Myasthenia GravisPhase 3NCT04951622
A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
A Phase 3 study testing Nipocalimab and Nipocalimab SC-LIV in people with Myasthenia Gravis, run by Janssen Research & Development, LLC at 112 sites in 17 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- Nipocalimab and Nipocalimab SC-LIV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 199 participants
- Where
- 112 sitesin 17 countries
- Study dates
- 15 Jul 2021to 29 Mar 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
112 sites in 17 countries. Contact the study team or a site near you to ask about taking part.
112 sites in 17 countries
United States24 sites, 11 recruiting
- Completed
Augusta University
Augusta, Georgia, 30912-3125
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
- Recruiting
FM Clinical Research, LLC South Florida Neurology Associates, P. A.
Boca Raton, Florida, 33487
- Completed
St. Elizabeth Medical Center
Boston, Massachusetts, 02135
- Completed
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
- Completed
University of Vermont
Burlington, Vermont, 05401
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
- Completed
University of Cincinnati
Cincinnati, Ohio, 45219
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44145
- Completed
The Ohio State University
Columbus, Ohio, 43210
- Completed
Wesley Neurology
Cordova, Tennessee, 38018
- Completed
UT Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
Duke University School of Medicine
Durham, North Carolina, 27710
- Completed
University of Florida Health Jacksonville
Jacksonville, Florida, 32209
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
- Completed
University of Southern California
Los Angeles, California, 90033
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06519
- Completed
Stanford University
Palo Alto, California, 94304
- Recruiting
Neuromuscular Research Center and Clinic
Paradise Valley, Arizona, 85028
- Recruiting
Care Access Research
Pasadena, California, 91101
- Recruiting
Medsol Clinical Research Center Inc
Port Charlotte, Florida, 33952
- Completed
HonorHealth Neurology
Scottsdale, Arizona, 85251
- Completed
Washington University School Of Medicine
St Louis, Missouri, 63110
- Recruiting
University of South Florida
Tampa, Florida, 33612
Japan16 sites, 9 recruiting
- Completed
Chiba University Hospital
Chiba, 260 8677
- Recruiting
General Hanamaki Hospital
Hanamaki, 025-0082
- Recruiting
Hiroshima University Hospital
Hiroshima, 734 8551
- Recruiting
Teikyo University Hospital
Itabashi Ku, 173 8606
- Recruiting
St Marianna University Hospital
Kawasaki Shi, 216 8511
- Completed
Kagawa University Hospital
Kita Gun, 761 0793
- Completed
Kumamoto University Hospital
Kumamoto, 860-8556
- Completed
National Hospital Organization Nagoya Medical Center
Nagoya, 460-0001
- Recruiting
Niigata City General Hospital
Niigata, 950-1197
- Recruiting
Hyogo College of Medicine Hospital
Nishinomiya-Shi, 663-8501
- Completed
Sapporo Medical University Hospital
Sapporo, 0608556
- Recruiting
Hokkaido Medical Center
Sapporo, 063 0005
- Recruiting
National Hospital Organization Sendai Medical Center
Sendai, 983-8520
- Recruiting
Iwate Medical University Hospital
Shiwa-gun, 028-3695
- Completed
Tokushima University Hospital
Tokushima, 770-8503
- Completed
Tokyo Medical University Hospital
Tokyo, 160-0023
China14 sites, 9 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100050
- Completed
Xuanwu Hospital ,Capital Medical University
Beijing, 100053
- Recruiting
Beijing Hospital
Beijing, 100730
- Recruiting
The First Bethune Hospital of Jilin University
Changchun, 130021
- Recruiting
Xiangya Hospital Central South University
Changsha, 410008
- Completed
West China Hospital of Sichuan University
Chengdu, 610041
- Completed
Fujian Medical University Union Hospital
Fuzhou, 350001
- Recruiting
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, 510405
- Completed
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310020
- Recruiting
Qianfoshan hospital of Shandong Province
Jinan, 250014
- Completed
Qilu Hospital of Shandong University
Jinan, 250014
- Recruiting
Huashan Hospital Fudan University
