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TerminatedNCT04598477ADDRESS+Updated Mar 30, 2025Results posted

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

A Phase 3 interventional study of efgartigimod PH20 SC and prednisone in Pemphigus Vulgaris and Pemphigus Foliaceus, sponsored by argenx. Terminated at 127 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-30.

Sponsored by argenx · Phase 3, Interventional, and Treatment

Why this study was terminated
Based on the lack of observed efficacy in the primary study ARGX-113-1904, the sponsor decided to discontinue the open-label extension study.
Phase
Phase 3
Study type
Interventional
Enrollment
183
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This was a prospective, multicenter, open label extension (OLE) trial on the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK and PD of efgartigimod PH20 SC in adult PV or PF participants, who participated in antecedent trial ARGX-113-1904. This trial provided extension of efgartigimod PH20 SC treatment and retreatment options for participants who had been randomized to efgartigimod PH20 SC treatment arm in the trial ARGX-113-1904, and first treatment of efgartigimod PH20 SC and retreatment options for participants who had been randomized to the placebo arm in trial ARGX-113-1904. The participants could also receive concomitant prednisone therapy. Investigators could increase or decrease the prednisone dose based on protocol-specified criteria.

Trial ARGX-113-1905 evaluated the ability to (further) taper prednisone therapy and achieve Clinical Remission (CR) off therapy (CRoff), the ability to achieve CR and CR on minimal therapy (CRmin) for participants who had not yet achieved CR or CRmin, and the ability to treat flare; it also assessed patient outcome measures and the safety, PD, PK and immunogenicity of efgartigimod PH20 SC over the duration of trial.

Study duration: Up to 60 weeks for participants who receive IMP administration up to 52 weeks and with a follow-up period of 8 weeks after the last IMP administration

02

Conditions studied

  • Pemphigus Vulgaris
  • Pemphigus Foliaceus

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Ability to understand the requirements of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits).
  2. The participant participated in trial ARGX-113-1904 and completed the study or has the defined criteria for rollover.

  3. Contraceptive use by men and women should be consistent with local regulations regarding the methods for contraception for those participating in clinical trials and:

    1. Male participants:

      Male participants must agree to use an acceptable method of contraception as described in the protocol, from signing the ICF until the last dose of the study drug.

    2. Female participants

Women of childbearing potential (WOCBP) must:

  • have a negative urine pregnancy test at baseline before the IMP can be administered,
  • agree to use a highly effective or acceptable contraception method (as described in the protocol), which should be maintained at minimum until after the last dose of IMP

Exclusion criteria

Exclusion Criteria:

  1. Pregnant and lactating women and those intending to become pregnant during the trial.
  2. Participants with clinical evidence of other significant serious disease or participants who recently underwent or have planned a major surgery during the period of the trial, or any other condition in the opinion of the investigator, that could confound the results of the trial or put the participant at undue risk.
  3. Known hypersensitivity to any of the components of the administered treatments.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
183 participants (actual)

Study arms

  • Experimental
    efgartigimod PH20 SC

    patients receiving efgartigimod PH20 SC on top of prednisone

    Biological: efgartigimod PH20 SC · Drug: prednisone

Interventions

  • Biologicalefgartigimod PH20 SC

    Subcutaneous injection of efgartigimod using rHuPH20 (PH20) as a permeation enhancer

  • Drugprednisone

    Oral prednisone tablets

05

What researchers measure

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events (TEAE), Adverse Events of Special Interest (AESI), and Serious Adverse Events (SAE)

    Incidence rates were calculated as 100 × n/PYFU. PYFU=participant-years of follow-up. The safety data sets includes participants with pemphigus vulgaris (PV) and pemphigus foliaceus (PF).

    Time frame: Up to 60 weeks

Secondary outcomes

  1. Proportion of Participants With Pemphigus Vulgaris (PV) and Pemphigus Foliaceus (PF) Who Achieve CRmin

    CRmin 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.

    Time frame: Up to 60 weeks

  2. Proportion of Participants With Pemphigus Vulgaris (PV) Who Achieve CRmin

    CRmin (complete clinical remission on minimal prednisone therapy) 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.

