Myasthenia GravisPhase 3EPICNCT07217587
Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis
A Phase 3 study testing Nipocalimab and Efgartigimod in people with Myasthenia Gravis, run by Janssen Research & Development, LLC at 31 sites in 5 countries.
Trial summary
The purpose of this study is to assess how well nipocalimab works when compared to efgartigimod in participants with generalized myasthenia gravis (a condition in which body's immune system mistakenly attacks and damages the connection between nerves and muscles causing muscle weakness). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- Nipocalimab and Efgartigimod
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 31 sitesin 5 countries
- Study dates
- 5 Jan 2026to 29 Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For all arms:
- Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening
- Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized MG (gMG) as defined by the Myasthenia gravis foundation of America (MGFA) clinical classification class II a/b, III a/b, or IV a/b at screening and positive for acetylcholine receptor (AChR) antibodies
- Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of greater than or equal to (>=) 5 with less than (<) 50% of symptoms coming from ocular MG-ADL sub-scores at study screening and baseline (Day 1) visits
- Criteria specific to Arms 1 and 2 only:
- Has suboptimal response to current stable therapy for gMG according to the investigator or has discontinued corticosteroids and/or immunosuppressants/immunomodulators including eculizumab or other novel approved immune agents at least 4 weeks prior to baseline due to intolerance or lack of efficacy
- Criteria specific to Arm 3:
- Treatment with efgartigimod IV or subcutaneous (SC) for >=1 cycle, and the final cycle is consistent with product information
Who cannot join
- 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
- Had a thymectomy within 1 year prior to baseline, or thymectomy is planned during the study
- Currently has a malignancy or has a history of malignancy within 3 years before baseline
- Criteria specific to Arms 1 and 2 only:
- Has received treatment for MG with an FcRn-targeting therapy
- Criteria specific to Arm 3 only:
- Is currently taking IgG monoclonal antibody therapeutics, or Fc-conjugated therapeutic agents, including factor or enzyme replacement, with the exception of efgartigimod
Trial locations and contacts
31 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
31 sites in 5 countries
United States20 sites, 19 recruiting
- Recruiting
Austin Neuromuscular Center
Austin, Texas, 78759
- Recruiting
SFM Clinical Research LLC
Boca Raton, Florida, 33487
- Recruiting
Research of the Rockies LLC
Colorado Springs, Colorado, 80919
- Recruiting
Neurology Clinic, PC
Cordova, Tennessee, 38018
- Recruiting
Texas Neurology
Dallas, Texas, 75206
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
- Recruiting
Michigan State University
East Lansing, Michigan, 48823
- Recruiting
University of Connecticut
Farmington, Connecticut, 06030
- Completed
Advanced Neurology of Colorado
Fort Collins, Colorado, 80528
- Recruiting
Neurology Center Of New England PC
Foxborough, Massachusetts, 02035
- Recruiting
Neurology Center of North Orange County
Fullerton, California, 92835
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77054
- Recruiting
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, 46256
- Recruiting
EvergreenHealth Neurology
Kirkland, Washington, 98034
- Recruiting
Tulane Center for Clinical Research
New Orleans, Louisiana, 70112
- Recruiting
Equity Medical
New York, New York, 10023
- Recruiting
HSHS St. Elizabeth's Hospital
O'Fallon, Illinois, 62269
- Recruiting
The Neurology Group
Pomona, California, 91767
- Recruiting
Velocity Clinical Research, Inc.
Raleigh, North Carolina, 27607 6010
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Spain5 sites, 5 recruiting
- Recruiting
Hosp. Clinic de Barcelona
Barcelona, 08036
- Recruiting
Hosp. Univ. Ramon Y Cajal
Madrid, 28034
- Recruiting
Hosp. Univ. Infanta Sofia
Madrid, 28702
- Recruiting
Hosp. Virgen Macarena
Seville, 41009
- Recruiting
Hosp. Clinico Univ. de Valencia
Valencia, 46010
Germany3 sites, 3 recruiting
- Recruiting
Klinikum Altenburger Land GmbH
Altenburg, 04600
- Recruiting
Katholisches Klinikum Bochum gGmbH
Bochum, 44791
- Recruiting
Universitatsklinikum Freiburg
Freiburg im Breisgau, 79106
Israel2 sites, 2 recruiting
- Recruiting
Rambam Medical Center
Haifa, 3109601
- Recruiting
Sourasky Medical Center
Tel Aviv, 6423906
Switzerland1 site, 1 recruiting
- Recruiting
HOCH Health Ostschweiz Kantonsspital St.Gallen
Sankt Gallen, 9007
About this study
Official title: Efficacy and Safety of Nipocalimab vs Efgartigimod for Patients With Generalized Myasthenia Gravis in a Randomized, Open-label, Phase 3b, Interventional Trial Including Within Class Switching From Efgartigimod to Nipocalimab
The purpose of this study is to assess how well nipocalimab works when compared to efgartigimod in participants with generalized myasthenia gravis (a condition in which body's immune system mistakenly attacks and damages the connection between nerves and muscles causing muscle weakness).
