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A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid (BALLAD)

Primary Purpose

Bullous Pemphigoid

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
efgartigimod PH20 SC
placebo
Prednisone
Sponsored by
argenx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bullous Pemphigoid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The participant is willing and able to do the following:

    1. understand the requirements of the study
    2. provide written informed consent
    3. comply with the study protocol procedures.
  • The participant is male or female and has reached the age of consent at the time of signing the informed consent form (ICF).
  • Participants have clinical signs of BP.

  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and:

    1. Male participants:

      * Must agree to use an acceptable method of contraception from the time that the ICF is signed until the date of their last dose of IMP.

    2. Female participants:

      • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before study intervention can be administered.
      • WOCBP must agree to use at least one of the contraception methods identified in the protocol from the time that the ICF is signed until the date of their last dose of IMP.

The full list of inclusion criteria can be found in the protocol.

Exclusion Criteria:

  • Other forms of pemphigoid or other autoimmune bullous diseases (AIBDs).
  • Received unstable dose of treatments known to cause or exacerbate BP for at least 4 weeks prior to the baseline visit
  • Use of BP treatments other than oral corticosteroids (OCS), topical corticosteroids (TCS), conventional immunosuppressants or dapsone.
  • Known contraindication to OCS therapy
  • Active or chronic infection at screening
  • Positive COVID-19 test result at screening (testing performed if required per local regulations).

  • History of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of the IMP. Participants with the following cancers can be included at any time, provided they are adequately treated prior to their participation in the study:

    • Basal cell or squamous cell skin cancer
    • Carcinoma in situ of the cervix
    • Carcinoma in situ of the breast
    • Incidental histological finding of prostate cancer
  • Clinical evidence of other significant serious diseases, have had a recent surgery, or who have any other condition that, in the opinion of the investigator, could confound the results of the study or put the patient at undue risk
  • Use of an investigational product within 3 months before the first dose of IMP
  • Previously participated in a clinical study with efgartigimod
  • Known hypersensitivity to any of the components of the administered treatments

  • Positive serum test at screening for an active infection:

    • HBV
    • HCV
    • HIV
  • Current or history (ie, within 12 months of screening) of alcohol, drug, or medication abuse
  • Pregnant or lactating females and those who intend to become pregnant during the study

The full list of exclusion criteria can be found in the protocol.

