Trial Outcomes & Findings for An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis (NCT NCT04980495)
NCT ID: NCT04980495
Last Updated: 2026-05-27
Results Overview
The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
69 participants
Primary outcome timeframe
Up to 21 weeks
Results posted on
2026-05-27
Participant Flow
The study was conducted at 31 sites that enrolled participants with anti-acetylcholine receptor antibody (AChR-Ab) seropositive gMG in 11 countries. A total of 98 participants were screened of whom 69 were randomized and treated. The results presented are based on the primary completion date. Remaining results will be reported within a year of global study completion.
Participant milestones
| Measure |
Efgartigimod IV - Continuous Regimen
Participants receiving efgartigimod IV on a continuous regimen. The continuous dosing regimen consisted of 4 once-weekly intravenous administrations followed by once-every-other-week administration.
|
Efgartigimod IV - Cyclic Regimen
Participants receiving efgartigimod IV on a cyclic regimen. The cyclic dosing regimen consisted of 3 cycles of 4 once-weekly intravenous administrations followed by a fixed 4-week intertreatment period.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
17
|
|
Overall Study
Completed Part A
|
50
|
15
|
|
Overall Study
COMPLETED
|
35
|
11
|
|
Overall Study
NOT COMPLETED
|
17
|
6
|
Reasons for withdrawal
| Measure |
Efgartigimod IV - Continuous Regimen
Participants receiving efgartigimod IV on a continuous regimen. The continuous dosing regimen consisted of 4 once-weekly intravenous administrations followed by once-every-other-week administration.
|
Efgartigimod IV - Cyclic Regimen
Participants receiving efgartigimod IV on a cyclic regimen. The cyclic dosing regimen consisted of 3 cycles of 4 once-weekly intravenous administrations followed by a fixed 4-week intertreatment period.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Requires prohibited medication
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
|
Overall Study
Other reasons
|
2
|
0
|
Baseline Characteristics
An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis
Baseline characteristics by cohort
| Measure |
Efgartigimod IV - Cyclic Regimen
n=17 Participants
Participants receiving efgartigimod IV on a cyclic regimen. The cyclic dosing regimen consisted of 3 cycles of 4 once-weekly intravenous administrations followed by a fixed 4-week intertreatment period.
|
Efgartigimod IV - Continuous Regimen
n=52 Participants
Participants receiving efgartigimod IV on a continuous regimen. The continuous dosing regimen consisted of 4 once-weekly intravenous administrations followed by once-every-other-week administration.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
17 Participants
n=51 Participants
|
50 Participants
n=14 Participants
|
67 Participants
n=65 Participants
|
|
Age, Continuous
|
52.4 Age (years)
STANDARD_DEVIATION 16.10 • n=51 Participants
|
57.1 Age (years)
STANDARD_DEVIATION 16.49 • n=14 Participants
|
55.9 Age (years)
STANDARD_DEVIATION 16.40 • n=65 Participants
|
|
Age, Customized
Age, category · 18 - 64 years
|
12 Participants
n=51 Participants
|
32 Participants
n=14 Participants
|
44 Participants
n=65 Participants
|
|
Age, Customized
Age, category · >= 65 years
|
5 Participants
n=51 Participants
|
20 Participants
n=14 Participants
|
25 Participants
n=65 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=51 Participants
|
34 Participants
n=14 Participants
|
43 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=51 Participants
|
18 Participants
n=14 Participants
|
26 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
2 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
2 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
14 Participants
n=51 Participants
|
50 Participants
n=14 Participants
|
64 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
0 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
0 Participants
n=51 Participants
|
2 Participants
n=14 Participants
|
2 Participants
n=65 Participants
|
PRIMARY outcome
Timeframe: Up to 21 weeksPopulation: mITT (modified intent-to-treat) analysis set: all randomized participants with an MG-ADL total score at baseline and at least 1 postbaseline analysis visit at or before week 21.
The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.
Outcome measures
| Measure |
Efgartigimod IV - Cyclic Regimen
n=17 Participants
Participants receiving efgartigimod IV on a cyclic regimen. The cyclic dosing regimen consisted of 3 cycles of 4 once-weekly intravenous administrations followed by a fixed 4-week intertreatment period.
|
Efgartigimod IV - Continuous Regimen
n=52 Participants
Participants receiving efgartigimod IV on a continuous regimen. The continuous dosing regimen consisted of 4 once-weekly intravenous administrations followed by once-every-other-week administration.
|
|---|---|---|
|
Mean of the Average MG-ADL Total Score Change From Baseline During the Visit of Week 1 Through Week 21 by Regimen Arm
|
-5.13 Score on a scale
Interval -6.499 to -3.767
|
-4.61 Score on a scale
Interval -5.383 to -3.845
|
SECONDARY outcome
Timeframe: Up to 135 weeksAE : adverse event; SAE: serious adverse event; AESI: adverse event of special interest
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 126 weeksThe MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 21 weeksThe MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 21 weeksThe MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 21 weeksThe MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From week 4 to week 21The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 21 weeksMSE = minimal symptom expression; The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.
