Trial Outcomes & Findings for An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness (NCT NCT03669588)

Last Updated: 2022-02-08

Results Overview

The MG-ADL is an 8-item patient-reported scale to assess MG symptoms and their effects on daily activities. The scale comprises 2 items on daily life activities and 6 items on symptoms. The MG-ADL total score range is 0-24, with higher scores indicative of greater disease severity. A patient was considered an MG-ADL responder during C1 if there was a reduction of ≥2 points on the MG-ADL total score (compared to baseline of C1 \[C1B\]) for ≥4 consecutive weeks with the first reduction occurring no later than 1 week after the last infusion of IMP in C1.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

167 participants

Primary outcome timeframe

Baseline up to Day 63 (end of TC1)

Results posted on

2022-02-08

Participant Flow

Study was conducted in generalized myasthenia gravis (gMG) patients at 56 sites worldwide. Patients were randomized 1:1 within each stratum (Japanese/non-Japanese, acetylcholine receptor-antibody \[AChR-Ab\] status and standard of care \[SoC; ie, concomitant gMG treatment\]) to receive ARGX-113 intravenous (IV) 10 milligrams/kilogram (mg/kg) or placebo, in addition to SoC. Patients completing the study were eligible to roll over into a follow-up study ARGX-113-1705.

Total study duration was up to 28 weeks, including a 2-week screening period, an initial 8-week treatment cycle (TC) and intertreatment cycle (ITC) of variable length depending on the patient. Patients had to be on a stable dose of SoC and not have received immunoglobulins by IV, subcutaneous or intramuscular route, or plasma exchange, \< 1 month prior to screening. The study included both AChR-Ab seropositive and seronegative patients; AChR-Ab detection in serum was performed during screening.

Participant milestones

Participant milestones
Measure	ARGX-113 Patients received ARGX-113 IV 10 mg/kg administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle. Each 8-week TC comprised a 3-week treatment period and a 5-week follow-up period. At the end of each TC, patients entered the ITC period consisting of visits every 2 weeks. At each ITC visit, retreatment criteria were evaluated to determine if the patient was eligible to enter the next cycle for retreatment, based on clinical response as measured by the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale.	Placebo Patients received matching placebo administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle. Each 8-week TC comprised a 3-week treatment period and a 5-week follow-up period. At the end of each TC, patients entered the ITC period consisting of visits every 2 weeks. At each ITC visit, retreatment criteria were evaluated to determine if the patient was eligible to enter the next cycle for retreatment, based on clinical response as measured by the MG-ADL scale.
Overall Study STARTED	84	83
Overall Study COMPLETED	80	76
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	ARGX-113 Patients received ARGX-113 IV 10 mg/kg administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle. Each 8-week TC comprised a 3-week treatment period and a 5-week follow-up period. At the end of each TC, patients entered the ITC period consisting of visits every 2 weeks. At each ITC visit, retreatment criteria were evaluated to determine if the patient was eligible to enter the next cycle for retreatment, based on clinical response as measured by the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale.	Placebo Patients received matching placebo administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle. Each 8-week TC comprised a 3-week treatment period and a 5-week follow-up period. At the end of each TC, patients entered the ITC period consisting of visits every 2 weeks. At each ITC visit, retreatment criteria were evaluated to determine if the patient was eligible to enter the next cycle for retreatment, based on clinical response as measured by the MG-ADL scale.
Overall Study Adverse Event	1	0
Overall Study Physician Decision	0	1
Overall Study Protocol Violation	1	0
Overall Study Sponsor Decision	1	1
Overall Study Withdrawal by Subject	1	4
Overall Study Rescue Therapy Needed	0	1

Baseline Characteristics

An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ARGX-113 n=84 Participants Patients received ARGX-113 IV 10 mg/kg administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.	Placebo n=83 Participants Patients received matching placebo administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.	Total n=167 Participants Total of all reporting groups
Age, Continuous	45.9 years STANDARD_DEVIATION 14.41 • n=5 Participants	48.2 years STANDARD_DEVIATION 14.97 • n=7 Participants	47.0 years STANDARD_DEVIATION 14.69 • n=5 Participants
Age, Customized 18 - <65 years	73 Participants n=5 Participants	69 Participants n=7 Participants	142 Participants n=5 Participants
Age, Customized >= 65 years	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants	55 Participants n=7 Participants	118 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	28 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	69 Participants n=5 Participants	72 Participants n=7 Participants	141 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	69 Participants n=5 Participants	73 Participants n=7 Participants	142 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Concomitant gMG treatment Nonsteroidal Immunosuppressive Drugs (NSIDs)	51 Participants n=5 Participants	51 Participants n=7 Participants	102 Participants n=5 Participants
Concomitant gMG treatment No NSIDs	33 Participants n=5 Participants	32 Participants n=7 Participants	65 Participants n=5 Participants
AChR-Ab status Positive	65 Participants n=5 Participants	64 Participants n=7 Participants	129 Participants n=5 Participants
AChR-Ab status Negative	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to Day 63 (end of TC1)

