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| ID | Type | Description | Link |
|---|---|---|---|
| MOM-M281-011 | Other Identifier | Janssen Research & Development, LLC | |
| 2020-005732-29 | EudraCT Number | ||
| 2023-504152-97-00 | Registry Identifier | EUCT number |
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The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG). The purpose of the subcutaneous substudy is to evaluate how well it works in the body (pharmacodynamic [PD]) when given as an injection under the skin (subcutaneous) compared to when given through a vein (intravenous) in participants with gMG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nipocalimab | Experimental | 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 will have the option to continue to receive nipocalimab q2w IV infusion till study end or enter the nipocalimab SC substudy. |
|
| Placebo | Placebo Comparator | 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. |
|
| Nipocalimab Subcutaneous (SC) | Experimental | OLE Phase: Participants from Cohort 1 will receive nipocalimab subcutaneous liquid in vial (SC-LIV) qw until Week 8. Participants with gMG from Cohort 2 who have not received nipocalimab previously, will receive nipocalimab SC-LIV until Week 8. Participants who complete the 8-week treatment period will have the opportunity to continue receiving nipocalimab SC-LIV qw in the Long term extension (LTE) period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nipocalimab | Drug | Nipocalimab will be administered as an IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Double-blind (DB) Phase: Average Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24 | Average change from baseline over multiple timepoints (Weeks 22, 23, and 24) was reported in this outcome measure. The MG-ADL provided a rapid assessment of the participant's MG symptom severity of 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) rated on a 4-point scale ranging from 0 (normal) to 3 (severe). MG-ADL total score was sum of 8 individual items, which ranging from 0 to 24. A higher score indicated greater symptom severity. Baseline was defined as the average of the screening and Day 1 total scores. | Baseline, Weeks 22, 23, and 24 |
| Sub Study: Percent Change in Anti-AChR Autoantibody Titer From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57) | From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57) | |
| Sub Study: Percent Change in Total IgG Levels From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57) | From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57) |
| Measure | Description | Time Frame |
|---|---|---|
| DB Phase: Average Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score Over Weeks 22 and 24 | Baseline, Weeks 22, and 24 | |
| DB Phase: Percentage of Participants Who Had Achieved at Least a 2-point Average Improvement From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuromuscular Research Center and Clinic | Recruiting | Paradise Valley | Arizona | 85028 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42084498 | Derived | Yu F, Myshkin E, Nguyen B, Bobadilla Mendez C, Cossu M, Fei K, Wang Q, Hubbard JJ, Campbell K, Ramchandren S, Rojo Cella R, Edwards R, Taylor PC, Gottenberg JE, Noaiseh G, Vu T, Antozzi C, Winthrop KL, Cuff CA, Loza MJ, Dimitrova D, Gao S. Effect of nipocalimab on IgG responses to vaccinations and viral infections in patients with IgG autoantibody-mediated diseases: Post hoc analyses of three randomized, placebo-controlled trials. Hum Vaccin Immunother. 2026 Dec;22(1):2664331. doi: 10.1080/21645515.2026.2664331. Epub 2026 May 5. | |
| 41021216 |
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The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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As per protocol amendment 4, sub-study was added for which recruitment is currently ongoing. The current result are reported up to the (PCD, 17-Nov-2023) of double blind phase. For open-label extension (OLE) phase, data for participants that were enrolled in OLE phase until the PCD is presented. OLE phase is still ongoing and complete results will be posted upon study completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Double Blind (DB) Phase: Placebo | During double blind (DB) phase, participants of present study received placebo matching to nipocalimab intravenous (IV) infusion as a loading dose on Day 1 (Week 0) followed by placebo matching to nipocalimab IV infusion as maintenance dose once every 2 weeks (q2w) from Week 2 up to Week 24. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| DB Phase: Day 1 (Week 0) to Week 24 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 15, 2024 | May 27, 2025 |
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| Placebo | Drug | Matching placebo will be administered as an IV infusion. |
|
| Nipocalimab SC-LIV | Drug | Nipocalimab will be administered subcutaneously. |
|
| Weeks 22, 23, and 24 |
| DB Phase: Percentage of Participants Who Had Achieved an Improvement of Greater Than or Equal to (>=) 2 Points in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score at Week 1 and/or Week 2 | Weeks 1 and 2 |
| DB Phase: Percentage of Participants Who Had an Improvement of >= 2 Points in the MG-ADL Total Score From Week 4 Through Week 24 With no More Than 2 Non-consecutive Excursions Allowed Between Weeks 6 Through 23 | From Week 4 up to Week 24 |
