Trial Outcomes & Findings for A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy (NCT NCT05225675)
NCT ID: NCT05225675
Last Updated: 2026-05-08
Results Overview
AE : Adverse Events, SAE: Serious Adverse Events
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Up to 80 weeks
Results posted on
2026-05-08
Participant Flow
Participant milestones
| Measure |
ARGX-117 Cohort 1
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
9
|
18
|
9
|
|
Overall Study
COMPLETED
|
17
|
8
|
18
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
ARGX-117 Cohort 1
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy
Baseline characteristics by cohort
| Measure |
ARGX-117 Cohort 1
n=18 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=9 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 Participants
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
n=9 Participants
Participants received placebo via IV infusion
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=41 Participants
|
7 Participants
n=40 Participants
|
16 Participants
n=81 Participants
|
7 Participants
n=140 Participants
|
46 Participants
n=451 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=41 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=81 Participants
|
2 Participants
n=140 Participants
|
8 Participants
n=451 Participants
|
|
Age, Continuous
|
54.5 years
n=41 Participants
|
44.0 years
n=40 Participants
|
55.5 years
n=81 Participants
|
58.0 years
n=140 Participants
|
55.0 years
n=451 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=41 Participants
|
4 Participants
n=40 Participants
|
6 Participants
n=81 Participants
|
4 Participants
n=140 Participants
|
21 Participants
n=451 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=41 Participants
|
5 Participants
n=40 Participants
|
12 Participants
n=81 Participants
|
5 Participants
n=140 Participants
|
33 Participants
n=451 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=41 Participants
|
7 Participants
n=40 Participants
|
17 Participants
n=81 Participants
|
8 Participants
n=140 Participants
|
49 Participants
n=451 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=81 Participants
|
2 Participants
n=140 Participants
|
4 Participants
n=451 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=41 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=140 Participants
|
2 Participants
n=451 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=81 Participants
|
0 Participants
n=140 Participants
|
1 Participants
n=451 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
17 Participants
n=41 Participants
|
8 Participants
n=40 Participants
|
16 Participants
n=81 Participants
|
7 Participants
n=140 Participants
|
48 Participants
n=451 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=41 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=140 Participants
|
1 Participants
n=451 Participants
|
PRIMARY outcome
Timeframe: Up to 80 weeksAE : Adverse Events, SAE: Serious Adverse Events
Outcome measures
| Measure |
ARGX-117 Cohort 1
n=18 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=9 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 Participants
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
n=9 Participants
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Number of Participants With AEs and SAEs
Number of Participants with a AE
|
14 Participants
|
5 Participants
|
14 Participants
|
6 Participants
|
|
Number of Participants With AEs and SAEs
Number of Participants with a Treatment-related AE
|
7 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With AEs and SAEs
Number of Participants with a SAE
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With AEs and SAEs
Number of Participants with a Treatment-related SAE
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 16 weeksThe time to first retreatment with intravenous immunoglobulin (IVIg) is defined as the time from the last IVIg administration before randomization until the first IVIg retreatment during the 16-week treatment period
Outcome measures
| Measure |
ARGX-117 Cohort 1
n=18 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=9 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 Participants
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
n=9 Participants
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Time to the First Retreatment With IVIg
|
NA days
Median not evaluable because fewer than 50% of participants were re-treated with IVIg during treatment period. 95% Confidence Interval not estimable due to insufficient number of participants with events.
|
37 days
Interval 16.0 to
The upper limit of the 95% Confidence Interval is not estimable due to an insufficient number of participants with events.
|
NA days
Median not evaluable because fewer than 50% of participants were re-treated with IVIg during treatment period. 95% Confidence Interval not estimable due to insufficient number of participants with events.