    Time frame: Up to 60 weeks

  3. Time to DC in Participants With PV and PF

    Disease Control (DC) defined as absence of new lesions and the start of healing of established lesions

    Time frame: Up to 52 weeks

  4. Time to CR in Participants With PV and PF

    CR (Complete clinical remission) defined as the absence of new lesions and complete healing of established lesions

    Time frame: Up to 52 weeks

  5. Time to CRmin in Participants With PV and PF

    CRmin 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.

    Time frame: Up to 52 weeks

  6. Time to CRoff in Participants With PV and PF

    Complete remission off therapy (CRoff) is defined as the absence of new and established lesions completely healed while the patient is receiving no prednisone therapy for at least 8 weeks.

    Time frame: Up to 52 weeks

  7. Time to Flare After CRmin in Participants With PV and PF

    CRmin defined as 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.

    Time frame: Up to 52 weeks

  8. Rate of Treatment Failure in Participants With PV and PF

    The absence of DC with oral prednisone 1.5 mg/kg/day for a minimum of 3 weeks, or absence of DC due to prednisone-related SAE, or flare before CRmin resulting in withdrawal of the participant.

    Time frame: Up to 52 weeks

  9. Number of Flares in Participants With PV and PF

    A flare is defined as the appearance of 3 or more new lesions in a 4-week period that do not heal spontaneously within 1 week or the extension, of established lesions in a participant who had achieved DC.

    Time frame: Up to 60 weeks

  10. Normalized Cumulative Prednisone Dose in Participants With PV and PF

    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

    Time frame: Up to 60 weeks

06

Results

Posted Mar 30, 2025
Limitations and caveats
Study was terminated prematurely by the Sponsor.

Participant flow

This study was terminated early based on the lack of observed efficacy in antecedent ARGX-113-1904. A total of 183 participants rolled over from ARGX-113-1904. Of these, 57 participants had a CRmin status (complete remission on minimal prednisone therapy) at rollover of which 34 participants did not receive efgartigimod PH20 SC in this ARGX-113-1905 study.

Participant flow — Overall Study
MilestoneEfgartigimod-efgartigimod PH20 SCPlacebo-efgartigimod PH20 SC
Started12360
Completed6423
Not completed5937
Withdrew: Adverse event20
Withdrew: Death01
Withdrew: Lost to follow-up10
Withdrew: Physician decision72
Withdrew: Pregnancy01
Withdrew: Requires prohibited medication01
Withdrew: Study terminated by sponsor1812
Withdrew: Withdrawal by subject1612
Withdrew: Other158

Outcome measures

PrimaryIncidence of Treatment-Emergent Adverse Events (TEAE), Adverse Events of Special Interest (AESI), and Serious Adverse Events (SAE)

Incidence rates were calculated as 100 × n/PYFU. PYFU=participant-years of follow-up. The safety data sets includes participants with pemphigus vulgaris (PV) and pemphigus foliaceus (PF).

Time frame:
Up to 60 weeks
Reported as:
Number · number of events x 100/PYFU
Incidence of Treatment-Emergent Adverse Events (TEAE), Adverse Events of Special Interest (AESI), and Serious Adverse Events (SAE)
number of events x 100/PYFUEfgartigimod-efgartigimod PH20 SCPlacebo-efgartigimod PH20 SC
Treatment-Emergent Adverse Event (TEAE)116.4113.0
Adverse Event of Special Interest (AESI)72.069.3
Serious Adverse Event (SAE)24.514.6
SecondaryProportion of Participants With Pemphigus Vulgaris (PV) and Pemphigus Foliaceus (PF) Who Achieve CRmin

CRmin 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.