- Conditions
- Myasthenia Gravis
- Being tested
- Nipocalimab, Efgartigimod
- 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, JNJ-86507083
Nipocalimab will be administered intravenously.
EfgartigimodDrug
Efgartigimod will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Nipocalimab | Experimental | Participants will receive nipocalimab intravenously (IV), at a loading dose on Day 1 followed by maintenance dosing once every 2 weeks (q2w) until Week 12. Receives: Drug: Nipocalimab |
| Arm 2: Efgartigimod | Active comparator | Participants will receive efgartigimod IV, once a week for 4 weeks starting from Day 1. Eligible participants will be given the option to switch to Arm 3 between Week 4 and Week 12. Receives: Drug: Efgartigimod |
| Arm 3: Treatment Switch (Nipocalimab) | Experimental | Participants previously treated with efgartigimod, who are directly enrolled in this arm, and eligible participants switching from Arm 2 will receive nipocalimab IV at a loading dose on Switch Day 1 followed by maintenance dosing q2w until Switch Week 12. Receives: Drug: Nipocalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arms 1 and 2: Averaged Mean Percent Change from Baseline in Total Immunoglobulin G (IgG) Levels Over Weeks 8, 10 and 12
Average mean percent change from baseline in total IgG levels over Weeks 8 , 10 and 12 will be reported.
Measured: Baseline, Weeks 8, 10 and 12
Secondary outcomes (20)
Arms 1 and 2: Averaged Mean Change from Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score Over Weeks 8, 10 and 12
Average mean change from baseline in MG-ADL total score over Weeks 8, 10 and 12 will be reported. The MG-ADL provides a rapid assessment of the participant's MG symptom severity. Eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, eyelid droop) are rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score will be sum of eight function scores and can range from 0 to 24. A higher score indicates greater symptom severity.
Measured: Baseline, Weeks 8, 10 and 12
Arms 1 and 2: Mean Percent Change from Baseline in Total IgG Between Arm 1 at EoT and Arm 2 at EoC Based on Clinical Evaluation
Mean percent change from baseline in total IgG between Arm 1 at end of treatment (EoT) and Arm 2 at end of cycle (EoC) based on clinical evaluation will be reported. EoC based on clinical evaluation is defined as the timepoint at which after completion of one cycle of efgartigimod, based on MG-ADL score clinical criteria, the treatment decision would be made to start a second cycle of efgartigimod, an MG rescue medication, or Week 12/EoT, whichever occurs first.
Measured: Baseline, EoT (for Arm 1) and EoC (Arm 2) up to Week 12
Arms 1 and 2: Mean Percent Change from Baseline in MG-ADL Total Score Between Arm 1 at EoT and Arm 2 at EoC Based on Clinical Evaluation
Mean change from baseline in MG-ADL total score between Arm 1 at EoT and Arm 2 at EoC based on clinical evaluation will be reported. MG-ADL provides a rapid assessment of the participant's MG symptom severity. The total score can range from 0 to 24. A higher score indicates greater symptom severity.
Measured: Baseline, EoT (for Arm 1) and EoC (Arm 2) up to Week 12
Arms 1 and 2: Mean Percent Change from Baseline in Total IgG Levels at Week 8
Mean percent change from baseline in total IgG levels at Week 8 will be reported.
Measured: Baseline and Week 8
Arms 1 and 2: Mean Change from Baseline in MG-ADL Total Score at Week 8
Mean change from baseline in MG-ADL total score at Week 8 will be reported. MG-ADL provides a rapid assessment of the participant's MG symptom severity. The total score can range from 0 to 24. A higher score indicates greater symptom severity.