| DB Phase: Percentage of Participants Who Had Achieved at Least a 50 Percent (%) Average Improvement From Baseline in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24 | Weeks 22, 23, and 24 |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | From start of treatment (DB phase Day 1) up to 4 years 9 months |
| Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | From start of treatment (DB phase Day 1) up to 4 years 9 months |
| Percentage of Participants With AEs of Special Interest (AESIs) | From start of treatment (DB phase Day 1) up to 4 years 9 months |
| Number of Participants With Change in Vital Signs | From start of treatment (DB phase Day 1) up to 4 years 9 months |
| Number of Participants With Change in Clinical Laboratory Values | From start of treatment (DB phase Day 1) up to 4 years 9 months |
| Number of Participants With Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score | From start of treatment (Day 1) up to 4 years 9 months |
| DB Phase: Percentage of Participants Who Had an Improvement of >= 3 Points in Quantitative Myasthenia Gravis (QMG) Score From Baseline, at Week 2 Through Week 24, With No More Than 2 Non-consecutive Excursions Allowed Between at Weeks 4 Through Week 22 | Baseline, Week 2 up to Week 24 |
| DB Phase: Average Change From Baseline in the Fatigue Items of the Quality of Life in Neurological Disorders (Neuro-QoL) Fatigue Scale Total Score Over Weeks 22 and 24 | Baseline up to Weeks 22, and 24 |
| DB Phase: Average Change From Baseline in the Revised Myasthenia Gravis Quality of Life (Revised) Instrument (MG-Qol15r) Score Over Weeks 22 And 24 | Baseline up to Weeks 22, and 24 |
| DB Phase: 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 | Baseline up to Week 24 |
| DB Phase: Change From Baseline in the Health Status Index of the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scale Over 24 Weeks | Baseline up to Week 24 |
| DB Phase: Percentage of Participants With Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score of 0 or 1 Over Time | Baseline up to Week 24 |
| DB Phase: Percentage of Participants With Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score of 0 or 1 at Any Time | Baseline up to Week 24 |
| DB Phase: Percentage of Participants With Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score of 0 or 1 at 50% of Timepoints | Baseline up to Week 24 |
| DB Phase: Percentage of Participants With Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score of 0 or 1 at 75% of Timepoints | Baseline up to Week 24 |
| Serum Concentrations of Nipocalimab Over Time | DB Phase: Predose and 45 minutes post-dose on Day 1, Weeks 2, 4, 8, 12,16, 20, 24;OL Phase: Predose on Day 1, Weeks 8, 16, 24, 36, 48, 60, 72, 84, and 96 |
| Number of Participants With Antibodies to Nipocalimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs]) | From start of treatment (Day 1) up to 4 years 9 months |
| Percent Change From Baseline in Total Serum Immunoglobulin G (IgG) Concentrations | Baseline up to 4 years 9 months |
| Change From Baseline in Levels of Autoantibodies Associated With Generalized Myasthenia Gravis (gMG) | Baseline up to 4 years 9 months |
| Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score as a Function of IgG | Baseline up to 4 years 9 months |
| Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score as a Function of Immunoglobulin G (IgG) | Baseline up to 4 years 9 months |
| Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score as a Response to Percent Change in Autoantibody Levels in Seropositive Participants Treated With Nipocalimab | Baseline up to 4 years 9 months |
| Change From Baseline in QMG Score as a Response to Percent Change in Autoantibody Levels in Seropositive Participants Treated With Nipocalimab | Baseline up to 4 years 9 months |
| Sub Study: Number of Participants With Treatment-Emergent AEs | Up to SC Week 8 (Day 57) |
| Sub Study: Number of Participants With Abnormalities in Vital Signs | Up to SC Week 8 (Day 57) |
| Sub Study: Number of Participants With Abnormalities in Physical Examinations | Up to SC Week 8 (Day 57) |
| Sub Study: Number of Participants With Abnormalities in Laboratory Parameters | Up to SC Week 8 (Day 57) |
| Sub Study: Numeric Pain Rating Scale (NPRS) Assessment With SC Use of Nipocalimab | Up to SC Week 8 (Day 57) |
| Sub Study: Number of Participants With Injection Site-Reactions | Up to SC Week 8 (Day 57) |
| Sub Study: Change From Baseline in MG-ADL Clinician-Reported Outcome Measures up to Week 8 (Day 57) | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) |
| Sub Study: Change From Baseline in QMG Clinician-Reported Outcome Measures up to Week 8 (Day 57) | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) |
| Sub Study: Change From Baseline in Myasthenia Gravis Foundation of America (MGFA) Clinician-Reported Measures up to Week 8 (Day 57) | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) |
| Sub Study: Change From Baseline in C-SSRS Clinician-Reported Outcome Measures up to Week 8 (Day 57) | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) |
| Sub Study: Change From Baseline in Neuro-QoL Participant-Reported Outcome Measures up to Week 8 (Day 57) | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) |
| Sub Study: Change From Baseline in Patient Global Impression of Severity (PGIS) Scale Score up to Week 8 (Day 57) | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) |
| Sub Study: Change From Baseline in Patient Global Impression of Change (PGIC) Scale Score up to Week 8 (Day 57) | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) |
| Sub Study: Change From Baseline in MG-QoL Participant-Reported Outcome Measures up to Week 8 (Day 57) | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) |