Sites / Locations

  • Investigator site 74 - US0010178Recruiting
  • Investigator site 6 - US0010138Recruiting
  • Investigator site 121 - US0010092
  • Investigator site 72 - US0010186Recruiting
  • Investigator site 10 - US0010153Recruiting
  • Investigator site 2 - US0010087Recruiting
  • Investigator site 21 - US0010152Recruiting
  • Investigator site 1 - US0010017Recruiting
  • Investigator site 13 - US0010155Recruiting
  • Investigator site 35 - US0010156
  • Investigator site 50 - US0010149Recruiting
  • Investigator site 115 - US0010157Recruiting
  • Investigator site 73 - US0010098Recruiting
  • Investigator site 85 - US0010159Recruiting
  • Investigator site 5 - US0010088Recruiting
  • Investigator site 93 - US0010169Recruiting
  • Investigator site 4 - US0010137Recruiting
  • Investigator site 25 - US0010158Recruiting
  • Investigator site 34 - US0010182Recruiting
  • Investigator site 92 - US0010150Recruiting
  • Investigator site 3 - US0010151Recruiting
  • Investigator site 36 - AU0610013Recruiting
  • Investigator site 27 - AU0610006Recruiting
  • Investigator site AU0610019
  • Investigator site 28 - BG3590018Recruiting
  • Investigator site 14 - BG3590010Recruiting
  • Investigator site 15 - BG3590020Recruiting
  • Investigator site 111 - CN0860064Recruiting
  • Investigator site 91 - CN0860017Recruiting
  • Investigator site 95 - CN0860018Recruiting
  • Investigator site 116 - CN0860027
  • Investigator site 108 - CN0860023Recruiting
  • Investigator site 107 - CN0860021Recruiting
  • Investigator site 110 - CN0860053Recruiting
  • Investigator site 124 - CN0860098
  • Investigator site 94 - CN0860066Recruiting
  • Investigator site 123 - CN0860095
  • Investigator site 109 - CN0860025Recruiting
  • Investigator site CN0860026
  • Investigator site 122 - CN0860065
  • Investigator site 22 - HR3850003Recruiting
  • Investigator site 16 - HR3850002Recruiting
  • Investigator site 37 - HR3850001Recruiting
  • Investigator site 97 - CZ4200015Recruiting
  • Investigator site 118 - CZ4200016
  • Investigator site 117 - CZ4200013
  • Investigator site 96 - CZ4200012Recruiting
  • Investigator site 38 - FR0330040Recruiting
  • Investigator site 29 - FR0330029Recruiting
  • Investigator site 46 - DE0490039Recruiting
  • Investigator site 54 - DE0490030Recruiting
  • Investigator site 80 - DE0490041Recruiting
  • Investigator site 57 - DE0490046Recruiting
  • Investigator site 51 - DE0490008Recruiting
  • Investigator site 52 - DE0490024Recruiting
  • Investigator site 53 - DE0490023Recruiting
  • Investigator site 56 - DE0490028Recruiting
  • Investigator site 45 - DE0490001Recruiting
  • Investigator site 75 - DE0490047Recruiting
  • Investigator site 55 - DE0490026Recruiting
  • Investigator site 60 - GE0300004Recruiting
  • Investigator site 62 - GE0300006Recruiting
  • Investigator site 58 - GR0300001Recruiting
  • Investigator site 76 - GR030003Recruiting
