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).

Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis

Autoantibody disorders (affecting the nervous system)

Brain and Nervous System Conditions

Nipocalimab

Efgartigimod

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

Average mean percent change from baseline in total IgG levels over Weeks 8 , 10 and 12 will be reported.

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.

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.

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.

Mean percent change from baseline in total IgG levels at Week 8 will be reported.

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.

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.

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.

Mean change from baseline in QMG total score at Week 8 will be reported.

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.

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.

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.

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.

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.

Mean percent change in total IgG from pre-nipocalimab exposure to end of nipocalimab study treatment in Arm 3 will be reported.

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.

Percentage of participants with >= 2-point improvement in MG-ADL total score at switch week 12 in Arm 3 will be reported.

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.

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.

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.

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.

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.

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.

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.

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).

Efficacy and Safety of Nipocalimab vs Efgartigimod in a Randomized, Open-label, Phase 3b, Interventional Trial Including Within Class Switching From Efgartigimod to Nipocalimab

Average mean percent change from baseline in total IgG levels over Weeks 8 , 10 and 12
will be reported.

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.

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.

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.

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.

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.

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.

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.

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.

Mean percent change in total IgG from pre-nipocalimab exposure to end of nipocalimab
study treatment in Arm 3 will be reported.

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.

Percentage of participants with >= 2-point improvement in MG-ADL total score at switch
week 12 in Arm 3 will be reported.

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.

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.

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.

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.

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.

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 8 and Week
12.

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.

Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis

Trials at a glance

Trials at a glance