| Sub Study: Change From Baseline in EQ-5D-5L Participant-Reported Outcome Measures up to Week 8 (Day 57) | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) |
| Sub Study: Percent Change in Total IgG Levels From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57) | From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57) |
| Sub Study: Percent Change in Anti-AChR Autoantibody Titer From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57) | From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57) |
| HonorHealth Neurology |
| Completed |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| University of Southern California | Completed | Los Angeles | California | 90033 | United States |
| Stanford University | Completed | Palo Alto | California | 94304 | United States |
| Care Access Research | Recruiting | Pasadena | California | 91101 | United States |
| University of Colorado Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
| Yale New Haven Hospital | Recruiting | New Haven | Connecticut | 06519 | United States |
| FM Clinical Research, LLC South Florida Neurology Associates, P. A. | Recruiting | Boca Raton | Florida | 33487 | United States |
| University of Florida Health Jacksonville | Completed | Jacksonville | Florida | 32209 | United States |
| Medsol Clinical Research Center Inc | Recruiting | Port Charlotte | Florida | 33952 | United States |
| University of South Florida | Recruiting | Tampa | Florida | 33612 | United States |
| Augusta University | Completed | Augusta | Georgia | 30912-3125 | United States |
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
| St. Elizabeth Medical Center | Completed | Boston | Massachusetts | 02135 | United States |
| Lahey Hospital & Medical Center | Completed | Burlington | Massachusetts | 01805 | United States |
| Washington University School Of Medicine | Completed | St Louis | Missouri | 63110 | United States |
| Duke University School of Medicine | Recruiting | Durham | North Carolina | 27710 | United States |
| University of Cincinnati | Completed | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44145 | United States |
| The Ohio State University | Completed | Columbus | Ohio | 43210 | United States |
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
| Wesley Neurology | Completed | Cordova | Tennessee | 38018 | United States |
| UT Southwestern Medical Center | Completed | Dallas | Texas | 75390 | United States |
| University of Vermont | Completed | Burlington | Vermont | 05401 | United States |
| Melbourne Neurology Group | Completed | North Melbourne | 3051 | Australia |
| Gold Coast University Hospital | Recruiting | Southport | 4215 | Australia |
| ULB Hôpital Erasme | Recruiting | Anderlecht | 1070 | Belgium |
| AZ Sint Jan Brugge Oostende AV | Recruiting | Bruges | 8000 | Belgium |
| Cliniques Universitaires Saint Luc | Recruiting | Brussels | 1200 | Belgium |
| AZ Sint-Lucas | Recruiting | Ghent | 9000 | Belgium |
| University Hospitals Leuven | Recruiting | Leuven | 3000 | Belgium |
| The Ottawa Hospital Research Institute | Recruiting | Ottawa | Ontario | K1Y 4E9 | Canada |
| Toronto General Hospital | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
| McGill University | Completed | Montreal | Quebec | H3A 2B4 | Canada |
| Beijing Tiantan Hospital, Capital Medical University | Recruiting | Beijing | 100050 | China |
| Xuanwu Hospital ,Capital Medical University | Completed | Beijing | 100053 | China |
| Beijing Hospital | Recruiting | Beijing | 100730 | China |
| The First Bethune Hospital of Jilin University | Recruiting | Changchun | 130021 | China |
| Xiangya Hospital Central South University | Recruiting | Changsha | 410008 | China |
| West China Hospital of Sichuan University | Completed | Chengdu | 610041 | China |
| Fujian Medical University Union Hospital | Completed | Fuzhou | 350001 | China |
| The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine | Recruiting | Guangzhou | 510405 | China |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Completed | Hangzhou | 310020 | China |
| Qianfoshan hospital of Shandong Province | Recruiting | Jinan | 250014 | China |
| Qilu Hospital of Shandong University | Completed | Jinan | 250014 | China |
| Huashan Hospital Fudan University | Recruiting | Shanghai | 200040 | China |
| Tianjin Medical University General Hospital | Recruiting | Tianjin | 300052 | China |
| The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital | Recruiting | Xi'an | 710038 | China |
| Neurologie a rehabilitace SkopalÃkova | Recruiting | Brno | 615 00 | Czechia |
| Fakultni nemocnice Brno | Completed | Brno | 625 00 | Czechia |
| Vseobecna Fakultnà Nemocnice | Recruiting | Prague | 12808 | Czechia |
| Aalborg University Hospital | Completed | Aalborg | 9000 | Denmark |
| Rigshospitalet | Completed | København Ø | 2100 | Denmark |
| Hopital Pierre Wertheimer | Recruiting | Bron | 69500 | France |
| CHU Grenoble | Completed | Grenoble | 38043 | France |
| Hopital de la Pitie Salpetriere | Recruiting | Paris | 75013 | France |
| Hopital PASTEUR | Recruiting | Provence-Alpes-Côte d'Azur | 06000 | France |
| Hopital PASTEUR | Completed | Provence-Alpes-Côte d'Azur | 06000 | France |
| NeuroCure Clinical Research Center | Recruiting | Berlin | 10117 | Germany |
| Universitatsmedizin Gottingen | Completed | Göttingen | 37075 | Germany |
| Universitaetsklinikum Leipzig | Completed | Leipzig | 04103 | Germany |
| Universitatsklinikum Schleswig Holstein Campus Lubeck | Completed | Lübeck | 23538 | Germany |
| Universitatsklinikum Ulm | Completed | Ulm | 89081 | Germany |