Time frame:
Up to 60 weeks
Reported as:
Count of participants · Participants
Proportion of Participants With Pemphigus Vulgaris (PV) and Pemphigus Foliaceus (PF) Who Achieve CRmin
ParticipantsEfgartigimod-efgartigimod PH20 SCPlacebo-efgartigimod PH20 SC
Proportion of Participants With Pemphigus Vulgaris (PV) and Pemphigus Foliaceus (PF) Who Achieve CRmin5526
SecondaryProportion of Participants With Pemphigus Vulgaris (PV) Who Achieve CRmin

CRmin (complete clinical remission on minimal prednisone therapy) 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.

Time frame:
Up to 60 weeks
Reported as:
Count of participants · Participants
Proportion of Participants With Pemphigus Vulgaris (PV) Who Achieve CRmin
ParticipantsEfgartigimod-efgartigimod PH20 SCPlacebo-efgartigimod PH20 SC
Proportion of Participants With Pemphigus Vulgaris (PV) Who Achieve CRmin4722
SecondaryTime to DC in Participants With PV and PF

Disease Control (DC) defined as absence of new lesions and the start of healing of established lesions

Time frame:
Up to 52 weeks
Reported as:
Median · days
Time to DC in Participants With PV and PF
daysEfgartigimod-efgartigimod PH20 SCPlacebo-efgartigimod PH20 SC
Time to DC in Participants With PV and PF8.5 (8.0 to 15.0)15.0 (8.0 to 22.0)
SecondaryTime to CR in Participants With PV and PF

CR (Complete clinical remission) defined as the absence of new lesions and complete healing of established lesions

Time frame:
Up to 52 weeks
Reported as:
Median · Days
Time to CR in Participants With PV and PF
DaysEfgartigimod-efgartigimod PH20 SCPlacebo-efgartigimod PH20 SC
Time to CR in Participants With PV and PF66.0 (43.0 to 182.0)71.0 (41.0 to 100.0)
SecondaryTime to CRmin in Participants With PV and PF

CRmin 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.

Time frame:
Up to 52 weeks
Reported as:
Median · days
Time to CRmin in Participants With PV and PF
daysEfgartigimod-efgartigimod PH20 SCPlacebo-efgartigimod PH20 SC
Time to CRmin in Participants With PV and PF229.0 (161.0 to NA)169.0 (141.0 to 322.0)
SecondaryTime to CRoff in Participants With PV and PF

Complete remission off therapy (CRoff) is defined as the absence of new and established lesions completely healed while the patient is receiving no prednisone therapy for at least 8 weeks.

Time frame:
Up to 52 weeks
Reported as:
Median · days
Time to CRoff in Participants With PV and PF
daysEfgartigimod-efgartigimod PH20 SCPlacebo-efgartigimod PH20 SC
Time to CRoff in Participants With PV and PFNA (NA to NA)NA (NA to NA)
SecondaryTime to Flare After CRmin in Participants With PV and PF

CRmin defined as 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.

Time frame:
Up to 52 weeks
Reported as:
Median · days
Time to Flare After CRmin in Participants With PV and PF
daysEfgartigimod-efgartigimod PH20 SCPlacebo-efgartigimod PH20 SC
Time to Flare After CRmin in Participants With PV and PF339.0 (223.0 to NA)168.0 (64.0 to NA)
SecondaryRate of Treatment Failure in Participants With PV and PF

The absence of DC with oral prednisone 1.5 mg/kg/day for a minimum of 3 weeks, or absence of DC due to prednisone-related SAE, or flare before CRmin resulting in withdrawal of the participant.

Time frame:
Up to 52 weeks
Reported as:
Count of participants · Participants
Rate of Treatment Failure in Participants With PV and PF
ParticipantsEfgartigimod-efgartigimod PH20 SCPlacebo-efgartigimod PH20 SC
Rate of Treatment Failure in Participants With PV and PF31
SecondaryNumber of Flares in Participants With PV and PF

A flare is defined as the appearance of 3 or more new lesions in a 4-week period that do not heal spontaneously within 1 week or the extension, of established lesions in a participant who had achieved DC.

