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| ID | Type | Description | Link |
|---|---|---|---|
| 80202135MYG3002 | Other Identifier | Janssen Research & Development, LLC | |
| 2025-521130-28-00 | Registry Identifier | EUCT number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nipocalimab | Drug | Nipocalimab will be administered intravenously. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Weeks 8, 10 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
For all arms:
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
Exclusion criteria:
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
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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 |
|---|---|---|---|---|---|---|
| Neurology Center of North Orange County | Recruiting | Fullerton | California | 92835 | United States | |
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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| Efgartigimod | Drug | Efgartigimod will be administered intravenously. |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to Switch Week 20 |
| The Neurology Group |
| Recruiting |
| Pomona |
| California |
| 91767 |
| United States |
| Advanced Neurology of Colorado | Recruiting | Fort Collins | Colorado | 80528 | United States |
| University of Connecticut | Recruiting | Farmington | Connecticut | 06030 | United States |
| SFM Clinical Research LLC | Recruiting | Boca Raton | Florida | 33487 | United States |
| HSHS St. Elizabeth's Hospital | Recruiting | O'Fallon | Illinois | 62269 | United States |
| Josephson Wallack Munshower Neurology, PC | Recruiting | Indianapolis | Indiana | 46256 | United States |
| Tulane Center for Clinical Research | Recruiting | New Orleans | Louisiana | 70112 | United States |
| Henry Ford Hospital | Recruiting | Detroit | Michigan | 48202 | United States |
| Velocity Clinical Research, Inc. | Recruiting | Raleigh | North Carolina | 27607 6010 | United States |
| Atrium Health Wake Forest Baptist | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
| Texas Neurology | Recruiting | Dallas | Texas | 75206 | United States |
| Rambam Medical Center | Recruiting | Haifa | 3109601 | Israel |
| Sourasky Medical Center | Recruiting | Tel Aviv | 6423906 | Israel |
| HOCH Health Ostschweiz Kantonsspital St.Gallen | Recruiting | Sankt Gallen | 9007 | Switzerland |
| 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 |
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| ID | Term |
|---|---|
| C000718373 | efgartigimod alfa |
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