|
NA days
Median not evaluable because fewer than 50% of participants were re-treated with IVIg during treatment period. 95% Confidence Interval not estimable due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 16 weeksTime-to-relapse is defined as the time from randomization until a participant met the threshold for clinically meaningful deterioration
Outcome measures
| Measure |
ARGX-117 Cohort 1
n=18 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=9 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 Participants
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
n=9 Participants
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Time-to-relapse
|
NA days
Interval 17.0 to
Data is not estimable due to insufficient number of participants with events.
|
26 days
Interval 7.0 to
Data is not estimable due to insufficient number of participants with events.
|
NA days
Interval 70.0 to
Data is not estimable due to insufficient number of participants with events.
|
28.0 days
Interval 7.0 to 99.0
|
SECONDARY outcome
Timeframe: Up to 16 weeksThe Modified Medical Research Council (mMRC)-10 sum score assesses muscle strength of 10 muscles groups, both sides (left and right). A score between 0 (paralysis) and 5 (normal strength) is assigned for each muscle group. A higher value indicates better muscle strength. The total score, ranging from 0 to 100, is based on the sum of both the left and right side of the body. The Incremental Area Under Curve (iAUC) is the area under the curve of the change from baseline in the Modified Medical Research Council (mMRC)-10 score. A positive AUC indicates a favorable outcome while a negative AUC indicates an unfavorable outcome.
Outcome measures
| Measure |
ARGX-117 Cohort 1
n=18 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=9 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 Participants
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
n=9 Participants
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
iAUC of the Change From Baseline in mMRC-10 Sum Score
|
110.25 mMRC score*weeks
Interval -32.25 to 228.75
|
-182.50 mMRC score*weeks
Interval -362.5 to 130.5
|
283.75 mMRC score*weeks
Interval -17.5 to 432.0
|
-93.50 mMRC score*weeks
Interval -158.5 to -13.0
|
SECONDARY outcome
Timeframe: At week 16The Modified Medical Research Council (mMRC)-14 assesses muscle strength of 14 muscles groups, both sides (left and right). A score between 0 and 5 (normal strength) is assigned. This endpoint is the change from baseline in the average score of the 2 most important muscle groups affected by the disease. It ranges between 0 and 5. A change of more than 0 represents an improvement in strength, and a change less than 0 represents worsening.
Outcome measures
| Measure |
ARGX-117 Cohort 1
n=18 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=9 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 Participants
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
n=9 Participants
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Change From Baseline in the Average Score of the 2 Most Important Muscle Groups as Assessed by the mMRC-14 Sum Score
|
0.50 score on a scale
Interval 0.5 to 0.5
|
0.00 score on a scale
Interval 0.0 to 0.5
|
0.50 score on a scale
Interval 0.0 to 1.0
|
0.00 score on a scale
Interval 0.0 to 0.5
|
SECONDARY outcome
Timeframe: At week 16The Modified Medical Research Council (mMRC)-14 scores range from 0 to 140 with a higher score representing better muscle strength. A change of more than 0 represents an improvement in strength, and a change less than 0 represents worsening.
Outcome measures
| Measure |
ARGX-117 Cohort 1
n=18 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=9 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 Participants
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
n=9 Participants
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Change From Baseline in the mMRC-14 Sum Score
|
4.0 score on a scale
Interval 2.0 to 8.0
|
0.0 score on a scale
Interval -8.0 to 0.0
|
7.0 score on a scale
Interval 1.0 to 11.0
|
1.0 score on a scale
Interval -2.0 to 8.0
|
SECONDARY outcome
Timeframe: Up to 16 weeksThe Modified Medical Research Council (mMRC)-10 scores evaluates motor strength/weakness from 10 predetermined muscle groups. A higher proportion of participants showing a deterioration represents a worsening of the outcome.
Outcome measures
| Measure |
ARGX-117 Cohort 1
n=18 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=9 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 Participants
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
n=9 Participants
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Proportion of Participants Showing a Deterioration of at Least 2 Points as Assessed by the mMRC-10 Sum Score
|
1 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 16 weeksPopulation: Safety analysis set - Only participants with data for these timepoints are included.