Time frame:
Up to 60 weeks
Reported as:
Mean · Flares
Number of Flares in Participants With PV and PF
FlaresEfgartigimod-efgartigimod PH20 SCPlacebo-efgartigimod PH20 SC
Number of Flares in Participants With PV and PF0.8 ± 1.030.7 ± 0.79
SecondaryNormalized Cumulative Prednisone Dose in Participants With PV and PF

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

Time frame:
Up to 60 weeks
Reported as:
Mean · mg/kg/day
Normalized Cumulative Prednisone Dose in Participants With PV and PF
mg/kg/dayEfgartigimod-efgartigimod PH20 SCPlacebo-efgartigimod PH20 SC
Normalized Cumulative Prednisone Dose in Participants With PV and PF0.212 ± 0.20180.241 ± 0.2401

Adverse events

Collected over Up to 60 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Efgartigimod-efgartigimod PH20 SC0/101 (0%)16/101 (15.8%)46/101 (45.5%)
Placebo-efgartigimod PH20 SC1/48 (2.1%)4/48 (8.3%)19/48 (39.6%)
Most frequent serious events
Showing 10 of 25
Most frequent serious events
EventEfgartigimod-efgartigimod PH20 SCPlacebo-efgartigimod PH20 SC
PEMPHIGUSSkin and subcutaneous tissue disorders3/1011/48
LUNG ABSCESSInfections and infestations0/1011/48
SEPSISInfections and infestations0/1011/48
SKIN INFECTIONInfections and infestations0/1011/48
PATELLA FRACTUREInjury, poisoning and procedural complications0/1011/48
MUSCULOSKELETAL PAINMusculoskeletal and connective tissue disorders0/1011/48
SHOCK HAEMORRHAGICVascular disorders0/1011/48
GASTRITIS EROSIVEGastrointestinal disorders2/1010/48
DISEASE PROGRESSIONGeneral disorders2/1010/48
COVID-19Infections and infestations2/1010/48
Most frequent other events
Showing 10 of 17
Most frequent other events
EventEfgartigimod-efgartigimod PH20 SCPlacebo-efgartigimod PH20 SC
COVID-19Infections and infestations12/1015/48
HEADACHENervous system disorders3/1014/48
BLOOD LACTATE DEHYDROGENASE INCREASEDInvestigations7/1011/48
INCREASED TENDENCY TO BRUISEBlood and lymphatic system disorders0/1013/48
TACHYCARDIACardiac disorders1/1013/48
INJECTION SITE ERYTHEMAGeneral disorders4/1013/48
MYOPATHYMusculoskeletal and connective tissue disorders2/1013/48
HAEMATURIARenal and urinary disorders2/1013/48
PRURITUSSkin and subcutaneous tissue disorders2/1013/48
ORAL CANDIDIASISInfections and infestations6/1010/48

Baseline characteristics

Roll-over set

Age, Continuous
Age, Continuous(years)Efgartigimod-efgartigimod PH20 SCPlacebo-efgartigimod PH20 SCTotal
Mean50.1 ± 11.4052.4 ± 13.0250.8 ± 11.97
Sex: Female, Male
Sex: Female, Male(Participants)Efgartigimod-efgartigimod PH20 SCPlacebo-efgartigimod PH20 SCTotal
Female613293
Male622890
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Efgartigimod-efgartigimod PH20 SCPlacebo-efgartigimod PH20 SCTotal
Asian40949
Black or African American123
White8147128
Other123
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Efgartigimod-efgartigimod PH20 SCPlacebo-efgartigimod PH20 SCTotal
Hispanic or Latino347
Not Hispanic or Latino12056176
07

