A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

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.

Study Overview

• Status: Recruiting
• Conditions: Myasthenia Gravis
• Intervention / Treatment: Drug: Nipocalimab; Drug: Placebo; Drug: Nipocalimab SC-LIV

Detailed Description

Myasthenia gravis (MG) is a rare, heterogeneous, neuromuscular disease characterized by fluctuating, fatigable muscle weakness. MG is caused by pathogenic autoantibodies that impair cholinergic transmission in the postsynaptic membrane at the neuromuscular junction and impair or prevent muscle contraction. Nipocalimab (also referred to as JNJ-80202135 or M281) is a fully human, aglycosylated immunoglobulin (Ig)G1 monoclonal antibody (mAb) designed to selectively bind, saturate, and block the IgG binding site on the endogenous neonatal Fc receptor (FcRn). This study will consist of a screening phase (up to 4 weeks), treatment phase (a 24-week double-blind placebo-controlled phase, and an open-label extension [OLE] phase [up to 2 years]) and a follow-up safety visit (up to 8 weeks after last infusion of study intervention). Efficacy evaluations will include assessments such as Myasthenia Gravis - Activities of Daily Living (MG-ADL) score. Safety evaluations (such as adverse events, physical examination, vital signs, electrocardiogram [ECG], and clinical laboratory tests) will be performed. The overall duration of study will be up to 4 years and 8 months.

• Study Type: Interventional
• Enrollment (Estimated): 199
• Phase: Phase 3

Expanded Access

Temporarily not available outside the clinical trial. See expanded access record.