Outcome measures
Outcome data not reported
Adverse Events
Efgartigimod IV - Cyclic Regimen
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Efgartigimod IV - Continuous Regimen
Serious events: 7 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Efgartigimod IV - Cyclic Regimen
n=17 participants at risk
Participants receiving efgartigimod IV on a cyclic regimen. The cyclic dosing regimen consisted of 3 cycles of 4 once-weekly intravenous administrations followed by a fixed 4-week intertreatment period.
|
Efgartigimod IV - Continuous Regimen
n=52 participants at risk
Participants receiving efgartigimod IV on a continuous regimen. The continuous dosing regimen consisted of 4 once-weekly intravenous administrations followed by once-every-other-week administration.
|
|---|---|---|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
1.9%
1/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Infections and infestations
COVID-19
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
1.9%
1/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Nervous system disorders
MYASTHENIA GRAVIS
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
3.8%
2/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Nervous system disorders
MYASTHENIA GRAVIS CRISIS
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
1.9%
1/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
1.9%
1/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS
|
0.00%
0/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
1.9%
1/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
Other adverse events
| Measure |
Efgartigimod IV - Cyclic Regimen
n=17 participants at risk
Participants receiving efgartigimod IV on a cyclic regimen. The cyclic dosing regimen consisted of 3 cycles of 4 once-weekly intravenous administrations followed by a fixed 4-week intertreatment period.
|
Efgartigimod IV - Continuous Regimen
n=52 participants at risk
Participants receiving efgartigimod IV on a continuous regimen. The continuous dosing regimen consisted of 4 once-weekly intravenous administrations followed by once-every-other-week administration.
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
3.8%
2/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
1.9%
1/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Gastrointestinal disorders
DIARRHOEA
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
9.6%
5/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Gastrointestinal disorders
NAUSEA
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
9.6%
5/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Gastrointestinal disorders
VOMITING
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
3.8%
2/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
General disorders
FATIGUE
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
3.8%
2/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
General disorders
PYREXIA
|
0.00%
0/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
9.6%
5/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Infections and infestations
BRONCHITIS
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
9.6%
5/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Infections and infestations
COVID-19
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
21.2%
11/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Infections and infestations
HERPES ZOSTER
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Infections and infestations
INFLUENZA
|
11.8%
2/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
5.8%
3/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Infections and infestations
NASOPHARYNGITIS
|
11.8%
2/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
1.9%
1/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
11.8%
2/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
9.6%
5/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
7.7%
4/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Injury, poisoning and procedural complications
FALL
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
1.9%
1/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Investigations
FIBRIN D DIMER INCREASED
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
11.8%
2/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
3.8%
2/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
11.8%
2/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
1.9%
1/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
3.8%
2/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
11.8%
2/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
3.8%
2/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Nervous system disorders
DIZZINESS
|
11.8%
2/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
1.9%
1/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Nervous system disorders
HEADACHE
|
29.4%
5/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
15.4%
8/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Nervous system disorders
MYASTHENIA GRAVIS
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
1.9%
1/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Psychiatric disorders
INSOMNIA
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
3.8%
2/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
3.8%
2/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
1.9%
1/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Skin and subcutaneous tissue disorders
RASH
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
5.8%
3/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Ear and labyrinth disorders
VERTIGO
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Eye disorders
CYSTOID MACULAR OEDEMA
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Eye disorders
DRY EYE
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Eye disorders
VISUAL IMPAIRMENT
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Gastrointestinal disorders
MELAENA
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
General disorders
ADMINISTRATION SITE EXTRAVASATION
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Immune system disorders
SEASONAL ALLERGY
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
1.9%
1/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Infections and infestations
CONJUNCTIVITIS
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
3.8%
2/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Infections and infestations
EYE INFECTION
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Infections and infestations
HERPES VIRUS INFECTION
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
1.9%
1/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
5.8%
3/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
11.8%
2/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Investigations
WEIGHT INCREASED
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
1.9%
1/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
11.8%
2/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
1.9%
1/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Nervous system disorders
MIGRAINE
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Nervous system disorders
SCIATICA
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Nervous system disorders
SOMNOLENCE
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
1.9%
1/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Nervous system disorders
SPEECH DISORDER
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Psychiatric disorders
ANXIETY
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Psychiatric disorders
DEPRESSION
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Renal and urinary disorders
GLYCOSURIA
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
LOWER RESPIRATORY TRACT INFLAMMATION
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY TRACT INFLAMMATION
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Skin and subcutaneous tissue disorders
MACULE
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
1.9%
1/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Vascular disorders
HOT FLUSH
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
|
Infections and infestations
TONSILITIS
|
5.9%
1/17 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
0.00%
0/52 • Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place