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Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis
Myasthenia Gravis
Clinicaltrials.gov:
EU CTIS:
#2025-521130-28-00
Other:
#80202135MYG3002
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Trials at a glance
Status
Enrolling
Condition
Myasthenia Gravis
Trial type
Interventional
Trial phase
Phase 3
Investigational
product
product
Efgartigimod
Nipocalimab
Age
18 to 74 years old
Biological sex
All
Placebo?
No
Trial start date
January 5, 2026
Trial end date
December 11, 2028
CT.gov ID
#NCT07217587
Share the trial ID with your doctor to see if trial participation is right for you. Participation depends on an independent medical assessment.
Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis
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).
Primary outcome measures
- Arms 1 and 2: Averaged Mean Percent Change from Baseline in Total Immunoglobulin G (IgG) Levels Over Weeks 8, 10 and 12
Secondary outcome measures
- 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
- 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
- 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
- Arms 1 and 2: Mean Percent Change from Baseline in Total IgG Levels at Week 8
- Arms 1 and 2: Mean Change from Baseline in MG-ADL Total Score at Week 8
- Arms 1 and 2: Averaged Mean Change from Baseline in Quantitative Myasthenia Gravis (QMG) Total Score Over 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
- Arms 1 and 2: Mean Change from Baseline in QMG Total Score at 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
- 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
- Arms 1 and 2: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for 50% of Postbaseline Observations
- Arms 1 and 2: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for 75% of Postbaseline Observations
- Arms 1 and 2: Percentage of Participants with MG-ADL Total Score of 0 or 1 at Week 12
- Arm 3: Mean Percent Change in Total IgG from Switch Day 1 to Switch Week 12
- Arm 3: Mean Change in MG-ADL Total Score from 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
- Arm 3: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for At Least 6 Weeks During Treatment Phase
- Arm 3: Percentage of Participants with MG-ADL Total Score of 0 or 1 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)
- Arm 3: Number of Participants with AEs, SAEs and AESIs
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