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• Australia
  • North Melbourne, Australia, 3051
    • Completed
    • Melbourne Neurology Group
  • Southport, Australia, 4215
    • Recruiting
    • Gold Coast University Hospital
• Belgium
  • Anderlecht, Belgium, 1070
    • Recruiting
    • ULB Hopital Erasme
  • Bruges, Belgium, 8000
    • Recruiting
    • AZ Sint Jan Brugge Oostende AV
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint Luc
  • Ghent, Belgium, 9000
    • Recruiting
    • AZ Sint-Lucas
  • Leuven, Belgium, 3000
    • Recruiting
    • University Hospitals Leuven
• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
      • Recruiting
      • The Ottawa Hospital Research Institute
    • Toronto, Ontario, Canada, M5G 2C4
      • Recruiting
      • Toronto General Hospital
  • Quebec
    • Montreal, Quebec, Canada, H3A 2B4
      • Completed
      • McGill University
• China
  • Beijing, China, 100730
    • Recruiting
    • Beijing Hospital
  • Beijing, China, 100050
    • Recruiting
    • Beijing Tiantan Hospital, Capital Medical University
  • Beijing, China, 100053
    • Completed
    • Xuanwu Hospital ,Capital Medical University
  • Changchun, China, 130021
    • Recruiting
    • The First Bethune Hospital of Jilin University
  • Changsha, China, 410008
    • Recruiting
    • Xiangya Hospital Central South University
  • Chengdu, China, 610041
    • Completed
    • West China Hospital of Sichuan University
  • Fuzhou, China, 350001
    • Completed
    • Fujian Medical University Union Hospital
  • Guangzhou, China, 510405
    • Recruiting
    • The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
  • Hangzhou, China, 310020
    • Completed
    • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
  • Jinan, China, 250014
    • Recruiting
    • Qianfoshan hospital of Shandong Province
  • Jinan, China, 250014
    • Completed
    • Qilu Hospital of Shandong University
  • Shanghai, China, 200040
    • Recruiting
    • Huashan Hospital Fudan University
  • Tianjin, China, 300052
    • Recruiting
    • Tianjin Medical University General Hospital
  • Xi'an, China, 710038
    • Recruiting
    • The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital
• Czechia
  • Brno, Czechia, 615 00
    • Recruiting
    • Neurologie a rehabilitace Skopalíkova
  • Brno, Czechia, 625 00
    • Completed
    • Fakultni nemocnice Brno
  • Prague, Czechia, 12808
    • Recruiting
    • Vseobecna Fakultni Nemocnice
• Denmark
  • Aalborg, Denmark, 9000
    • Completed
    • Aalborg University Hospital
  • København Ø, Denmark, 2100
    • Completed
    • Rigshospitalet
• France
  • Bron, France, 69500
    • Recruiting
    • Hôpital Pierre Wertheimer
  • Grenoble, France, 38043
    • Completed
    • CHU Grenoble
  • Paris, France, 75013
    • Recruiting
    • Hopital de La Pitie Salpetriere
  • Provence-Alpes-Côte d'Azur, France, 06000
    • Recruiting
    • Hôpital Pasteur
  • Provence-Alpes-Côte d'Azur, France, 06000
    • Completed
    • Hôpital Pasteur
• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • NeuroCure Clinical Research Center
  • Göttingen, Germany, 37075
    • Completed
    • Universitätsmedizin Göttingen
  • Leipzig, Germany, 04103
    • Completed
    • Universitaetsklinikum Leipzig
  • Lübeck, Germany, 23538
    • Completed
    • Universitatsklinikum Schleswig Holstein Campus Lubeck
  • Ulm, Germany, 89081
    • Completed
    • Universitatsklinikum Ulm
  • Wiesbaden, Germany, 65191
    • Completed
    • DKD HELIOS Klinik Wiesbaden, Fachbereich Neurologie
• Italy
  • Catania, Italy, 95100
    • Completed
    • U.O.P.I. di Psichiatria
  • Cefalù, Italy, 90015
    • Recruiting
    • Fondazione Istituto G. Giglio
  • Milan, Italy, 20133
    • Recruiting
    • Istituto Neurologico Carlo Besta
  • Napoli, Italy, 80138
    • Recruiting
    • Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
  • Pavia, Italy, 27100
    • Recruiting
    • IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione
  • Roma, Italy, 168
    • Recruiting
    • Policlinico Universitario Agostino Gemelli
  • Roma, Italy, 00189
    • Completed
    • Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza
• Japan
  • Chiba, Japan, 260 8677
    • Completed
    • Chiba University Hospital
  • Hanamaki, Japan, 025-0082
    • Recruiting
    • General Hanamaki Hospital
  • Hiroshima, Japan, 734 8551
    • Recruiting
    • Hiroshima University Hospital
  • Itabashi Ku, Japan, 173 8606
    • Recruiting
    • Teikyo University Hospital
  • Kawasaki Shi, Japan, 216 8511
    • Recruiting
    • St Marianna University Hospital
  • Kita Gun, Japan, 761 0793
    • Completed
    • Kagawa University Hospital
  • Kumamoto, Japan, 860-8556
    • Completed
    • Kumamoto University Hospital
  • Morioka, Japan, 020-8505
    • Recruiting
    • Iwate Medical University Hospital
  • Nagoya, Japan, 460-0001
    • Completed
    • National Hospital Organization Nagoya Medical Center
  • Niigata, Japan, 950-1197
    • Recruiting
    • Niigata City General Hospital
  • Nishinomiya-Shi, Japan, 663-8501
    • Recruiting
    • Hyogo College of Medicine Hospital
  • Sapporo, Japan, 063 0005
    • Recruiting
    • Hokkaido Medical Center
  • Sapporo, Japan, 0608556
    • Completed
    • Sapporo Medical University Hospital
  • Sendai, Japan, 983-8520
    • Recruiting
    • National Hospital Organization Sendai Medical Center
  • Tokushima, Japan, 770-8503
    • Completed
    • Tokushima University Hospital
  • Tokyo, Japan, 160-0023
    • Completed
    • Tokyo Medical University Hospital
• Mexico
  • Aguascalientes, Mexico, 20010
    • Completed
    • iBiomed Research Unit
  • Cuernavaca, Mexico, 62448
    • Recruiting
    • Consultorio Dr. Miguel Cortes
  • Guadalajara, Mexico, 44280
    • Recruiting
    • Hospital Civil de Guadalajara Fray Antonio Alcalde
• Poland
  • Bydgoszcz, Poland, 85 796
    • Recruiting
    • Neurocentrum Bydgoszcz Sp Z O O
  • Katowice, Poland, 40-123
    • Recruiting
    • NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'
  • Krakow, Poland, 31 505
    • Recruiting
    • Centrum Neurologii Klinicznej Krakowska Akademia Neurologii
  • Lublin, Poland, 20 093
    • Recruiting
    • Prywatny Gabinet Lekarski
  • Warsaw, Poland, 01-684
    • Recruiting
    • Centrum Medyczne NeuroProtect
• South Korea
  • Busan, South Korea, 49241
    • Recruiting
    • Pusan National University Hospital
  • Daegu, South Korea, 41404
    • Recruiting
    • Kyungpook National University Chilgok Hospital
  • Daegu, South Korea, 41944
    • Completed
    • Kyungpook National University Hospital
  • Seoul, South Korea, 120-752
    • Recruiting
    • Severance Hospital Yonsei University Health System
• Spain
  • Alicante, Spain, 03010
    • Recruiting
    • Hosp. Gral. Univ. de Alicante
  • Barcelona, Spain, 08025
    • Recruiting
    • Hosp. de La Santa Creu I Sant Pau
  • Barcelona, Spain, 8036
    • Recruiting
    • Hosp Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Recruiting
    • Hosp Univ Vall D Hebron
  • Bilbao, Spain, 48013
    • Recruiting
    • Hosp. Univ. de Basurto
  • Seville, Spain, 41013
    • Completed
    • Hosp. Virgen Del Rocio
  • Seville, Spain, 41009
    • Recruiting
    • Hosp. Virgen Macarena
  • Valencia, Spain, 46026
    • Recruiting
    • Hosp. Univ. I Politecni La Fe
• Sweden
  • Karlstad, Sweden, 651 85
    • Completed
    • Karlstad Central Hospital
  • Stockholm, Sweden, 171 76
    • Recruiting
    • Karolinska Universitetssjukhuset Solna
• Taiwan
  • Taichung, Taiwan, 40447
    • Completed
    • China Medical University Hospital
  • Taipei, Taiwan, 11217
    • Recruiting
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 111
    • Recruiting
    • Shin Kong Wu Ho Su Memorial Hospital
• United States
  • Arizona
    • Paradise Valley, Arizona, United States, 85028
      • Recruiting
      • Neuromuscular Research Center and Clinic
    • Scottsdale, Arizona, United States, 85251
      • Completed
      • HonorHealth Neurology
  • California
    • Los Angeles, California, United States, 90033
      • Completed
      • University of Southern California
    • Palo Alto, California, United States, 94304
      • Completed
      • Stanford University
    • Pasadena, California, United States, 91101
      • Recruiting
      • Care Access Research
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • Yale New Haven Hospital
  • Florida
    • Boca Raton, Florida, United States, 33487
      • Recruiting
      • FM Clinical Research, LLC South Florida Neurology Associates, P. A.
    • Jacksonville, Florida, United States, 32209
      • Completed
      • University of Florida Health Jacksonville
    • Port Charlotte, Florida, United States, 33952
      • Recruiting
      • Medsol Clinical Research Center Inc
    • Tampa, Florida, United States, 33612
      • Recruiting
      • University of South Florida
  • Georgia
    • Augusta, Georgia, United States, 30912-3125
      • Completed
      • Augusta University
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02135
      • Completed
      • St. Elizabeth Medical Center
    • Burlington, Massachusetts, United States, 01805
      • Completed
      • Lahey Hospital & Medical Center
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Completed
      • Washington University School of Medicine
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University School of Medicine
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Completed
      • University of Cincinnati
    • Cleveland, Ohio, United States, 44145
      • Recruiting
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • Completed
      • The Ohio State University
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Completed
      • Wesley Neurology
  • Texas
    • Dallas, Texas, United States, 75390
      • Completed
      • UT Southwestern Medical Center
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Completed
      • University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized myasthenia gravis (gMG) as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II a/b, III a/b, or IVa/b at screening
• Myasthenia Gravis - Activities of Daily Living (MG-ADL) score of greater than or equal to (>=) 6 at screening and baseline
• Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol
• A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test at Day 1 prior to administration of study intervention
• A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last administration of study intervention
• For the SC Substudy (Cohort 1 and Cohort 2): Has reasonable abdominal skin area for SC administration
• For the SC Substudy (Cohort 1 and Cohort 2): Participants must be willing to comply with maintaining their stable dose of corticosteroids and/or immunosuppressants for the initial 8 weeks of the SC substudy, that is, through the SC Week 8 visit