| DKD HELIOS Klinik Wiesbaden, Fachbereich Neurologie | Completed | Wiesbaden | 65191 | Germany |
| U.O.P.I. di Psichiatria | Completed | Catania | 95100 | Italy |
| Fondazione Istituto G. Giglio | Recruiting | Cefalù | 90015 | Italy |
| Istituto Neurologico Carlo Besta | Recruiting | Milan | 20133 | Italy |
| Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli | Recruiting | Naples | 80138 | Italy |
| IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione | Recruiting | Pavia | 27100 | Italy |
| Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza | Completed | Roma | 00189 | Italy |
| Policlinico Universitario Agostino Gemelli | Recruiting | Roma | 168 | Italy |
| Chiba University Hospital | Completed | Chiba | 260 8677 | Japan |
| General Hanamaki Hospital | Recruiting | Hanamaki | 025-0082 | Japan |
| Hiroshima University Hospital | Recruiting | Hiroshima | 734 8551 | Japan |
| Teikyo University Hospital | Recruiting | Itabashi Ku | 173 8606 | Japan |
| St Marianna University Hospital | Recruiting | Kawasaki Shi | 216 8511 | Japan |
| Kagawa University Hospital | Completed | Kita Gun | 761 0793 | Japan |
| Kumamoto University Hospital | Completed | Kumamoto | 860-8556 | Japan |
| Iwate Medical University Hospital | Recruiting | Morioka | 020-8505 | Japan |
| National Hospital Organization Nagoya Medical Center | Completed | Nagoya | 460-0001 | Japan |
| Niigata City General Hospital | Recruiting | Niigata | 950-1197 | Japan |
| Hyogo College of Medicine Hospital | Recruiting | Nishinomiya-Shi | 663-8501 | Japan |
| Sapporo Medical University Hospital | Completed | Sapporo | 0608556 | Japan |
| Hokkaido Medical Center | Recruiting | Sapporo | 063 0005 | Japan |
| National Hospital Organization Sendai Medical Center | Recruiting | Sendai | 983-8520 | Japan |
| Tokushima University Hospital | Completed | Tokushima | 770-8503 | Japan |
| Tokyo Medical University Hospital | Completed | Tokyo | 160-0023 | Japan |
| iBiomed Research Unit | Completed | Aguascalientes | 20010 | Mexico |
| Consultorio Dr. Miguel Cortes | Recruiting | Cuernavaca | 62448 | Mexico |
| Hospital Civil de Guadalajara Fray Antonio Alcalde | Recruiting | Guadalajara | 44280 | Mexico |
| Neurocentrum Bydgoszcz Sp Z O O | Recruiting | Bydgoszcz | 85 796 | Poland |
| NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis' | Recruiting | Katowice | 40-123 | Poland |
| Centrum Neurologii Klinicznej Krakowska Akademia Neurologii | Recruiting | Krakow | 31 505 | Poland |
| Prywatny Gabinet Lekarski | Recruiting | Lublin | 20 093 | Poland |
| Centrum Medyczne NeuroProtect | Recruiting | Warsaw | 01-684 | Poland |
| Pusan National University Hospital | Recruiting | Busan | 49241 | South Korea |
| Kyungpook National University Chilgok Hospital | Recruiting | Daegu | 41404 | South Korea |
| Kyungpook National University Hospital | Completed | Daegu | 41944 | South Korea |
| Severance Hospital Yonsei University Health System | Recruiting | Seoul | 120-752 | South Korea |
| Hosp. Gral. Univ. de Alicante | Recruiting | Alicante | 03010 | Spain |
| Hosp. de La Santa Creu I Sant Pau | Recruiting | Barcelona | 08025 | Spain |
| Hosp Univ Vall D Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hosp Clinic de Barcelona | Recruiting | Barcelona | 8036 | Spain |
| Hosp. Univ. de Basurto | Recruiting | Bilbao | 48013 | Spain |
| Hosp. Virgen Macarena | Recruiting | Seville | 41009 | Spain |
| Hosp. Virgen Del Rocio | Completed | Seville | 41013 | Spain |
| Hosp. Univ. I Politecni La Fe | Recruiting | Valencia | 46026 | Spain |
| Karlstad Central Hospital | Completed | Karlstad | 651 85 | Sweden |
| Karolinska Universitetssjukhuset Solna | Recruiting | Stockholm | 171 76 | Sweden |
| China Medical University Hospital | Completed | Taichung | 40447 | Taiwan |
| Shin Kong Wu Ho Su Memorial Hospital | Recruiting | Taipei | 111 | Taiwan |
| Taipei Veterans General Hospital | Recruiting | Taipei | 11217 | Taiwan |
| Derived |
| Antozzi C, Fitzgibbon M. An evaluation of nipocalimab for the treatment of generalized myasthenia gravis. Expert Opin Biol Ther. 2025 Oct;25(10):1047-1058. doi: 10.1080/14712598.2025.2561935. Epub 2025 Sep 30. |
| 40515798 | Derived | Raborn A, Savord A, Houts CR, Pease S, Scippa K, Ramchandren S. Psychometric analysis of the Neuro-QoL Fatigue in generalized Myasthenia Gravis (gMG) using data from a phase 3 trial. Qual Life Res. 2025 Sep;34(9):2577-2589. doi: 10.1007/s11136-025-03998-9. Epub 2025 Jun 14. |
| 39862879 | Derived | Antozzi C, Vu T, Ramchandren S, Nowak RJ, Farmakidis C, Bril V, De Bleecker J, Yang H, Minks E, Park JS, Grudniak M, Smilowski M, Sevilla T, Hoffmann S, Sivakumar K, Suzuki Y, Youssef E, Sanga P, Karcher K, Zhu Y, Sheehan JJ, Sun H; Vivacity-MG3 Study Group. Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2025 Feb;24(2):105-116. doi: 10.1016/S1474-4422(24)00498-8. |
| DB Phase: Nipocalimab |
During DB phase, participants of present study received nipocalimab 30 milligrams per kilogram (mg/kg) IV infusion as a loading dose on Day 1 (Week 0) followed by nipocalimab 15 mg/kg IV infusion as maintenance dose once q2w from Week 2 up to Week 24. |
| FG002 | OLE Phase: Placebo to Nipocalimab | Present study participants who received placebo and completed DB phase entered OLE phase and received nipocalimab 15 mg/kg IV infusion q2w from OLE phase Day 1. Participants who discontinued DB treatment phase due to use of rescue medication for myasthenia gravis exacerbation or crisis were also eligible to enter the OLE phase. |