  • Investigator site 61 - GE0300002Recruiting
  • Investigator site 59 - GR0300005Recruiting
  • Investigator site 26 - HU0360023Recruiting
  • Investigator site 11 - HU0360003Recruiting
  • Investigator site 7 - HU0360008Recruiting
  • Investigator site 39 - IL9720003Recruiting
  • Investigator site 63 - IL9720018Recruiting
  • Investigator site 41 - IL9720001Recruiting
  • Investigator site 40 - IL9720002Recruiting
  • Investigator site 65 - IT0390055Recruiting
  • Investigator site 43 - IT0390060Recruiting
  • Investigator site 78 - IT0390039Recruiting
  • Investigator site 47 - IT0390031Recruiting
  • Investigator site 86 - IT0390067Recruiting
  • Investigator site 81 - IT0390030Recruiting
  • Investigator site 77 - IT0390062Recruiting
  • Investigator site 119 - IT0390066
  • Investigator site 64 - IT0390061Recruiting
  • Investigator site 23 - IT0390006Recruiting
  • Investigator site 42 - IT0390005Recruiting
  • Investigator site 30 - IT0390040Recruiting
  • Investigator site 103 - JP0810070Recruiting
  • Investigator site 99 - JP0810050Recruiting
  • Investigator site 104 - JP0810071Recruiting
  • Investigator site 100 - JP0810046Recruiting
  • Investigator site 101 - JP0810049Recruiting
  • Investigator site 112 - JP0810045Recruiting
  • Investigator site 105 - JP0810067Recruiting
  • Investigator site 98 - JP0810043Recruiting
  • Investigator site 106 - JP0810068Recruiting
  • Investigator site 102 - JP0810069Recruiting
  • Investigator site 87 - LV3710005Recruiting
  • Investigator site 82 - LV3710003Recruiting
  • Investigator site 88 - LV3710004Recruiting
  • Investigator site 66 - NL0310015Recruiting
  • Investigator site 79 - PL0480025Recruiting
  • Investigator site 83 - PL0480050Recruiting
  • Investigator site 18 - PL0480048Recruiting
  • Investigator site 19 - PL0480046Recruiting
  • Investigator site 17 - PL0480047Recruiting
  • Investigator site 90 - RO0400014Recruiting
  • Investigator site 89 - RO0400015Recruiting
  • Investigator 68 - RS381011Recruiting
  • Investigator site 84 - RS3810010Recruiting
  • Investigator site 67 - RS3810012Recruiting
  • Investigator site 69 - RS3810009Recruiting
  • Investigator site 113 - SK4210002Recruiting
  • Investigator site 120 - SK4210004
  • Investigator site 114 - SK4210003Recruiting
  • Investigator site 32 - ES0340050Recruiting
  • Investigator 24 - ES0340051Recruiting
  • Investigator site 8 - ES0340053Recruiting
  • Investigator site 12 - ES0340025Recruiting
  • Investigator 20 - ES0340029Recruiting
  • Investigator site 49 - ES0340058Recruiting
  • Investigator site 48 - ES0340059
  • Investigator site 31 - ES0340057Recruiting
  • Investigator site 9 - ES0340052Recruiting
  • Investigator site 70 - ES0340061Recruiting
  • Investigator site 33 - UK0440022Recruiting
  • Investigator site 71 - UK0440036Recruiting
  • Investigator site 44 - UK0440037Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