Measured: Baseline and Week 8
Arms 1 and 2: Averaged Mean Change from Baseline in Quantitative Myasthenia Gravis (QMG) Total Score Over Weeks 8 and 12
Average mean change from baseline in QMG total score over Weeks 8 and 12 will be reported. The QMG test is a standardized quantitative strength assessment comprising 13 components. The quantitative results of each strength component are mapped to the following 4-point scale: 0 = None, 1 = Mild, 2 = Moderate and 3 = Severe. The total score can range from 0 to 39. A higher score indicates greater weakness.
Measured: Baseline, Weeks 8 and 12
Arms 1 and 2: Mean Percent Change from Baseline in QMG Total Score Between Arm 1 at EoT and Arm 2 at EoC Based on Clinical Evaluation
Mean change from baseline in QMG total score between Arm 1 at EoT and Arm 2 at EoC based on clinical evaluation will be reported. The QMG test is a standardized quantitative strength assessment comprising 13 components. The quantitative results of each strength component are mapped to the following 4-point scale: 0 = None, 1 = Mild, 2 = Moderate and 3 = Severe. The total score can range from 0 to 39. A higher score indicates greater weakness.
Measured: Baseline, EoT (for Arm 1) and EoC (Arm 2) up to Week 12
Arms 1 and 2: Mean Change from Baseline in QMG Total Score at Week 8
Mean change from baseline in QMG total score at Week 8 will be reported.
Measured: Baseline and Week 8
Arms 1 and 2: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for At Least 6 Weeks During Randomized Treatment Phase
Percentage of participants maintaining >= 2-point improvement in MG-ADL total score for at least 6 weeks during the 12 week randomized treatment phase between Arms 1 and 2 will be reported. MG-ADL provides a rapid assessment of the participant's MG symptom severity. The total score can range from 0 to 24. A higher score indicates greater symptom severity.
Measured: Baseline up to Week 12
Arms 1 and 2: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for At Least 8 Weeks During Randomized Treatment Phase
Percentage of participants maintaining >= 2-point improvement in MG-ADL total score for at least 8 weeks during the 12 week randomized treatment phase between Arms 1 and 2 will be reported. MG-ADL provides a rapid assessment of the participant's MG symptom severity. The total score can range from 0 to 24. A higher score indicates greater symptom severity.
Measured: Baseline up to Week 12
Arms 1 and 2: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for 50% of Postbaseline Observations
Percentage of participants maintaining >= 2-point improvement in MG-ADL total score for at least 50% of study duration between Arms 1 and 2 will be reported. MG-ADL provides a rapid assessment of the participant's MG symptom severity. The total score can range from 0 to 24. A higher score indicates greater symptom severity.
Measured: Baseline, Week 2 up to Week 12
Arms 1 and 2: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for 75% of Postbaseline Observations
Percentage of participants maintaining >= 2-point improvement in MG-ADL for at least 75% of study duration between Arms 1 and 2 will be reported.
Measured: Baseline, Week 2 up to Week 12
Arms 1 and 2: Percentage of Participants with MG-ADL Total Score of 0 or 1 at Week 12
Percentage of participants with MG-ADL total score of 0 or 1 at end of study treatment between Arms 1 and 2 will be reported. MG-ADL provides a rapid assessment of the participant's MG symptom severity. The total score can range from 0 to 24. A higher score indicates greater symptom severity.
Measured: Week 12
Arm 3: Mean Percent Change in Total IgG from Switch Day 1 to Switch Week 12
Mean percent change in total IgG from pre-nipocalimab exposure to end of nipocalimab study treatment in Arm 3 will be reported.
Measured: Switch Day 1 to Switch Week 12
Arm 3: Mean Change in MG-ADL Total Score from Switch Day 1 to Switch Week 12
Mean change in MG-ADL total score from pre-nipocalimab exposure to end of nipocalimab study treatment in Arm 3 will be reported. MG-ADL provides a rapid assessment of the participant's MG symptom severity. The total score can range from 0 to 24. A higher score indicates greater symptom severity.
Measured: Switch Day 1 to Switch Week 12
Arm 3: Percentage of Participants with >= 2-Point Improvement in MG-ADL Total Score at Switch Week 12
Percentage of participants with >= 2-point improvement in MG-ADL total score at switch week 12 in Arm 3 will be reported.