Population: Analysis was performed in the AChR-Ab seropositive population using the modified intention-to-treat (mITT) analysis set which included all randomized patients with a value for the MG-ADL total score at baseline and at least 1 postbaseline timepoint.

Outcome measures

Outcome measures
Measure	ARGX-113 n=65 Participants Patients received ARGX-113 IV 10 mg/kg administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.	Placebo n=64 Participants Patients received matching placebo administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.
Percentage of MG-ADL Responders During Cycle 1 (C1); Analyzed in the AChR-Ab Seropositive Population	67.7 percentage of patients	29.7 percentage of patients

SECONDARY outcome

Timeframe: Baseline up to Day 63 (end of TC1)

Population: Analysis was performed in the AChR-Ab seropositive population using the mITT analysis set which included all randomized patients with a value for the MG-ADL total score at baseline and at least 1 postbaseline timepoint.

The QMG scale quantifies disease severity based on impairments of body functions and structures as defined by the International Classification of Disability and Health. The QMG scale consists of 13 items that measure endurance or fatigability, and accounts for fluctuations in disease state. The QMG total score range is 0-39, with higher scores indicative of greater disease severity. A patient was considered a QMG responder during C1 if there was a reduction of ≥3-points on the QMG total score (compared to C1B) for ≥4 consecutive weeks with the first reduction occurring no later than 1 week after the last infusion of IMP in C1.

Outcome measures

Outcome measures
Measure	ARGX-113 n=65 Participants Patients received ARGX-113 IV 10 mg/kg administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.	Placebo n=64 Participants Patients received matching placebo administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.
Percentage of Quantitative Myasthenia Gravis (QMG) Responders During C1; Analyzed in the AChR-Ab Seropositive Population	63.1 percentage of patients	14.1 percentage of patients

SECONDARY outcome

Timeframe: Baseline up to Day 63 (end of TC1)

Population: Analysis was performed in the overall population (including both AChR-Ab seropositive and seronegative patients) using the mITT analysis set which included all randomized patients with a value for the MG-ADL total score at baseline and at least 1 postbaseline timepoint.

The percentage of MG-ADL responders during C1 in the overall population is reported for this secondary end point; percentage of MG-ADL responders during C1 in the AChR-Ab seropositive population is reported previously as a primary end point.

Outcome measures

Outcome measures
Measure	ARGX-113 n=84 Participants Patients received ARGX-113 IV 10 mg/kg administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.	Placebo n=83 Participants Patients received matching placebo administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.
Percentage of MG-ADL Responders During C1; Analyzed in the Overall Population	67.9 percentage of patients	37.3 percentage of patients

SECONDARY outcome

Timeframe: Baseline up to Day 126

An MG-ADL CMI was defined as a reduction of ≥2 points on the total MG-ADL score compared to study entry baseline (SEB).

Outcome measures

Outcome measures
Measure	ARGX-113 n=65 Participants Patients received ARGX-113 IV 10 mg/kg administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.	Placebo n=64 Participants Patients received matching placebo administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.
Percentage of Time That Patients Had a Clinically Meaningful Improvement (CMI) in MG-ADL Total Score up to and Including Day 126; Analyzed in the AChR-Ab Seropositive Population	48.714 percentage of time Standard Error 6.163	26.649 percentage of time Standard Error 6.316

SECONDARY outcome

Timeframe: Week 4 up to Day 182 (end of study [EoS])

Time to qualify for retreatment was defined as time from the Week 4 assessment until the first visit with a \<2-point reduction compared to SEB in the MG-ADL total score and MG-ADL total score ≥5 points with \>50% of the total score attributable to nonocular symptoms.

