 48)): Percentage of participants with change in clinical laboratory (serum chemistry, hematology, lipid profiles and urinalysis) values will be reported.
11. Percentage of Participants with Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score (Time Frame - Up to Week 24 of double-blind placebo-controlled phase and up to extension Week 24 of open-label extension phase (up to Week 48)): Percentage of participants with change in C-SSRS scale score will be reported. C-SSRS is semi structured clinician-administered questionnaire designed to solicit the occurrence, severity, and frequency of suicide-related ideation and behaviors. Total score ranges from 1 to 10. Higher scores indicate greater severity.
12. Percentage of Participants with Improvement in QMG Score of >= 3 Points from Baseline at Week 2 through Week 24 of the Double-blind Placebo-controlled Phase with No More than 2 Non-consecutive Excursions Allowed at Weeks 4 through 22 (Time Frame - Week 2 up to Week 24): Percentage of participants with improvement in QMG score of >= 3 points from baseline at Week 2 through Week 24 of the double-blind placebo-controlled phase with no more than 2 non-consecutive excursions allowed at weeks 4 through 22 (excursions defined as loss of improvement in QMG score of >= 3 points from baseline) will be reported.
13. Average Change From Baseline in the Fatigue Items of the Quality of Life in Neurological Disorders Scale (Neuro-QoL Fatigue) Total Score Over Weeks 22 and 24 of Double-blind Placebo-controlled Phase (Time Frame - Baseline up to Weeks 22 and 24): Average change from baseline in the Neuro-QoL Fatigue total score over Weeks 22 and 24 of double-blind placebo-controlled phase will be reported. Neuro-QoL fatigue is a 19-item questionnaire developed and validated for use in common neurological conditions which assesses patient-reported fatigue and associated impact on physical, mental, and social activities during the past 7 days. Each item included in the Neuro-QoL Fatigue questionnaire is graded on a 5-point Likert-type scale (1=Never; 2=Rarely; 3=Sometimes; 4=Often; 5=Always). The total scores are calculated by summing 19 items score and can range from 19-95. Higher score reflects more fatigue.
14. Average Change from Baseline in the Revised Myasthenia Gravis Quality of Life - 15 Scale (MG-Qol15r) Score Over Weeks 22 And 24 of the Double-blind Placebo-controlled Phase (Time Frame - Baseline up to Weeks 22 and 24): Average change from baseline in the MG-QoL15r score over Weeks 22 and 24 of the double-blind placebo-controlled phase will be reported. The MG-QoL15r is a participant-reported outcome instrument that measures MG-specific health-related quality of life. The MG-QoL15r contains 15 items that evaluate patients' experience related to Myasthenia Gravis over the "past few weeks" on a 3-point Likert-type scale (0=Not at all; 1=Somewhat; 2=Very much). The total score of the MG-QoL15r can be calculated by summing 15 items score and can range from 0 to 30. A higher score indicates poorer health related quality of life.
15. Change from Baseline in the Visual Analog Scale (VAS) Score of European Quality of Life (EuroQol) 5-Dimension 5-Level (EQ-5D-5L) Scale Over 24 Weeks of the Double-blind Placebo-controlled Phase (Time Frame - Baseline up to 24 weeks): Change from baseline in the VAS score of EQ-5D-5L scale over 24 weeks of the double-blind placebo-controlled phase will be reported. EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state). Positive change in score indicates improvement.
16. Change from Baseline in the Health Status Index of the EQ-5D-5L Scale Over 24 Weeks of the Double-blind Placebo-controlled Phase (Time Frame - Baseline up to 24 weeks): Change from baseline in health status index of EQ-5D-5L scale over 24 weeks of double-blind placebo-controlled phase will be reported. EQ-5D-5L is standardized instrument for use as measure of health outcome, primarily designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ-VAS. EQ-5D-5L descriptive system comprises following 5 dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of 5 dimensions is divided into 5 levels of perceived problems (1 indicating no problem, 2 indicating slight problems, 3 indicating moderate problems, 4 indicating severe problems, 5 indicating extreme problems). Participant selects an answer for each of 5 dimensions considering response that best matches his or her health "today". The responses to 5 dimensions are used to compute a single score ranging from zero (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of the individual.