Study locations

127 sites
  • Investigator site 115 - US0010086
    Birmingham, Alabama 35233, United States
  • Investigator site 89 - US0010091
    Scottsdale, Arizona 85259, United States
  • Investigator site 124 - US0010092
    Redwood City, California 94063, United States
  • Investigator site 1 - US0010087
    Boca Raton, Florida 33428, United States
  • Investigator site 90 - US0010117
    Miami, Florida 33173, United States
  • Investigator site 91 - US0010109
    Orlando, Florida 32827, United States
  • Investigator site 126 - US0010090
    Minneapolis, Minnesota 55455, United States
  • Investigator site 111 - US0010098
    Saint Louis, Missouri 63110, United States
  • Investigator site 10 - US0010088
    Buffalo, New York 14203-1070, United States
  • Investigator site 76 - US0010096
    Durham, North Carolina 27710, United States
  • Investigator site 30 - US0010094
    Cleveland, Ohio 44106-1716, United States
  • Investigator site 84 - US0010089
    Philadelphia, Pennsylvania 19104, United States
  • Investigator site 103 - US0010097
    Philadelphia, Pennsylvania 19140, United States
  • Investigator site 125 - US0010107
    Dallas, Texas 75246, United States
  • Investigator site 87 - US0010084
    Dripping Springs, Texas 78620, United States
  • Investigator site 88 - US0010114
    Houston, Texas 77008, United States
  • Investigator site 44 - US0010106
    Norfolk, Virginia 23502, United States
  • Investigator site 15 - AU0610006
    Sydney, New South Wales 2217, Australia
  • Investigator site 11 - AU0610007
    Parkville, Victoria 3050, Australia
  • Investigator site 92 - AU0610013
    Melbourne, 3065, Australia
  • Investigator site 17 - BG3590012
    Pleven, 5800, Bulgaria
  • Investigator site 18 - BG3590013
    Plovdiv, 4000, Bulgaria
  • Investigator site 2 - BG3590010
    Sofia, 1431, Bulgaria
  • Investigator site 16 - BG3590009
    Sofia, 1510, Bulgaria
  • Investigator site 3 - BG3590011
    Sofia, 1606, Bulgaria
  • Investigator site 101 - CN0860017
    Beijing, 100034, China
  • Investigator site 107 - CN0860018
    Chengdu, 610000, China
  • Investigator site 118 - CH0860027
    Chongqing, 400042, China
  • Investigator site 120 - CH0860023
    Fuzhou, 35005, China
  • Investigator site 119 - CH0860022
    Guangzhou, 510000, China
  • Investigator site 116 - CH0860053
    Guangzhou, 51000, China
  • Investigator site 100 - CN0860021
    Guanzhou, 510000, China
  • Investigator site 113 - CN0860024
    Nanjing, 210042, China
  • Investigator site 102 - CN0860020
    Shanghai, 200025, China
  • Investigator site 99 - CN0860016
    Shanghai, 200040, China
  • Investigator site 112 - CN0860019
    Wuhan, 430022, China
  • Investigator site 121 - CH0860025
    Wuhan, 430022, China
  • Investigator site 117 - CH0860026
    Zhengzhou, 450008, China
  • Investigator site 77 - FR0330028
    Bobigny, 93000, France
  • Investigator site 60 - FR0330027
    La Tronche, 38700, France
  • Investigator site 108 - FR0330029
    Rouen, 76031, France
  • Investigator site 51 - FR0330026
    Saint-Étienne, 42055, France
  • Investigator site 78 - GE9950014
    Tbilisi, 0159, Georgia
  • Investigator site 127 - GE9950030
    Tbilisi, 0160, Georgia
  • Investigator site 32 - GE9950013
    Tbilisi, 0162, Georgia
  • Investigator site 31 - GE9950015
    Tbilisi, 0179, Georgia
  • Investigator site 45 - DE0490029
    Berlin, 10117, Germany
  • Investigator site 34 - DE0490030
    Dresden, 01307, Germany
  • Investigator site 33 - DE0490024
    Frankfurt am main, 60590, Germany
  • Investigator site 53 - DE0490023
    Freiburg, 79104, Germany
  • Investigator site 35 - DE0490028
    Kiel, 24105, Germany
  • Investigator site 20 - DE0490002
