Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus) (NCT NCT04598451)

Last Updated: 2024-10-01

Results Overview

Proportion of participants with pemphigus vulgaris who had CRmin within 30 weeks, defined as the absence of new lesions and complete healing of established lesions while the participant was receiving prednisone at ≤10 mg/day for at least 8 weeks.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

222 participants

Primary outcome timeframe

up to 30 weeks treatment period

Results posted on

2024-10-01

Participant Flow

Participant milestones

Participant milestones
Measure	Efgartigimod PH20 SC Patients randomized to receive weekly administrations of efgartigimod PH20 until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol	Placebo PH20 SC Patients randomized to receive weekly administrations of placebo PH20 SC until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol
Overall Study STARTED	147	75
Overall Study COMPLETED	104	46
Overall Study NOT COMPLETED	43	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Efgartigimod PH20 SC Patients randomized to receive weekly administrations of efgartigimod PH20 until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol	Placebo PH20 SC Patients randomized to receive weekly administrations of placebo PH20 SC until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol
Overall Study Adverse Event	3	2
Overall Study Withdrawal by Subject	3	7
Overall Study Lost to Follow-up	2	0
Overall Study Physician Decision	4	1
Overall Study Requires Prohibited Medication	1	0
Overall Study lack of efficacy, geopolitical situation in Ukraine, flares after CRmin, SAE due to prednisone, etc	30	19

Baseline Characteristics

A Study to Assess the Efficacy and Safety of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Efgartigimod PH20 SC n=147 Participants Patients randomized to receive weekly administrations of efgartigimod PH20 until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol	Placebo PH20 SC n=75 Participants Patients randomized to receive weekly administrations of placebo PH20 SC until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol	Total n=222 Participants Total of all reporting groups
Age, Continuous	48.9 years STANDARD_DEVIATION 12.55 • n=5 Participants	52.3 years STANDARD_DEVIATION 13.37 • n=7 Participants	50.1 years STANDARD_DEVIATION 12.90 • n=5 Participants
Sex: Female, Male Female	73 Participants n=5 Participants	42 Participants n=7 Participants	115 Participants n=5 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	33 Participants n=7 Participants	107 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	49 Participants n=5 Participants	16 Participants n=7 Participants	65 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	96 Participants n=5 Participants	53 Participants n=7 Participants	149 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	144 Participants n=5 Participants	70 Participants n=7 Participants	214 Participants n=5 Participants
Pemphigus Vulgaris (PV)	124 Participants n=5 Participants	66 Participants n=7 Participants	190 Participants n=5 Participants
Pemphigus Foliaceus (PF)	23 Participants n=5 Participants	9 Participants n=7 Participants	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 30 weeks treatment period

Population: Randomized participants with pemphigus vulgaris (PV) who received at least part of a dose of efgartigimod PH20 SC or placebo PH20 SC. These participants also received prednisone with a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted per protocol

Outcome measures

Outcome measures
Measure	Efgartigimod PH20 SC n=124 Participants Patients randomized to receive weekly administrations of efgartigimod PH20 until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol	Placebo PH20 SC n=66 Participants Patients randomized to receive weekly administrations of placebo PH20 SC until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol
Number of Pemphigus Vulgaris (PV) Participants Who Achieve Complete Clinical Remission (CR) on Minimal Prednisone Therapy	44 Participants	20 Participants

SECONDARY outcome

Timeframe: up to 30 weeks treatment period

Population: Randomized participants with pemphigus vulgaris or pemphigus foliaceus who received at least part of a dose of efgartigimod PH20 SC or placebo PH20 SC. These participants also received prednisone with a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted per protocol.

Proportion of participants with pemphigus vulgaris and pemphigus foliaceus who had CRmin within 30 weeks, defined as the absence of new lesions and complete healing of established lesions while the participant was receiving prednisone at ≤10 mg/day for at least 8 weeks.

Outcome measures

Outcome measures
Measure	Efgartigimod PH20 SC n=147 Participants Patients randomized to receive weekly administrations of efgartigimod PH20 until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol	Placebo PH20 SC n=75 Participants Patients randomized to receive weekly administrations of placebo PH20 SC until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol
Number of Pemphigus Vulgaris (PV) and Pemphigus Foliaceus (PF) Participants Who Achieve Complete Clinical Remission (CR) on Minimal Prednisone Therapy Within 30 Weeks	55 Participants	24 Participants

SECONDARY outcome

Timeframe: Up to 30 weeks

Normalized Cumulative prednisone dose (NCPD, mg/kg/day) is the average daily intake of all weight-adjusted prednisone doses received during the study, taking into account the number of days in study

Outcome measures

Outcome measures
Measure	Efgartigimod PH20 SC n=124 Participants Patients randomized to receive weekly administrations of efgartigimod PH20 until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol	Placebo PH20 SC n=66 Participants Patients randomized to receive weekly administrations of placebo PH20 SC until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol
Normalized Cumulative Prednisone Dose During the Treatment Period in Pemphigus Vulgaris Participants	0.416 mg/kg/day Standard Deviation 0.215	0.444 mg/kg/day Standard Deviation 0.232

SECONDARY outcome

Timeframe: Up to 30 weeks

Time to complete remission (absence of new lesions and complete healing of established lesions) in participants with pemphigus vulgaris