Measurement of grip strength (GS) has been done using the Martin vigorimeter in kPa. The incremental Area Under Curve (iAUC) is the area under the curve of the change from baseline of GS daily average. The 3 daily measurements of GS from the left hand and the 3 daily measurements of GS from the right hand have been recorded and the daily average for the left hand and right hand has been calculated, respectively.
Outcome measures
| Measure |
ARGX-117 Cohort 1
n=18 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=9 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 Participants
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
n=9 Participants
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
iAUC of the Change From Baseline in GS Daily Average
Most Affected Hand
|
508.25 kPa*weeks
Interval 237.17 to 1788.08
|
-63.75 kPa*weeks
Interval -591.42 to 671.08
|
1269.67 kPa*weeks
Interval 289.0 to 3139.17
|
1.67 kPa*weeks
Interval -267.67 to 124.0
|
|
iAUC of the Change From Baseline in GS Daily Average
Least Affected Hand
|
356.08 kPa*weeks
Interval -57.17 to 1372.42
|
-363.17 kPa*weeks
Interval -975.67 to 655.5
|
554.00 kPa*weeks
Interval 111.0 to 2847.0
|
-100.33 kPa*weeks
Interval -291.0 to 478.5
|
SECONDARY outcome
Timeframe: At week 16Measurement of grip strength (GS) has been done using the Martin vigorimeter in kPa. The 3 daily measurements of GS from the left hand and the 3 daily measurements of GS from the right hand have been recorded and the daily average for the left hand and right hand has been calculated, respectively. A 3-day moving average has been generated based on the average over the last 3 days of the obtained daily averages for each hand.
Outcome measures
| Measure |
ARGX-117 Cohort 1
n=18 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=9 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 Participants
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
n=9 Participants
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Percent Change From Baseline in GS 3-day Moving Average
Most Affected Hand
|
31.88 Percent change
Interval 0.0 to 53.91
|
1.63 Percent change
Interval -1.96 to 10.42
|
61.48 Percent change
Interval 8.12 to 101.1
|
3.68 Percent change
Interval -3.64 to 16.67
|
|
Percent Change From Baseline in GS 3-day Moving Average
Least Affected Hand
|
13.13 Percent change
Interval 0.25 to 37.68
|
5.69 Percent change
Interval -0.52 to 7.07
|
17.97 Percent change
Interval 6.43 to 69.38
|
4.90 Percent change
Interval 1.61 to 7.69
|
SECONDARY outcome
Timeframe: At week 16The Rasch-built Overall Disability Scale for MMN (MMN-RODS) is a disease-specific PRO instrument constructed to capture activity limitations in patients with MMN. Raw sum scores of the 25-item MMN-RODS (range, 0-50) were converted to a centile metric score ranging from 0 to 100. Lower scores indicated a greater degree of disability.
Outcome measures
| Measure |
ARGX-117 Cohort 1
n=18 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=9 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 Participants
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
n=9 Participants
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Change From Baseline in the MMN-RODS Centile Score
|
6.0 score on a scale
Interval 0.0 to 14.0
|
0.0 score on a scale
Interval -2.0 to 0.0
|
7.5 score on a scale
Interval 0.0 to 17.0
|
0.0 score on a scale
Interval -5.0 to 1.0
|
SECONDARY outcome
Timeframe: At week 16The 9-Hole Peg Test (9-HPT) results are based on the time to complete the assessment with a shorter time representing better muscle strength. A change of less than 0 represents an improvement in strength, and a change more than 0 represents worsening.