Shanghai, 200040
- Recruiting
Tianjin Medical University General Hospital
Tianjin, 300052
- Recruiting
The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital
Xi'an, 710038
Spain8 sites, 7 recruiting
- Recruiting
Hosp. Gral. Univ. de Alicante
Alicante, 03010
- Recruiting
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08025
- Recruiting
Hosp Univ Vall D Hebron
Barcelona, 08035
- Recruiting
Hosp Clinic de Barcelona
Barcelona, 8036
- Recruiting
Hosp. Univ. de Basurto
Bilbao, 48013
- Recruiting
Hosp. Virgen Macarena
Seville, 41009
- Completed
Hosp. Virgen Del Rocio
Seville, 41013
- Recruiting
Hosp. Univ. I Politecni La Fe
Valencia, 46026
Italy7 sites, 5 recruiting
- Completed
U.O.P.I. di Psichiatria
Catania, 95100
- Recruiting
Fondazione Istituto G. Giglio
Cefalù, 90015
- Recruiting
Istituto Neurologico Carlo Besta
Milan, 20133
- Recruiting
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
Naples, 80138
- Recruiting
IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione
Pavia, 27100
- Completed
Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza
Roma, 00189
- Recruiting
Policlinico Universitario Agostino Gemelli
Roma, 168
Germany6 sites, 1 recruiting
- Recruiting
NeuroCure Clinical Research Center
Berlin, 10117
- Completed
Universitatsmedizin Gottingen
Göttingen, 37075
- Completed
Universitaetsklinikum Leipzig
Leipzig, 04103
- Completed
Universitatsklinikum Schleswig Holstein Campus Lubeck
Lübeck, 23538
- Completed
Universitatsklinikum Ulm
Ulm, 89081
- Completed
DKD HELIOS Klinik Wiesbaden, Fachbereich Neurologie
Wiesbaden, 65191
Belgium5 sites, 5 recruiting
- Recruiting
ULB Hôpital Erasme
Anderlecht, 1070
- Recruiting
AZ Sint Jan Brugge Oostende AV
Bruges, 8000
- Recruiting
Cliniques Universitaires Saint Luc
Brussels, 1200
- Recruiting
AZ Sint-Lucas
Ghent, 9000
- Recruiting
University Hospitals Leuven
Leuven, 3000
France5 sites, 3 recruiting
- Recruiting
Hopital Pierre Wertheimer
Bron, 69500
- Completed
CHU Grenoble
Grenoble, 38043
- Recruiting
Hopital de la Pitie Salpetriere
Paris, 75013
- Completed
Hopital Pasteur 1
Provence-Alpes-Côte d'Azur, 06000
- Recruiting
Hopital PASTEUR
Provence-Alpes-Côte d'Azur, 06000
Poland5 sites, 5 recruiting
- Recruiting
Neurocentrum Bydgoszcz Sp Z O O
Bydgoszcz, 85 796
- Recruiting
Neurologia Slaska Centrum Medyczne
Katowice, 40-689
- Recruiting
Centrum Neurologii Klinicznej Krakowska Akademia Neurologii
Krakow, 31 505
- Recruiting
Prywatny Gabinet Lekarski
Lublin, 20 093
- Recruiting
Centrum Medyczne NeuroProtect
Warsaw, 01-684
South Korea4 sites, 3 recruiting
- Recruiting
Pusan National University Hospital
Busan, 49241
- Recruiting
Kyungpook National University Chilgok Hospital
Daegu, 41404
- Completed
Kyungpook National University Hospital
Daegu, 41944
- Recruiting
Severance Hospital Yonsei University Health System
Seoul, 120-752
Canada3 sites, 2 recruiting
- Completed
McGill University
Montreal, Quebec, H3A 2B4
- Recruiting
The Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y 4E9
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Czechia3 sites, 2 recruiting
- Recruiting
Neurologie a rehabilitace Skopalíkova
Brno, 615 00
- Completed
Fakultni nemocnice Brno
Brno, 625 00
- Recruiting
Vseobecna Fakultní Nemocnice
Prague, 12808
Mexico3 sites, 2 recruiting
- Completed
iBiomed Research Unit
Aguascalientes, 20010
- Recruiting
Consultorio Dr. Miguel Cortes
Cuernavaca, 62448
- Recruiting
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, 44280
Taiwan3 sites, 2 recruiting
- Completed
China Medical University Hospital
Taichung, 40447
- Recruiting
Shin Kong Wu Ho Su Memorial Hospital
Taipei, 111
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Australia2 sites, 1 recruiting
- Completed
Melbourne Neurology Group
North Melbourne, 3051
- Recruiting
Gold Coast University Hospital
Southport, 4215
Denmark2 sites
- Completed
Aalborg University Hospital
Aalborg, 9000
- Completed
Rigshospitalet
København Ø, 2100
Sweden2 sites, 1 recruiting
- Completed
Karlstad Central Hospital
Karlstad, 651 85
- Recruiting
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76
About this study
Official title: 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.