Outcome measures

Outcome measures
Measure	Efgartigimod PH20 SC n=124 Participants Patients randomized to receive weekly administrations of efgartigimod PH20 until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol	Placebo PH20 SC n=66 Participants Patients randomized to receive weekly administrations of placebo PH20 SC until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol
Time to Complete Clinical Remission (CR) in Pemphigus Vulgaris Participants	106 days Interval 79.0 to 161.0	120 days Interval 85.0 to 188.0

SECONDARY outcome

Timeframe: Up to 30 weeks

Time to disease control in participants with pemphigus vulgaris (Absence of new lesions and the start of healing of established lesions)

Outcome measures

Outcome measures
Measure	Efgartigimod PH20 SC n=124 Participants Patients randomized to receive weekly administrations of efgartigimod PH20 until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol	Placebo PH20 SC n=66 Participants Patients randomized to receive weekly administrations of placebo PH20 SC until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol
Time to Disease Control (DC) in Pemphigus Vulgaris (PV) Participants	16 days Interval 15.0 to 21.0	15 days Interval 8.0 to 17.0

SECONDARY outcome

Timeframe: Up to 30 weeks

Normalized Cumulative prednisone dose (NCPD, mg/kg/day) is the average daily intake of all weight-adjusted prednisone doses received during the study, taking into account the number of days in study

Outcome measures

Outcome measures
Measure	Efgartigimod PH20 SC n=147 Participants Patients randomized to receive weekly administrations of efgartigimod PH20 until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol	Placebo PH20 SC n=75 Participants Patients randomized to receive weekly administrations of placebo PH20 SC until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol
Normalized Cumulative Prednisone Dose During the Treatment Period in Pemphigus Vulgaris and Pemphigus Foliaceus Participants	0.403 mg/kg/day Standard Deviation 0.210	0.431 mg/kg/day Standard Deviation 0.225

SECONDARY outcome

Timeframe: Up to 30 weeks

Time to complete remission (absence of new lesions and complete healing of established lesions) in participants with pemphigus vulgaris and pemphigus foliaceus

Outcome measures

Outcome measures
Measure	Efgartigimod PH20 SC n=147 Participants Patients randomized to receive weekly administrations of efgartigimod PH20 until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol	Placebo PH20 SC n=75 Participants Patients randomized to receive weekly administrations of placebo PH20 SC until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol
Time to Complete Clinical Remission (CR) in Pemphigus Vulgaris and Pemphigus Foliaceus Participants	106 days Interval 84.0 to 142.0	113 days Interval 81.0 to 149.0

SECONDARY outcome

Timeframe: Up to 30 weeks

Time to disease control in participants with pemphigus vulgaris and pemphigus foliaceus (Absence of new lesions and the start of healing of established lesions)

Outcome measures

Outcome measures
Measure	Efgartigimod PH20 SC n=147 Participants Patients randomized to receive weekly administrations of efgartigimod PH20 until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol	Placebo PH20 SC n=75 Participants Patients randomized to receive weekly administrations of placebo PH20 SC until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol
Time to Disease Control in Pemphigus Vulgaris and Pemphigus Foliaceus Participants	15 days Interval 15.0 to 17.0	15 days Interval 9.0 to 16.0

Adverse Events

Efgartigimod PH20 SC

Serious events: 18 serious events

Other events: 113 other events

Deaths: 0 deaths

Placebo PH20 SC

Serious events: 10 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Regulatory Manager

Argenx

Phone: Please email:

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Efgartigimod PH20 SC n=147 participants at risk Patients randomized to receive weekly administrations of efgartigimod PH20 until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol	Placebo PH20 SC n=75 participants at risk Patients randomized to receive weekly administrations of placebo PH20 SC until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol
Blood and lymphatic system disorders INCREASED TENDENCY TO BRUISE	3.4% 5/147 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).	6.7% 5/75 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).
General disorders INJECTION SITE ERYTHEMA	5.4% 8/147 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).	1.3% 1/75 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).
Infections and infestations COVID-19	11.6% 17/147 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).	4.0% 3/75 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).
Infections and infestations NASOPHARYNGITIS	2.7% 4/147 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).	6.7% 5/75 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).
Infections and infestations ORAL CANDIDIASIS	4.1% 6/147 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).	8.0% 6/75 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).
Infections and infestations URINARY TRACT INFECTION	2.7% 4/147 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).	8.0% 6/75 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).
Investigations BLOOD LACTATE DEHYDROGENASE INCREASED	6.8% 10/147 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).	4.0% 3/75 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).
Metabolism and nutrition disorders HYPERTRIGLYCERIDAEMIA	7.5% 11/147 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).	2.7% 2/75 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).
Musculoskeletal and connective tissue disorders MYOPATHY	6.1% 9/147 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).	10.7% 8/75 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).
Nervous system disorders HEADACHE	6.1% 9/147 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).	2.7% 2/75 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).
Psychiatric disorders DEPRESSION	6.1% 9/147 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).	4.0% 3/75 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).
Psychiatric disorders INSOMNIA	12.2% 18/147 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).	12.0% 9/75 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).
Renal and urinary disorders LEUKOCYTURIA	2.7% 4/147 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).	5.3% 4/75 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).
Skin and subcutaneous tissue disorders DERMATITIS ACNEIFORM	4.8% 7/147 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).	8.0% 6/75 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).
Vascular disorders HYPERTENSION	14.3% 21/147 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).	4.0% 3/75 • Up to 38 weeks Adverse events will be assessed at each participant visit. Treatment-emergent adverse events are reported in these tables. The adverse events were collected during the treatment period (up to 30 weeks) and in the follow-up period (up to 8 weeks) for participants who did not roll over to the OLE study (ARGX-113-1905).