Outcome measures
| Measure |
ARGX-117 Cohort 1
n=18 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=9 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=17 Participants
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
n=9 Participants
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Percent Change From Baseline in the Average Time for Upper Extremity (Arm and Hand) Function
Dominant Hand
|
-10.760 Percent change
Interval -41.463 to -1.25
|
-5.691 Percent change
Interval -16.049 to 9.254
|
-8.571 Percent change
Interval -20.907 to 0.0
|
-12.150 Percent change
Interval -16.212 to 2.5
|
|
Percent Change From Baseline in the Average Time for Upper Extremity (Arm and Hand) Function
Non-Dominant Hand
|
-5.236 Percent change
Interval -23.529 to 6.343
|
-3.394 Percent change
Interval -20.69 to 5.0
|
-14.286 Percent change
Interval -25.714 to -8.725
|
-1.402 Percent change
Interval -7.368 to 4.762
|
SECONDARY outcome
Timeframe: At week 16The EuroQol 5-Dimension 5-Level (EQ-5D-5L) scale includes five dimensions: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension is ranked with a level 1-5 with level 1 being no problems and level 5 representing extreme problems.
Outcome measures
| Measure |
ARGX-117 Cohort 1
n=18 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=9 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 Participants
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
n=9 Participants
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Anxiety/Depression · 4 - Severe Problem
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Anxiety/Depression · 1 - No Problem
|
13 Participants
|
2 Participants
|
15 Participants
|
5 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Anxiety/Depression · 2 - Slight Problem
|
4 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Anxiety/Depression · 5 - Unable to
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Anxiety/Depression · 3 - Moderate Problem
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Mobility · 1 - No Problem
|
9 Participants
|
3 Participants
|
11 Participants
|
2 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Mobility · 2 - Slight Problem
|
2 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Mobility · 3 - Moderate Problem
|
6 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Mobility · 4 - Severe Problem
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Mobility · 5 - Unable to
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Self-Care · 1 - No Problem
|
5 Participants
|
3 Participants
|
8 Participants
|
3 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Self-Care · 2 - Slight Problem
|
8 Participants
|
4 Participants
|
8 Participants
|
5 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Self-Care · 3 - Moderate Problem
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Self-Care · 4 - Severe Problem
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Self-Care · 5 - Unable to
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Usual Activities · 1 - No Problem
|
5 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Usual Activities · 2 - Slight Problem
|
6 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Usual Activities · 3 - Moderate Problem
|
6 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Usual Activities · 4 - Severe Problem
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Usual Activities · 5 - Unable to
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Pain/Discomfort · 1 - No Problem
|
9 Participants
|
6 Participants
|
10 Participants
|
2 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Pain/Discomfort · 2 - Slight Problem
|
5 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Pain/Discomfort · 3 - Moderate Problem
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Pain/Discomfort · 4 - Severe Problem
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale
Pain/Discomfort · 5 - Unable to
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At week 16The EQ-5D-5L visual analog scale is from 0-100 with 0 representing the worst health. A change of more than 0 represents an improvement in health, and a change of less than 0 represents worsening.
Outcome measures
| Measure |
ARGX-117 Cohort 1
n=18 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=9 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 Participants
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
n=9 Participants
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Change From Baseline in Quality of Life Using EQ-5D-5L Visual Analog Scale
|
5.0 score on a scale
Interval 0.0 to 13.0
|
7.0 score on a scale
Interval -8.0 to 10.0
|
6.0 score on a scale
Interval 2.0 to 8.0
|
-6.0 score on a scale
Interval -10.0 to 9.0
|
SECONDARY outcome
Timeframe: At week 16The Chronic Acquired Polyneuropathy Patient-reported Index (CAP-PRI) assesses disease-specific quality of life. This instrument includes the assessment of 15 items yielding a total score ranging from 0 to 30. A change of less than 0 represents an improvement in health, and a change more than 0 represents worsening.
Outcome measures
| Measure |
ARGX-117 Cohort 1
n=18 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=9 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 Participants
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
n=9 Participants
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Change From Baseline in the CAP-PRI
|
-2.5 score on a scale
Interval -6.0 to -1.0
|
0.0 score on a scale
Interval -1.0 to 2.0
|
-2.0 score on a scale
Interval -5.0 to -1.0
|
1.0 score on a scale
Interval -1.0 to 2.0
|
SECONDARY outcome
Timeframe: Up to 16 weeksPatient Global Impression of Change (PGI-C) scale ranks a patients condition from 1-7 with 1 representing the most improvement and 7 representing the most decline in their condition.
