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

Secondary

• 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