Measured: At Switch Week 12
Arm 3: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for At Least 6 Weeks During Treatment Phase
Percentage of participants maintaining >= 2-point improvement in MG-ADL total score while on nipocalimab for at least 6 weeks during treatment phase in Arm 3 will be reported. MG-ADL provides a rapid assessment of the participant's MG symptom severity. The total score can range from 0 to 24. A higher score indicates greater symptom severity.
Measured: Switch Day 1 up to Switch Week 12
Arm 3: Percentage of Participants with MG-ADL Total Score of 0 or 1 at Switch Week 12
Percentage of participants with MG-ADL total score of 0 or 1 at switch week 12 in Arm 3 will be reported. MG-ADL provides a rapid assessment of the participant's MG symptom severity. The total score can range from 0 to 24. A higher score indicates greater symptom severity.
Measured: At Switch Week 12
Arms 1 and 2: Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
An AE is any untoward medical occurrence in a clinical study participant administered with a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important. Treatment-emergent AEs associated with a. infections that are severe or require IV anti-infective or operative/invasive intervention, b. events of hypoalbuminemia <20 g/L and c. serious and non-serious venous thromboembolism (VTE; deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) will be considered AESIs.
Measured: Up to Week 20
Arm 3: Number of Participants with AEs, SAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant administered with a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important. Treatment-emergent AEs associated with a. infections that are severe or require IV anti-infective or operative/invasive intervention, b. events of hypoalbuminemia <20 g/L and c. serious and non-serious venous thromboembolism (VTE; DVT and/or PE) will be considered AESIs.
Measured: Up to Switch Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2025
- Study start5 Jan 2026
- Primary completion28 Sep 2027 (estimated)
- Study completion29 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 115 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
- NCT07217587
- Sponsor's protocol ID
- 80202135MYG3002
- Other IDs
- 80202135MYG3002, 2025-521130-28-00, 2025
- Acronym
- EPIC
- Status last verified
- Nov 2026
- First submitted
- 15 Oct 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Nipocalimab vs Efgartigimod for Patients With Generalized Myasthenia Gravis in a Randomized, Open-label, Phase 3b, Interventional Trial Including Within Class Switching From Efgartigimod to Nipocalimab
- ClinicalTrials.gov ID
- NCT07217587
- Acronym / sponsor ID
- EPIC / 80202135MYG3002
- Conditions
- Myasthenia Gravis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 28 Sep 2027 (estimated)
- Study completion
- 29 Jan 2029 (estimated)
- First posted
- 16 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess how well nipocalimab works when compared to efgartigimod in participants with generalized myasthenia gravis (a condition in which body's immune system mistakenly attacks and damages the connection between nerves and muscles causing muscle weakness).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Nipocalimab | Experimental | Drug: NipocalimabParticipants will receive nipocalimab intravenously (IV), at a loading dose on Day 1 followed by maintenance dosing once every 2 weeks (q2w) until Week 12. |
| Arm 2: Efgartigimod | Active comparator | Drug: EfgartigimodParticipants will receive efgartigimod IV, once a week for 4 weeks starting from Day 1. Eligible participants will be given the option to switch to Arm 3 between Week 4 and Week 12. |
| Arm 3: Treatment Switch (Nipocalimab) | Experimental | Drug: NipocalimabParticipants previously treated with efgartigimod, who are directly enrolled in this arm, and eligible participants switching from Arm 2 will receive nipocalimab IV at a loading dose on Switch Day 1 followed by maintenance dosing q2w until Switch Week 12. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening
- Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized MG (gMG) as defined by the Myasthenia gravis foundation of America (MGFA) clinical classification class II a/b, III a/b, or IV a/b at screening and positive for acetylcholine receptor (AChR) antibodies
- Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of greater than or equal to (>=) 5 with less than (<) 50% of symptoms coming from ocular MG-ADL sub-scores at study screening and baseline (Day 1) visits
- Has suboptimal response to current stable therapy for gMG according to the investigator or has discontinued corticosteroids and/or immunosuppressants/immunomodulators including eculizumab or other novel approved immune agents at least 4 weeks prior to baseline due to intolerance or lack of efficacy
- Treatment with efgartigimod IV or subcutaneous (SC) for >=1 cycle, and the final cycle is consistent with product information
Key exclusion criteria (7 listed)
- 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
- Had a thymectomy within 1 year prior to baseline, or thymectomy is planned during the study
- Currently has a malignancy or has a history of malignancy within 3 years before baseline
- Has received treatment for MG with an FcRn-targeting therapy
- Is currently taking IgG monoclonal antibody therapeutics, or Fc-conjugated therapeutic agents, including factor or enzyme replacement, with the exception of efgartigimod
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NipocalimabAlso: JNJ-80202135, JNJ-86507083Nipocalimab will be administered intravenously. | Drug | Arm 1: Nipocalimab, Arm 3: Treatment Switch (Nipocalimab) |
| EfgartigimodEfgartigimod will be administered intravenously. | Drug | Arm 2: Efgartigimod |
Primary outcome
Arms 1 and 2: Averaged Mean Percent Change from Baseline in Total Immunoglobulin G (IgG) Levels Over Weeks 8, 10 and 12
Time frame: Baseline, Weeks 8, 10 and 12
Average mean percent change from baseline in total IgG levels over Weeks 8 , 10 and 12 will be reported.