    Lübeck, 23538, Germany
  • Investigator site 52 - DE0490001
    Marburg, 35043, Germany
  • Investigator site 19 - DE0490025
    Tübingen, 72076, Germany
  • Investigator site 93 - DE0490027
    Ulm, 89081, Germany
  • Investigator site 4 - DE0490026
    Würzburg, 97080, Germany
  • Investigator site 21 - GR030004
    Athens, 11525, Greece
  • Investigator site 37 - GR030006
    Athens, 16121, Greece
  • Investigator site 54 - GR0300001
    Athens, 16121, Greece
  • Investigator site 22 - GR030003
    Chaïdári, 12462, Greece
  • Investigator site 36 - GR0300002
    Thessaloníki, 54643, Greece
  • Investigator site 23 - GR030005
    Thessaloníki, 56429, Greece
  • Investigator site 6 - HU0360003
    Debrecen, 4032, Hungary
  • Investigator site 5 - HU0360001
    Pécs, 7632, Hungary
  • Investigator site 24 - HU0360002
    Szeged, 6720, Hungary
  • Investigator site 65 - IN0910002
    Ahmedabad, 380016, India
  • Investigator site 94 - IN0910001
    Chandigarh, 160012, India
  • Investigator site 79 - IN0910004
    Lucknow, 226005, India
  • Investigator site 80 - IN0910003
    Nagpur, 440003, India
  • Investigator site 85 - IL9720002
    Tel Aviv, 64239, Israel
  • Investigator site 95 - IT0390039
    Catania, 95123, Italy
  • Investigator site 38 - IT0390031
    Firenze, 50125, Italy
  • Investigator site 81 - IT0390030
    Genova, 16132, Italy
  • Investigator site 55 - IT0390038
    Perugia, 06129, Italy
  • Investigator site 12 - IT0390006
    Roma, 00167, Italy
  • Investigator site 25 - IT-0390005
    Roma, 00168, Italy
  • Investigator site 61 - IT0390040
    Siena, 53100, Italy
  • Investigator site 82 - JP0810046
    Aichi, 480-1195, Japan
  • Investigator site 68 - JP0810040
    Hiroshima, 734-8551, Japan
  • Investigator site 69 - JP0810050
    Kurume, 830-001, Japan
  • Investigator site 66 - JP0810042
    Kōfu, 400-8506, Japan
  • Investigator site 73 - JP0810047
    Okayama, 700-8558, Japan
  • Investigator site 70 - JP0810041
    Okayama, 701-0192, Japan
  • Investigator site 71 - JP0810049
    Osaka, 545-8586, Japan
  • Investigator site 72 - JP0810045
    Sapporo, 060-8648, Japan
  • Investigator site 114 - JP0810067
    Sendai, 980-8574, Japan
  • Investigator site 67 - JP0810043
    Tokyo, 113-8431, Japan
  • Investigator site 27 - PL0480027
    Katowice, 40-081, Poland
  • Investigator site 86 - PL0480036
    Poznań, 60-369, Poland
  • Investigator site 28 - PL0480025
    Rzeszów, 35-055, Poland
  • Investigator site 26 - PL0480028
    Wrocław, 50-566, Poland
  • Investigator site 56 - PL0480032
    Łódź, 90-647, Poland
  • Investigator site 97 - RO0400013
    Bucharest, 011216, Romania
  • Investigator 96 - RO0400014
    Cluj-Napoca, 400006, Romania
  • Investigator site 98 - RO0400015
    Iaşi, 700111, Romania
  • Investigator site 40 - RU0070035
    Chelyabinsk, 454092, Russian Federation
  • Investigator site 41 - RU0070033
    Ekaterinburg, 620076, Russian Federation
  • Investigator site 48 - RU0070029
    Kazan, 420111, Russian Federation
  • Investigator site 49 - RU0070030
    Krasnodar, 350020, Russian Federation
  • Investigator site 39 - RU0070032
    Rostov-on-Don, 344002, Russian Federation

Showing the first 100 of 127 sites across 21 countries.

08

References and documents

Study documents

  • Study protocol · Sep 5, 2022
  • Statistical analysis plan · Apr 26, 2024

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT04598477
Lead sponsor
argenx
Responsible party
Sponsor
First posted
Oct 22, 2020
Start date
Jul 15, 2021
Primary completion
Mar 25, 2024
Completion
Mar 25, 2024
Results posted
Mar 30, 2025
Last update
Mar 30, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
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