Exclusion Criteria:

• Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her gMG, or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
• Has MGFA Class I disease or presence of MG crisis (MGFA Class V) at screening, history of MG crisis within 1 month of screening, or fixed weakness (and/or 'burnt out' MG)
• Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the study
• Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
• Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening
• For the SC Substudy (Cohort 1): Participants who have undergone a recent tapering of their concomitant MG medication in the OLE
• For the SC Substudy (Cohort 1): Participants deteriorating during the OLE in the month prior to SC Dose 1 of the SC substudy such that they meet the criteria for clinical deterioration
• For the SC Substudy (Cohort 2): History of an unprovoked pulmonary embolism within 1 year prior to screening or history of recurrent deep vein thrombosis (DVT)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Placebo; Matching placebo will be administered as an IV infusion.
Experimental: Nipocalimab Subcutaneous (SC); 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.	Drug: Nipocalimab SC-LIV; Nipocalimab will be administered subcutaneously.
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 will have the option to continue to receive nipocalimab q2w IV infusion till study end or enter the nipocalimab SC substudy.	Drug: Nipocalimab; Nipocalimab will be administered as an IV infusion.; Other Names: JNJ-80202135, M281

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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: 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)
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)

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Actual): November 17, 2023
• Study Completion (Estimated): March 30, 2029

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Neurodegenerative Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Neuromuscular Junction Diseases; Myasthenia Gravis; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: CR109046; 2020-005732-29 (EudraCT Number); MOM-M281-011 (Other Identifier: Janssen Research & Development, LLC); 2023-504152-97-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No