| FG003 | OLE Phase: Nipocalimab | Present study participants who received nipocalimab and completed DB phase entered OLE phase and received nipocalimab 15 mg/kg IV infusion q2w from OLE phase Day 1. Participants who discontinued DB treatment phase due to use of rescue medication for myasthenia gravis exacerbation or crisis were also eligible to enter the OLE phase. |
| FG004 | OLE Phase: Nipocalimab (MOM-M281-004 and MOM-M281-005) | Participants who received nipocalimab in studies MOM-M281-004 (NCT03772587) and MOM-M281-005 (NCT03896295) entered OLE phase of the present study and received nipocalimab 15 mg/kg IV infusion q2w from OLE phase Day 1. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| OLE: Week 24 (OLE Day 1) up to 2 Years |
|
|
The full analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention in the double-blind phase. The safety analysis set (OL) included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Double Blind (DB) Phase: Placebo | During double blind (DB) phase, participants of present study received placebo matching to nipocalimab intravenous (IV) infusion as a loading dose on Day 1 (Week 0) followed by placebo matching to nipocalimab IV infusion as maintenance dose once every 2 weeks (q2w) from Week 2 up to Week 24. |
| BG001 | DB Phase: Nipocalimab | During DB phase, participants of present study received nipocalimab 30 milligrams per kilogram (mg/kg) IV infusion as a loading dose on Day 1 (Week 0) followed by nipocalimab 15 mg/kg IV infusion as maintenance dose once q2w from Week 2 up to Week 24. |
| BG002 | OLE Phase: Nipocalimab (MOM-M281-004 and MOM-M281-005) | Participants who received nipocalimab in studies MOM-M281-004 (NCT03772587) and MOM-M281-005 (NCT03896295) entered OLE phase of the present study and received nipocalimab 15 mg/kg IV infusion q2w from OLE phase Day 1. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Double-blind (DB) Phase: Average Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24 | Average change from baseline over multiple timepoints (Weeks 22, 23, and 24) was reported in this outcome measure. The MG-ADL provided a rapid assessment of the participant's MG symptom severity of 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) rated on a 4-point scale ranging from 0 (normal) to 3 (severe). MG-ADL total score was sum of 8 individual items, which ranging from 0 to 24. A higher score indicated greater symptom severity. Baseline was defined as the average of the screening and Day 1 total scores. | Primary efficacy analysis set included all randomized seropositive (with anti- acetylcholine receptor positive, anti muscle-specific kinase positive, and/or anti- lipoprotein-related protein receptor 4 positive) participants who received at least 1 dose (partial or complete) of any study intervention in the double-blind phase. Here, 'N' (overall number of participants analysed) signifies participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, Weeks 22, 23, and 24 |
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| Secondary | DB Phase: Average Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score Over Weeks 22 and 24 | Not Posted | Apr 2027 | Baseline, Weeks 22, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DB Phase: Percentage of Participants Who Had Achieved at Least a 2-point Average Improvement From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24 | Not Posted | Apr 2027 | Weeks 22, 23, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DB Phase: Percentage of Participants Who Had Achieved an Improvement of Greater Than or Equal to (>=) 2 Points in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score at Week 1 and/or Week 2 | Not Posted | Apr 2027 | Weeks 1 and 2 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DB Phase: Percentage of Participants Who Had an Improvement of >= 2 Points in the MG-ADL Total Score From Week 4 Through Week 24 With no More Than 2 Non-consecutive Excursions Allowed Between Weeks 6 Through 23 | Not Posted | Apr 2027 | From Week 4 up to Week 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DB Phase: Percentage of Participants Who Had Achieved at Least a 50 Percent (%) Average Improvement From Baseline in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24 | Not Posted | Apr 2027 | Weeks 22, 23, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Not Posted | Apr 2027 | From start of treatment (DB phase Day 1) up to 4 years 9 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | Not Posted | Apr 2027 | From start of treatment (DB phase Day 1) up to 4 years 9 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With AEs of Special Interest (AESIs) | Not Posted | Apr 2027 | From start of treatment (DB phase Day 1) up to 4 years 9 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Change in Vital Signs | Not Posted | Apr 2027 | From start of treatment (DB phase Day 1) up to 4 years 9 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Change in Clinical Laboratory Values | Not Posted | Apr 2027 | From start of treatment (DB phase Day 1) up to 4 years 9 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Not Posted | Apr 2027 | From start of treatment (Day 1) up to 4 years 9 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DB Phase: Percentage of Participants Who Had an Improvement of >= 3 Points in Quantitative Myasthenia Gravis (QMG) Score From Baseline, at Week 2 Through Week 24, With No More Than 2 Non-consecutive Excursions Allowed Between at Weeks 4 Through Week 22 | Not Posted | Apr 2027 | Baseline, Week 2 up to Week 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DB Phase: Average Change From Baseline in the Fatigue Items of the Quality of