Outcome measures
| Measure |
ARGX-117 Cohort 1
n=18 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=9 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 Participants
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
n=9 Participants
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Proportion of Participants by Level of Improvement Using the PGI-C Scale
2 - Much improved
|
3 Participants
|
1 Participants
|
8 Participants
|
2 Participants
|
|
Proportion of Participants by Level of Improvement Using the PGI-C Scale
3 - Minimally improved
|
7 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Proportion of Participants by Level of Improvement Using the PGI-C Scale
4 - No change
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Proportion of Participants by Level of Improvement Using the PGI-C Scale
5 - Minimally worse
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Proportion of Participants by Level of Improvement Using the PGI-C Scale
6 - Much worse
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Proportion of Participants by Level of Improvement Using the PGI-C Scale
7 - Very much worse
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Proportion of Participants by Level of Improvement Using the PGI-C Scale
1 - Very much improved
|
7 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 16 weeks9-item Fatigue Severity Scale (FSS) average score is the sum of the 9 items divided by the number of items. It ranges from 0 to 7 a higher score representing more severe fatigue. A change of less than 0 indicates an improvement.
Outcome measures
| Measure |
ARGX-117 Cohort 1
n=18 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=9 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 Participants
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
n=9 Participants
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Change From Baseline in the 9-item FSS Average Total Score
|
-0.444 score on a scale
Interval -1.556 to 0.0
|
0.222 score on a scale
Interval 0.111 to 1.222
|
-0.111 score on a scale
Interval -0.556 to 0.111
|
0.222 score on a scale
Interval -0.222 to 1.0
|
SECONDARY outcome
Timeframe: Up to 16 weeksPopulation: Safety analysis set - only participants with HRPQ data are shown. This is limited to employed/partially employed participants.
The Health-Related Productivity Questionnaire (HRPQ) provides data related to missed hours at work or educational activities and reduced effectiveness during any attempted work.
Outcome measures
| Measure |
ARGX-117 Cohort 1
n=18 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=9 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 Participants
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
n=9 Participants
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Percent of Total Hours for Work-related and Household Chore Activities Lost, as Part of the HRPQ
Work Activities lost
|
10.00 Percent
Interval 0.0 to 15.0
|
36.00 Percent
Interval 0.0 to 46.0
|
0.00 Percent
Interval 0.0 to 12.13
|
24.17 Percent
Interval 17.5 to 37.78
|
|
Percent of Total Hours for Work-related and Household Chore Activities Lost, as Part of the HRPQ
Household Chore Activities lost
|
33.33 Percent
Interval 10.0 to 60.0
|
20.00 Percent
Interval 12.5 to 64.5
|
15.00 Percent
Interval 0.0 to 35.0
|
43.75 Percent
Interval 27.62 to 60.0
|
SECONDARY outcome
Timeframe: Up to 16 weeksEach Treatment Satisfaction Questionnaire for Medication-14 items (TSQM-14) domain score ranges from 0-100 with higher scores representing greater satisfaction with the treatment. A change greater than 0 indicates an improvement in satisfaction.