efgartigimod PH20 SC

placebo PH20 SC

Arm Description

participants receiving efgartigimod PH20 SC on top of Prednisone

participants receiving placebo PH20 SC on top of Prednisone

Outcomes

Primary Outcome Measures

Proportion of participants who are in complete remission (CR) while receiving efgartigimod PH20 SC or placebo and have been off oral corticosteroid (OCS) therapy for ≥8 weeks at week 36

Secondary Outcome Measures

Cumulative dose of oral corticosteroid (OCS) from baseline to week 36
Proportion of participants who achieve an Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) score of 0 while receiving efgartigimod PH20 SC or placebo and have been off oral corticosteroid (OCS) therapy for ≥8 weeks at week 36
Proportion of participants who achieve an Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) score of 0 or 1 while receiving efgartigimod PH20 SC or placebo and have been off oral corticosteroid (OCS) therapy for ≥8 weeks at week 36
Proportion of participants who achieve an Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) score of 0 or 1 while receiving efgartigimod PH20 SC or placebo at any time through week 36
Changes from baseline in the Bullous Pemphigoid Disease Area Index (BPDAI) activity score
Proportion of participants who are in complete remission (CR) while receiving efgartigimod PH20 SC or placebo and have been receiving minimal oral corticosteroid (OCS) therapy for ≥8 weeks at week 36
Minimal oral corticosteroid (OCS) therapy is defined as ≤0.1 mg/kg/day of prednisone (or an equivalent dose of another OCS).
Time to achieve control of disease activity (CDA)
Time to achieve complete remission (CR)
Time to achieve complete remission (CR) while on minimal oral corticosteroid (OCS) therapy for ≥8 weeks
Time to achieve complete remission (CR)/partial remission (PR) while off oral corticosteroid (OCS) therapy for ≥8 weeks
Time to achieve complete remission (CR) while off oral corticosteroid (OCS) therapy for ≥8 weeks
Time to achieve relapse
Cumulative oral corticosteroid (OCS) dose for the participant at the time points when they exhibit control of disease activity (CDA)
Cumulative oral corticosteroid (OCS) dose for the participant at the time points when they exhibit complete remission (CR)
Cumulative oral corticosteroid (OCS) dose for the participant at the time points when they exhibit complete remission (CR) while on minimal oral corticosteroid (OCS) therapy for ≥8 weeks
Cumulative oral corticosteroid (OCS) dose for the participant at the time points when they exhibit complete remission (CR)/partial remission (PR) while off oral corticosteroid (OCS) therapy for ≥8 weeks
Cumulative oral corticosteroid (OCS) dose for the participant at the time points when they exhibit complete remission (CR) while off oral corticosteroid (OCS) therapy for ≥8 weeks
Cumulative oral corticosteroid (OCS) dose for the participant at the time points when they exhibit relapse
Proportion of participants who receive rescue therapy before week 36
Proportion of participants who achieve control of disease activity (CDA) while receiving efgartigimod PH20 SC or placebo and remain free of relapse through week 36
Changes from baseline in the 24-hour average itch score from the Itch Numerical Rating Scale (Itch NRS)
Changes from baseline in the 24-hour worst itch score from the Itch Numerical Rating Scale (Itch NRS)
Incidence of treatment emergent adverse events (TEAEs)
Severity of treatment emergent adverse events (TEAEs)
Incidence of adverse events of special interest (AESIs)
Severity of adverse events of special interest (AESIs)
Incidence of serious adverse events (SAEs)
Severity of serious adverse events (SAEs)
The Aggregate Improvement Score (AIS) from the Glucocorticoid Toxicity Index (GTI)
The Cumulative Worsening Score (CWS) from the Glucocorticoid Toxicity Index (GTI)
The Glucocorticoid Toxicity Index Specific List (GTI-SL)
EuroQol 5-Dimension 5-Level (EQ-5D-5L) scores over time
Dermatology Life Quality Index (DLQI) scores over time
Autoimmune Bullous Disease Quality of Life (ABQoL) scores over time
Efgartigimod serum concentrations
Percent change of total IgG serum levels from baseline over time
Percent change of Anti-BP180 and anti-BP230 antibodies from baseline over time
Incidence of Antidrug antibodies (ADA) against efgartigimod (in serum) and antibodies produced against rHuPH20 (in plasma)
Number of participants (or their caregivers) who complete the (self-)administration training at study sites
Percentage of participants (or their caregivers) who complete the (self-)administration training at study sites
Number of participants (or their caregivers) who are determined by site staff to be sufficiently competent in (self-)administering efgartigimod PH20 SC
Percentage of participants (or their caregivers) who are determined by site staff to be sufficiently competent in (self-)administering efgartigimod PH20 SC
Number of participants (or their caregivers) who successfully (self-)administer efgartigimod PH20 SC under site staff supervision
Percentage of participants (or their caregivers) who successfully (self-)administer efgartigimod PH20 SC under site staff supervision