Life in Neurological Disorders (Neuro-QoL) Fatigue Scale Total Score Over Weeks 22 and 24 | Not Posted | Apr 2027 | Baseline up to Weeks 22, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DB Phase: Average Change From Baseline in the Revised Myasthenia Gravis Quality of Life (Revised) Instrument (MG-Qol15r) Score Over Weeks 22 And 24 | Not Posted | Apr 2027 | Baseline up to Weeks 22, and 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DB Phase: 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 | Not Posted | Apr 2027 | Baseline up to Week 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DB Phase: Change From Baseline in the Health Status Index of the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scale Over 24 Weeks | Not Posted | Apr 2027 | Baseline up to Week 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DB Phase: Percentage of Participants With Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score of 0 or 1 Over Time | Not Posted | Apr 2027 | Baseline up to Week 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DB Phase: Percentage of Participants With Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score of 0 or 1 at Any Time | Not Posted | Apr 2027 | Baseline up to Week 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DB Phase: Percentage of Participants With Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score of 0 or 1 at 50% of Timepoints | Not Posted | Apr 2027 | Baseline up to Week 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DB Phase: Percentage of Participants With Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score of 0 or 1 at 75% of Timepoints | Not Posted | Apr 2027 | Baseline up to Week 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Concentrations of Nipocalimab Over Time | Not Posted | Apr 2027 | DB Phase: Predose and 45 minutes post-dose on Day 1, Weeks 2, 4, 8, 12,16, 20, 24;OL Phase: Predose on Day 1, Weeks 8, 16, 24, 36, 48, 60, 72, 84, and 96 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Antibodies to Nipocalimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs]) | Not Posted | Apr 2027 | From start of treatment (Day 1) up to 4 years 9 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Total Serum Immunoglobulin G (IgG) Concentrations | Not Posted | Apr 2027 | Baseline up to 4 years 9 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Levels of Autoantibodies Associated With Generalized Myasthenia Gravis (gMG) | Not Posted | Apr 2027 | Baseline up to 4 years 9 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score as a Function of IgG | Not Posted | Apr 2027 | Baseline up to 4 years 9 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score as a Function of Immunoglobulin G (IgG) | Not Posted | Apr 2027 | Baseline up to 4 years 9 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score as a Response to Percent Change in Autoantibody Levels in Seropositive Participants Treated With Nipocalimab | Not Posted | Apr 2027 | Baseline up to 4 years 9 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in QMG Score as a Response to Percent Change in Autoantibody Levels in Seropositive Participants Treated With Nipocalimab | Not Posted | Apr 2027 | Baseline up to 4 years 9 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Sub Study: Percent Change in Anti-AChR Autoantibody Titer From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57) | Not Posted | Apr 2027 | From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Sub Study: Percent Change in Total IgG Levels From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57) | Not Posted | Apr 2027 | From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sub Study: Number of Participants With Treatment-Emergent AEs | Not Posted | Apr 2027 | Up to SC Week 8 (Day 57) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sub Study: Number of Participants With Abnormalities in Vital Signs | Not Posted | Apr 2027 | Up to SC Week 8 (Day 57) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sub Study: Number of Participants With Abnormalities in Physical Examinations | Not Posted | Apr 2027 | Up to SC Week 8 (Day 57) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sub Study: Number of Participants With Abnormalities in Laboratory Parameters | Not Posted | Apr 2027 | Up to SC Week 8 (Day 57) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sub Study: Numeric Pain Rating Scale (NPRS) Assessment With SC Use of Nipocalimab | Not Posted | Apr 2027 | Up to SC Week 8 (Day 57) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sub Study: Number of Participants With Injection Site-Reactions | Not Posted | Apr 2027 | Up to SC Week 8 (Day 57) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sub Study: Change From Baseline in MG-ADL Clinician-Reported Outcome Measures up to Week 8 (Day 57) | Not Posted | Apr 2027 | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sub Study: Change From Baseline in QMG Clinician-Reported Outcome Measures up to Week 8 (Day 57) | Not Posted | Apr 2027 | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sub Study: Change From Baseline in Myasthenia Gravis Foundation of America (MGFA) Clinician-Reported Measures up to Week 8 (Day 57) | Not Posted | Apr 2027 | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sub Study: Change From Baseline in C-SSRS Clinician-Reported Outcome Measures up to Week 8 (Day 57) | Not Posted | Apr 2027 | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sub Study: Change From Baseline in Neuro-QoL Participant-Reported Outcome Measures up to Week 8 (Day 57) | Not Posted | Apr 2027 | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sub Study: Change From Baseline in Patient Global Impression of Severity (PGIS) Scale Score up to Week 8 (Day 57) | Not Posted | Apr 2027 | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sub Study: Change From Baseline in Patient Global Impression of Change (PGIC) Scale Score up to Week 8 (Day 57) | Not Posted | Apr 2027 | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sub Study: Change From Baseline in MG-QoL Participant-Reported Outcome Measures up to Week 8 (Day 57) | Not Posted | Apr 2027 | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sub Study: Change From Baseline in EQ-5D-5L Participant-Reported Outcome Measures up to Week 8 (Day 57) | Not Posted | Apr 2027 | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sub Study: Percent Change in Total IgG Levels From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57) | Not Posted | Apr 2027 | From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sub Study: Percent Change in Anti-AChR Autoantibody Titer From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57) | Not Posted | Apr 2027 | From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57) | Participants |
DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Double Blind (DB) Phase: Placebo | During double blind (DB) phase, participants of present study received placebo matching to nipocalimab intravenous (IV) infusion as a loading dose on Day 1 (Week 0) followed by placebo matching to nipocalimab IV infusion as maintenance dose once every 2 weeks (q2w) from Week 2 up to Week 24. | 2 | 99 | 14 | 98 | 65 | 98 |
| EG001 | DB Phase: Nipocalimab | During DB phase, participants of present study received nipocalimab 30 milligrams per kilogram (mg/kg) IV infusion as a loading dose on Day 1 (Week 0) followed by nipocalimab 15 mg/kg IV infusion as maintenance dose once q2w from Week 2 up to Week 24. | 1 | 100 | 9 | 98 | 69 | 98 |
| EG002 | OLE Phase: Placebo to Nipocalimab | Present study participants who received placebo and completed DB phase entered OLE phase and received nipocalimab 15 mg/kg IV infusion q2w from OLE phase Day 1. Participants who discontinued DB treatment phase due to use of rescue medication for myasthenia gravis exacerbation or crisis were also eligible to enter the OLE phase. | 1 | 88 | 10 | 88 | 57 | 88 |
| EG003 | OLE Phase: Nipocalimab | Present study participants who received nipocalimab and completed DB phase entered OLE phase and received nipocalimab 15 mg/kg IV infusion q2w from OLE phase Day 1. Participants who discontinued DB treatment phase due to use of rescue medication for myasthenia gravis exacerbation or crisis were also eligible to enter the OLE phase. | 1 | 88 | 16 | 88 | 59 | 88 |
| EG004 | OLE Phase: Nipocalimab (MOMM281- 004 and MOM-M281-005) | Participants who received nipocalimab in studies MOM-M281-004 (NCT03772587) and MOM-M281-005 (NCT03896295) entered OLE phase of the present study and received nipocalimab 15 mg/kg IV infusion q2w from OLE phase Day 1. | 1 | 19 | 7 | 19 | 18 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Angina Pectoris | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Atrioventricular Block Complete | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Cardiogenic Shock | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Hypertensive Heart Disease | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Myocardial Ischaemia | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Grey Matter Heterotopia | Congenital, familial and genetic disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Eyelid Pain | Eye disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Haemorrhoidal Haemorrhage | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Cholecystitis Acute | Hepatobiliary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Liver Disorder | Hepatobiliary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Anaphylactic Shock | Immune system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Haemophagocytic Lymphohistiocytosis | Immune system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Coronavirus Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Escherichia Bacteraemia | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Gastroenteritis Salmonella | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Herpes Zoster Oticus | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Perinephric Abscess | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Pneumonia Aspiration | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Pneumonia Bacterial | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Femur Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
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| Hip Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
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| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
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| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
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| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
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| Papillary Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
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| Parathyroid Tumour Benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
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| Squamous Cell Carcinoma of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
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| Thymoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