Outcome measures
| Measure |
ARGX-117 Cohort 1
n=18 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=9 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 Participants
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
n=9 Participants
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Change From Baseline in Effectiveness, Side Effects, Convenience, and Overall Satisfaction Scores as Assessed by the TSQM-14
Effectiveness
|
0.000 score on a scale
Interval -16.667 to 27.778
|
-22.222 score on a scale
Interval -33.333 to -16.667
|
25.000 score on a scale
Interval 0.0 to 38.889
|
-11.111 score on a scale
Interval -16.667 to 5.556
|
|
Change From Baseline in Effectiveness, Side Effects, Convenience, and Overall Satisfaction Scores as Assessed by the TSQM-14
Side effects
|
0.000 score on a scale
Interval 0.0 to 18.75
|
0.000 score on a scale
Interval 0.0 to 18.75
|
0.000 score on a scale
Interval 0.0 to 0.0
|
0.000 score on a scale
Interval 0.0 to 12.5
|
|
Change From Baseline in Effectiveness, Side Effects, Convenience, and Overall Satisfaction Scores as Assessed by the TSQM-14
Convenience
|
5.556 score on a scale
Interval 0.0 to 22.222
|
5.556 score on a scale
Interval 0.0 to 5.556
|
5.556 score on a scale
Interval 0.0 to 11.111
|
-5.556 score on a scale
Interval -11.111 to 5.556
|
|
Change From Baseline in Effectiveness, Side Effects, Convenience, and Overall Satisfaction Scores as Assessed by the TSQM-14
Overall Satisfaction
|
3.6 score on a scale
Interval -7.1 to 28.6
|
-14.3 score on a scale
Interval -28.6 to -14.3
|
3.6 score on a scale
Interval 0.0 to 28.6
|
-14.3 score on a scale
Interval -21.4 to -7.1
|
SECONDARY outcome
Timeframe: Up to 16 weeksPopulation: The number analyzed in some rows differs due to missing participant data. At certain timepoints 0 analyzed participants are reported since no ARGX-117 was administered at those timepoints, as per dosing regimens.
Outcome measures
| Measure |
ARGX-117 Cohort 1
n=18 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=18 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Maximum Empasiprubart Serum Concentrations (Cmax)
Day 1
|
777.1 ug/mL
Standard Deviation 202.6
|
400.1 ug/mL
Standard Deviation 73.4
|
—
|
—
|
|
Maximum Empasiprubart Serum Concentrations (Cmax)
Day 8
|
590.8 ug/mL
Standard Deviation 164.0
|
273.8 ug/mL
Standard Deviation 88.1
|
—
|
—
|
|
Maximum Empasiprubart Serum Concentrations (Cmax)
Day 15
|
672.3 ug/mL
Standard Deviation 118.4
|
340.5 ug/mL
Standard Deviation 59.0
|
—
|
—
|
|
Maximum Empasiprubart Serum Concentrations (Cmax)
Day 22
|
802.3 ug/mL
Standard Deviation 202.4
|
356.2 ug/mL
Standard Deviation 42.3
|
—
|
—
|
|
Maximum Empasiprubart Serum Concentrations (Cmax)
Day 29
|
725.2 ug/mL
Standard Deviation 176.5
|
394.1 ug/mL
Standard Deviation 60.6
|
—
|
—
|
|
Maximum Empasiprubart Serum Concentrations (Cmax)
Day 43
|
797.3 ug/mL
Standard Deviation 153.2
|
—
|
—
|
—
|
|
Maximum Empasiprubart Serum Concentrations (Cmax)
Day 57
|
819.9 ug/mL
Standard Deviation 187.6
|
391.6 ug/mL
Standard Deviation 128.1
|
—
|
—
|
|
Maximum Empasiprubart Serum Concentrations (Cmax)
Day 71
|
871.9 ug/mL
Standard Deviation 183.4
|
—
|
—
|
—
|
|
Maximum Empasiprubart Serum Concentrations (Cmax)
Day 85
|
876.3 ug/mL
Standard Deviation 222.5
|
349.4 ug/mL
Standard Deviation 71.1
|
—
|
—
|
|
Maximum Empasiprubart Serum Concentrations (Cmax)
Day 99
|
891.8 ug/mL
Standard Deviation 125.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At week 16Population: PD set - All participants for whom at least 1 postbaseline value for pharmacodynamic parameters was available. Only participants with available data at week 16 are reported. Due to the small sample size (9 participants) in each placebo group, it was prespecified to pool the 2 placebo cohorts for the PD assessments.