Outcome measures

Outcome measures
Measure	ARGX-113 n=65 Participants Patients received ARGX-113 IV 10 mg/kg administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.	Placebo n=64 Participants Patients received matching placebo administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.
Time From Week 4 to Qualify for Retreatment; Analyzed in the AChR-Ab Seropositive Population	35.0 days Interval 29.0 to 43.0	8.0 days Interval 1.0 to 30.0

SECONDARY outcome

Timeframe: Baseline up to Day 63 (end of TC1)

A patient was considered an early MG-ADL responder during C1 if there was a reduction of ≥2 points on the MG-ADL total score (compared to C1B) for ≥4 consecutive weeks with the first reduction occurring no later than Week 2 (ie, after 1 or maximum 2 infusions of IMP in C1).

Outcome measures

Outcome measures
Measure	ARGX-113 n=65 Participants Patients received ARGX-113 IV 10 mg/kg administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.	Placebo n=64 Participants Patients received matching placebo administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.
Percentage of Early MG-ADL Responders During C1; Analyzed in the AChR-Ab Seropositive Population	56.9 percentage of patients	25.0 percentage of patients

Adverse Events

ARGX-113

Serious events: 4 serious events

Other events: 49 other events

Deaths: 0 deaths

Placebo

Serious events: 7 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ARGX-113 n=84 participants at risk Patients received ARGX-113 IV 10 mg/kg administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.	Placebo n=83 participants at risk Patients received matching placebo administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.
Blood and lymphatic system disorders Thrombocytosis	1.2% 1/84 • Number of events 1 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	0.00% 0/83 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
Cardiac disorders Atrial fibrillation	0.00% 0/84 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	1.2% 1/83 • Number of events 1 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
Cardiac disorders Myocardial ischaemia	0.00% 0/84 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	1.2% 1/83 • Number of events 1 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
General disorders Therapeutic product ineffective	0.00% 0/84 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	1.2% 1/83 • Number of events 1 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
Infections and infestations Upper respiratory tract infection	0.00% 0/84 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	1.2% 1/83 • Number of events 1 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/84 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	1.2% 1/83 • Number of events 1 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/84 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	1.2% 1/83 • Number of events 1 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
Musculoskeletal and connective tissue disorders Spinal ligament ossification	0.00% 0/84 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	1.2% 1/83 • Number of events 1 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	1.2% 1/84 • Number of events 1 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	0.00% 0/83 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
Nervous system disorders Myasthenia gravis	1.2% 1/84 • Number of events 1 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	2.4% 2/83 • Number of events 2 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
Nervous system disorders Myasthenia gravis crisis	0.00% 0/84 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	1.2% 1/83 • Number of events 1 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
Psychiatric disorders Depression	1.2% 1/84 • Number of events 1 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	0.00% 0/83 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.

Other adverse events

Other adverse events
Measure	ARGX-113 n=84 participants at risk Patients received ARGX-113 IV 10 mg/kg administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.	Placebo n=83 participants at risk Patients received matching placebo administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.
Gastrointestinal disorders Diarrhoea	7.1% 6/84 • Number of events 6 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	10.8% 9/83 • Number of events 14 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
Gastrointestinal disorders Nausea	8.3% 7/84 • Number of events 7 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	10.8% 9/83 • Number of events 15 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
Infections and infestations Bronchitis	6.0% 5/84 • Number of events 6 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	2.4% 2/83 • Number of events 2 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
Infections and infestations Nasopharyngitis	11.9% 10/84 • Number of events 12 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	18.1% 15/83 • Number of events 17 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
Musculoskeletal and connective tissue disorders Myalgia	6.0% 5/84 • Number of events 6 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	1.2% 1/83 • Number of events 3 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
Nervous system disorders Dizziness	3.6% 3/84 • Number of events 5 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	6.0% 5/83 • Number of events 5 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
Nervous system disorders Headache	28.6% 24/84 • Number of events 40 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	27.7% 23/83 • Number of events 39 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
Respiratory, thoracic and mediastinal disorders Cough	3.6% 3/84 • Number of events 3 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	6.0% 5/83 • Number of events 5 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.6% 3/84 • Number of events 3 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	8.4% 7/83 • Number of events 7 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
Vascular disorders Hypertension	3.6% 3/84 • Number of events 4 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	7.2% 6/83 • Number of events 6 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
Infections and infestations Upper respiratory tract infection	10.7% 9/84 • Number of events 11 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	4.8% 4/83 • Number of events 4 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.
Infections and infestations Urinary tract infection	9.5% 8/84 • Number of events 9 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.	4.8% 4/83 • Number of events 4 • Treatment-emergent adverse events were monitored from first administration of IMP on Day 1 until the EoS (up to a maximum of approximately 182 days). The safety analysis set included patients in the randomized population who received at least a partial dose of IMP.

Additional Information

Regulatory Manager

argenx BVBA

Phone: +32 93103400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place