- Conditions
- Myasthenia Gravis
- Being tested
- Nipocalimab, Placebo, Nipocalimab SC-LIV
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NipocalimabDrug
Also called JNJ-80202135, M281
Nipocalimab will be administered as an IV infusion.
PlaceboDrug
Matching placebo will be administered as an IV infusion.
Nipocalimab SC-LIVDrug
Nipocalimab will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nipocalimab |
| 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. Receives: Drug: Placebo |
| 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. Receives: Drug: Nipocalimab SC-LIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57)
Secondary outcomes (45)
DB Phase: Average Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score Over Weeks 22 and 24
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Weeks 22, 23, and 24
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: From start of treatment (DB phase Day 1) up to 4 years 9 months
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Measured: From start of treatment (DB phase Day 1) up to 4 years 9 months
Percentage of Participants With AEs of Special Interest (AESIs)
Measured: From start of treatment (DB phase Day 1) up to 4 years 9 months
Number of Participants With Change in Vital Signs
Measured: From start of treatment (DB phase Day 1) up to 4 years 9 months
Number of Participants With Change in Clinical Laboratory Values
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline up to Week 24
Serum Concentrations of Nipocalimab Over Time
Measured: 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])
Measured: From start of treatment (Day 1) up to 4 years 9 months
Percent Change From Baseline in Total Serum Immunoglobulin G (IgG) Concentrations
Measured: Baseline up to 4 years 9 months
Change From Baseline in Levels of Autoantibodies Associated With Generalized Myasthenia Gravis (gMG)
Measured: 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
Measured: Baseline up to 4 years 9 months
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score as a Function of Immunoglobulin G (IgG)
Measured: 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
Measured: 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
Measured: Baseline up to 4 years 9 months
Sub Study: Number of Participants With Treatment-Emergent AEs
Measured: Up to SC Week 8 (Day 57)
Sub Study: Number of Participants With Abnormalities in Vital Signs
Measured: Up to SC Week 8 (Day 57)
Sub Study: Number of Participants With Abnormalities in Physical Examinations
Measured: Up to SC Week 8 (Day 57)
Sub Study: Number of Participants With Abnormalities in Laboratory Parameters
Measured: Up to SC Week 8 (Day 57)
Sub Study: Numeric Pain Rating Scale (NPRS) Assessment With SC Use of Nipocalimab
Measured: Up to SC Week 8 (Day 57)
Sub Study: Number of Participants With Injection Site-Reactions
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start15 Jul 2021
- Primary completion17 Nov 2023
- Study completion29 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 199 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951622
- Sponsor's protocol ID
- CR109046
- Other IDs
- MOM-M281-011, 2020-005732-29, 2023-504152-97-00, 2023
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2021
- Last updated
- 27 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
- Expanded access
- Available
Publications
Claeys KG, Yang H, Gandhi K, Turkoz I, Fitzgibbon M, Pease S, Ramchandren S. Efficacy of nipocalimab in patients with moderate-to-severe ocular symptoms of generalized myasthenia gravis in the phase 3 Vivacity-MG3 study. Expert Opin Biol Ther. 2026 Aug 31. doi: 10.1080/14712598.2026.2725147. Online ahead of print.
PubMed 42675831Yu 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.
PubMed 42084498Antozzi 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.
PubMed 41021216Raborn 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.
PubMed 40515798Antozzi 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.
PubMed 39862879