20 secondary outcomes
Arms 1 and 2: Averaged Mean Change from Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score Over Weeks 8, 10 and 12
Time frame: Baseline, Weeks 8, 10 and 12
Arms 1 and 2: Mean Percent Change from Baseline in Total IgG Between Arm 1 at EoT and Arm 2 at EoC Based on Clinical Evaluation
Time frame: Baseline, EoT (for Arm 1) and EoC (Arm 2) up to Week 12
Arms 1 and 2: Mean Percent Change from Baseline in MG-ADL Total Score Between Arm 1 at EoT and Arm 2 at EoC Based on Clinical Evaluation
Time frame: Baseline, EoT (for Arm 1) and EoC (Arm 2) up to Week 12
Arms 1 and 2: Mean Percent Change from Baseline in Total IgG Levels at Week 8
Time frame: Baseline and Week 8
Arms 1 and 2: Mean Change from Baseline in MG-ADL Total Score at Week 8
Time frame: Baseline and Week 8
Arms 1 and 2: Averaged Mean Change from Baseline in Quantitative Myasthenia Gravis (QMG) Total Score Over Weeks 8 and 12
Time frame: Baseline, Weeks 8 and 12
Arms 1 and 2: Mean Percent Change from Baseline in QMG Total Score Between Arm 1 at EoT and Arm 2 at EoC Based on Clinical Evaluation
Time frame: Baseline, EoT (for Arm 1) and EoC (Arm 2) up to Week 12
Arms 1 and 2: Mean Change from Baseline in QMG Total Score at Week 8
Time frame: Baseline and Week 8
Arms 1 and 2: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for At Least 6 Weeks During Randomized Treatment Phase
Time frame: Baseline up to Week 12
Arms 1 and 2: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for At Least 8 Weeks During Randomized Treatment Phase
Time frame: Baseline up to Week 12
Arms 1 and 2: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for 50% of Postbaseline Observations
Time frame: Baseline, Week 2 up to Week 12
Arms 1 and 2: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for 75% of Postbaseline Observations
Time frame: Baseline, Week 2 up to Week 12
Arms 1 and 2: Percentage of Participants with MG-ADL Total Score of 0 or 1 at Week 12
Time frame: Week 12
Arm 3: Mean Percent Change in Total IgG from Switch Day 1 to Switch Week 12
Time frame: Switch Day 1 to Switch Week 12
Arm 3: Mean Change in MG-ADL Total Score from Switch Day 1 to Switch Week 12
Time frame: Switch Day 1 to Switch Week 12
Arm 3: Percentage of Participants with >= 2-Point Improvement in MG-ADL Total Score at Switch Week 12
Time frame: At Switch Week 12
Arm 3: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for At Least 6 Weeks During Treatment Phase
Time frame: Switch Day 1 up to Switch Week 12
Arm 3: Percentage of Participants with MG-ADL Total Score of 0 or 1 at Switch Week 12
Time frame: At Switch Week 12
Arms 1 and 2: Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Time frame: Up to Week 20
Arm 3: Number of Participants with AEs, SAEs and AESIs
Time frame: Up to Switch Week 20
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
31 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nipocalimab and Efgartigimod in people with Myasthenia Gravis, run by Janssen Research & Development, LLC at 31 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Spain, Germany, Israel, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arms 1 and 2: Averaged Mean Percent Change from Baseline in Total Immunoglobulin G (IgG) Levels Over Weeks 8, 10 and 12 (time frame: Baseline, Weeks 8, 10 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.