Outcome measures
| Measure |
ARGX-117 Cohort 1
n=18 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=18 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 Participants
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Percent Change From Baseline in Free C2, Total C2, and Functional Complement Activity (CH50)
Free C2
|
-98.915 Percent change
Interval -99.031 to -98.635
|
-98.079 Percent change
Interval -98.532 to -97.324
|
-0.669 Percent change
Interval -13.876 to 7.625
|
—
|
|
Percent Change From Baseline in Free C2, Total C2, and Functional Complement Activity (CH50)
Total C2
|
331.82 Percent change
Interval 314.29 to 475.34
|
296.34 Percent change
Interval 219.8 to 332.0
|
3.85 Percent change
Interval -4.0 to 10.88
|
—
|
|
Percent Change From Baseline in Free C2, Total C2, and Functional Complement Activity (CH50)
CH50
|
-89.01 Percent change
Interval -95.68 to -83.92
|
-64.33 Percent change
Interval -69.0 to -45.27
|
-1.50 Percent change
Interval -13.04 to 9.71
|
—
|
SECONDARY outcome
Timeframe: Up to 16 weeksPopulation: Only ADA-evaluable participants were analyzed for this outcome measure. ADA-evaluable participants were classified as treatment-boosted ADA, treatment-induced ADA, treatment-unaffected ADA, or ADA negative. Due to the small sample size (9 participants) in each placebo group, it was prespecified to pool the 2 placebo cohorts for the immunogenicity assessment.
Outcome measures
| Measure |
ARGX-117 Cohort 1
n=16 Participants
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=18 Participants
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 Participants
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Incidence of Antidrug Antibodies (ADA) Against Empasiprubart
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
Adverse Events
ARGX-117 Cohort 1
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo Cohort 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
ARGX-117 Cohort 2
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo Cohort 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ARGX-117 Cohort 1
n=18 participants at risk
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=9 participants at risk
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 participants at risk
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
n=9 participants at risk
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Infections and infestations
Pneumonia
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
Other adverse events
| Measure |
ARGX-117 Cohort 1
n=18 participants at risk
Participants receiving a single dose of 30 mg/kg followed by 4 once- weekly doses of 10 mg/kg and a maintenance regimen of a single dose of 10 mg/kg every 2 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 1
n=9 participants at risk
Participants received placebo via intravenous (IV) infusion
|
ARGX-117 Cohort 2
n=18 participants at risk
Participants receiving a single dose of 15 mg/kg followed by 4 once- weekly doses of 5 mg/kg and a maintenance regimen of a single dose of 5 mg/kg every 4 weeks until the end of the DBTP (through intravenous infusions)
|
Placebo Cohort 2
n=9 participants at risk
Participants received placebo via IV infusion
|
|---|---|---|---|---|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Infections and infestations
Paronychia
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Infections and infestations
Anal fungal infection
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Infections and infestations
COVID-19
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
22.2%
4/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
33.3%
3/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Infections and infestations
Influenza
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
2/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
General disorders
Fatigue
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
2/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
22.2%
2/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
General disorders
Infusion site rash
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
General disorders
Oedema peripheral
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
General disorders
Vaccination site pain
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
General disorders
Asthenia
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
General disorders
Chest discomfort
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
General disorders
Chest pain
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
General disorders
Chills
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
General disorders
Feeling cold
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
General disorders
Injection site pain
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
General disorders
Pyrexia
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Nervous system disorders
Headache
|
27.8%
5/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
27.8%
5/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
22.2%
2/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Nervous system disorders
Fine motor skill dysfunction
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Nervous system disorders
Somnolence
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Investigations
Blood urine present
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Investigations
Protein urine
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
2/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Investigations
Antinuclear antibody increased
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Investigations
Bilirubin urine
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
16.7%
3/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Gastrointestinal disorders
Gastritis
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Renal and urinary disorders
Haematuria
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Eye disorders
Eye irritation
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
5.6%
1/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
11.1%
1/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/18 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
0.00%
0/9 • Up to 80 weeks
Adverse events were assessed at each participant visit. Laboratory abnormalities were reported as AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place