17. Serum Nipocalimab Concentrations Over Time (Time Frame - Up to 4 years and 8 months): Serum nipocalimab concentrations over time will be reported.
18. Number of Participants with Antibodies to Nipocalimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs]) (Time Frame - Up to 4 years and 8 months): Number of participants with antibodies to nipocalimab (ADAs and NAbs) will be reported.
19. Percentage of Participants with MG-ADL Score of 0 or 1 Over Time in the Double-blind, Placebo-controlled Phase (Time Frame - Up to Week 24): Percentage of participants with MG-ADL score of 0 or 1 over time in the double-blind, placebo-controlled phase will be reported.
20. Percentage of Participants with MG-ADL Score of 0 or 1 at Any Time During the Double-blind, Placebo-controlled Phase (Time Frame - Up to Week 24): Percentage of participants with MG-ADL score of 0 or 1 at any time during the double-blind, placebo-controlled phase will be reported.
21. Percentage of Participants with MG-ADL Score of 0 or 1 at 50% of Timepoints During the Double-blind, Placebo-controlled Phase (Time Frame - Up to Week 24): Percentage of participants with MG-ADL score of 0 or 1 at 50% of timepoints during the double-blind, placebo-controlled phase will be reported.
22. Percentage of Participants with MG-ADL Score of 0 or 1 at 75% of Timepoints During the Double-blind, Placebo-controlled Phase (Time Frame - Up to Week 24): Percentage of participants with MG-ADL score of 0 or 1 at 75% of timepoints during the double-blind, placebo-controlled phase will be reported.
23. Change in Total Serum Immunoglobulin G (IgG) Concentrations (Time Frame - Up to 4 years and 8 months): Change in total serum IgG concentrations will be reported.
24. Change in Levels of Autoantibodies Associated with Generalized Myasthenia Gravis (gMG) (Time Frame - Up to 4 years and 8 months): Change in levels of autoantibodies associated with gMG will be reported.
25. Change from Baseline in MG-ADL Score as a Function of IgG (Time Frame - Baseline up to 4 years and 8 months): Change from baseline in MG-ADL score as a function of IgG will be reported.
26. Change from Baseline in QMG Score as a Function of IgG (Time Frame - Baseline up to 4 years and 8 months): Change from baseline in QMG score as a function of IgG will be reported.
27. Change From Baseline in MG-ADL Score as a Response to Percent Change in Autoantibody Levels, in Seropositive Participants Treated with Nipocalimab (Time Frame - Baseline up to 4 years and 8 months): Change from baseline in MG-ADL as a response to percent change in autoantibody levels, in seropositive participants (anti-acetylcholine receptor [anti-AChR], anti-muscle-specific kinase [anti-MuSK], anti-lipoprotein-related protein receptor 4 [anti-LRP4]) treated with nipocalimab will be reported.
28. Change From Baseline in QMG Score as a Response to Percent Change in Autoantibody Levels, in Seropositive Participants Treated with Nipocalimab (Time Frame - Baseline up to 4 years and 8 months): Change from baseline in QMG score as a response to percent change in autoantibody levels, in seropositive participants (anti-AChR, anti-MuSK, anti-LRP4) treated with nipocalimab will be reported.
Experimental: Nipocalimab Double-blind Placebo-controlled Phase: Participants will receive nipocalimab intravenous (IV) infusions once every 2 weeks (q2w) up to 24 weeks during double-blind placebo-controlled phase.
Open-label Extension (OLE) Phase: Participants who complete the double-blind placebo-controlled phase will enter the OLE phase and continue to receive nipocalimab q2w IV infusion till study end.
Placebo Comparator: Placebo Double-blind Placebo-controlled Phase: Participants will receive matching placebo of nipocalimab IV infusion q2w up to 24 weeks during double-blind placebo-controlled phase.