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| Cerebral Haemorrhage | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Intracranial Mass | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Myasthenia Gravis | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Myasthenia Gravis Crisis | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Non-Epileptic Paroxysmal Event | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Toxic Encephalopathy | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Major Depression | Psychiatric disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Suicidal Ideation | Psychiatric disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Suicide Attempt | Psychiatric disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Nephropathy | Renal and urinary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Renal Tubular Necrosis | Renal and urinary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| White Blood Cell Disorder | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Bundle Branch Block Left | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Otorrhoea | Ear and labyrinth disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Thyroid Mass | Endocrine disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Angle Closure Glaucoma | Eye disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Eye Pain | Eye disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Eyelid Ptosis | Eye disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Diverticulum Intestinal | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Food Poisoning | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Catheter Site Erythema | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cyst | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Infusion Site Bruising | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Infusion Site Erythema | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Infusion Site Extravasation | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Peripheral Swelling | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Secretion Discharge | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Swelling | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Swelling Face | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hepatic Cyst | Hepatobiliary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hepatic Steatosis | Hepatobiliary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Seasonal Allergy | Immune system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Covid-19 Pneumonia | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Gastric Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Gastrointestinal Viral Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Helicobacter Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Herpes Ophthalmic | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Tooth Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Viral Diarrhoea | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Animal Bite | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Arthropod Bite | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Limb Injury | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Muscle Hernia | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Muscle Injury | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Skin Injury | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Wrist Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Blood Cholesterol Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| C-Reactive Protein Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Haemoglobin Decreased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Intraocular Pressure Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Low Density Lipoprotein Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Monocyte Count Decreased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Neutrophil Count Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Sars-Cov-2 Test Positive | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Glucose Tolerance Impaired | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Iron Deficiency | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Vitamin D Deficiency | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Medial Tibial Stress Syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Spinal Deformity | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Synovial Cyst | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Diabetic Neuropathy | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Dizziness Postural | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Loss of Consciousness | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Lumbar Radiculopathy | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Myasthenia Gravis | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Major Depression | Psychiatric disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Urinary Incontinence | Renal and urinary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Breast Haematoma | Reproductive system and breast disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pulmonary Mass | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Perioral Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 8, 2023 | May 27, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Death |
|
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Ongoing |
|
| Met eligibility criteria but discontinued during the screening period (not treated) |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|