Full Information

First Posted
February 14, 2022
Last Updated
October 24, 2023
Sponsor
argenx
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1. Study Identification

Unique Protocol Identification Number
NCT05267600
Brief Title
A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid (BALLAD)
Official Title
A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2022 (Actual)
Primary Completion Date
February 7, 2025 (Anticipated)
Study Completion Date
March 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
argenx

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
ARGX-113-2009 is an operationally seamless 2-part, phase 2/3, prospective, global, multicenter, randomized, double-blinded, placebo-controlled study to investigate the efficacy, safety, tolerability, immunogenicity, participant-reported outcome measures (including those assessing participant QoL), PK, and PD of efgartigimod PH20 SC administered via subcutaneous (SC) injection in adult participants with moderate to severe BP. This study intends to demonstrate that efgartigimod is an effective and safe treatment for BP, providing participants with control of disease activity (CDA) and eventually remission while reducing their cumulative exposure to OCS. study will consist of 2 parts: Part A of the study is a phase 2 evaluation that intends to provide proof of concept for the therapeutic activity of efgartigimod PH20 SC in participants with BP. Part B of the study is a phase 3 evaluation that intends to confirm the results obtained from part A in a separate, larger group of participants with BP. An interim analysis will be performed during part A (on data obtained through week 26 for all Part A participants) to assess the primary endpoint and several secondary endpoints, confirm the appropriate sample size for part B of the study, and determine whether the efficacy results observed through week 26 of part A warrant continued study of efgartigimod PH20 SC for the treatment of participants with BP (futility analysis). Other than differences in main goals, endpoints, and statistical analyses, parts A and B are identical in schedule, structure, assessments, and conduct.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bullous Pemphigoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
efgartigimod PH20 SC
Arm Type
Experimental
Arm Description
participants receiving efgartigimod PH20 SC on top of Prednisone
Arm Title
placebo PH20 SC
Arm Type
Placebo Comparator
Arm Description
participants receiving placebo PH20 SC on top of Prednisone
Intervention Type
Biological
Intervention Name(s)
efgartigimod PH20 SC
Intervention Description
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Subcutaneous injection of placebo coformulated with rHuPH20, a permeation enhancer
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Oral Prednisone
Primary Outcome Measure Information:
Title
Proportion of participants who are in complete remission (CR) while receiving efgartigimod PH20 SC or placebo and have been off oral corticosteroid (OCS) therapy for ≥8 weeks at week 36
Time Frame
at week 36
Secondary Outcome Measure Information:
Title
Cumulative dose of oral corticosteroid (OCS) from baseline to week 36
Time Frame
up to week 36
Title
Proportion of participants who achieve an Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) score of 0 while receiving efgartigimod PH20 SC or placebo and have been off oral corticosteroid (OCS) therapy for ≥8 weeks at week 36
Time Frame
at week 36
Title
Proportion of participants who achieve an Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) score of 0 or 1 while receiving efgartigimod PH20 SC or placebo and have been off oral corticosteroid (OCS) therapy for ≥8 weeks at week 36
Time Frame
at week 36
Title
Proportion of participants who achieve an Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) score of 0 or 1 while receiving efgartigimod PH20 SC or placebo at any time through week 36
Time Frame
up to week 36
Title
Changes from baseline in the Bullous Pemphigoid Disease Area Index (BPDAI) activity score
Time Frame
up to week 36
Title
Proportion of participants who are in complete remission (CR) while receiving efgartigimod PH20 SC or placebo and have been receiving minimal oral corticosteroid (OCS) therapy for ≥8 weeks at week 36
Description
Minimal oral corticosteroid (OCS) therapy is defined as ≤0.1 mg/kg/day of prednisone (or an equivalent dose of another OCS).
Time Frame
at week 36
Title
Time to achieve control of disease activity (CDA)
Time Frame
up to week 36
Title
Time to achieve complete remission (CR)
Time Frame
up to week 36
Title
Time to achieve complete remission (CR) while on minimal oral corticosteroid (OCS) therapy for ≥8 weeks
Time Frame
up to week 36
Title
Time to achieve complete remission (CR)/partial remission (PR) while off oral corticosteroid (OCS) therapy for ≥8 weeks
Time Frame
up to week 36
Title
Time to achieve complete remission (CR) while off oral corticosteroid (OCS) therapy for ≥8 weeks
Time Frame
up to week 36
Title
Time to achieve relapse
Time Frame
up to week 36
Title
Cumulative oral corticosteroid (OCS) dose for the participant at the time points when they exhibit control of disease activity (CDA)
Time Frame
up to week 36
Title
Cumulative oral corticosteroid (OCS) dose for the participant at the time points when they exhibit complete remission (CR)
Time Frame
up to week 36
Title
Cumulative oral corticosteroid (OCS) dose for the participant at the time points when they exhibit complete remission (CR) while on minimal oral corticosteroid (OCS) therapy for ≥8 weeks
Time Frame
up to week 36
Title
Cumulative oral corticosteroid (OCS) dose for the participant at the time points when they exhibit complete remission (CR)/partial remission (PR) while off oral corticosteroid (OCS) therapy for ≥8 weeks
Time Frame
up to week 36
Title
Cumulative oral corticosteroid (OCS) dose for the participant at the time points when they exhibit complete remission (CR) while off oral corticosteroid (OCS) therapy for ≥8 weeks
Time Frame
up to week 36
Title
Cumulative oral corticosteroid (OCS) dose for the participant at the time points when they exhibit relapse
Time Frame
up to week 36
Title
Proportion of participants who receive rescue therapy before week 36
Time Frame
at week 36
Title
Proportion of participants who achieve control of disease activity (CDA) while receiving efgartigimod PH20 SC or placebo and remain free of relapse through week 36
Time Frame
up to week 36
Title
Changes from baseline in the 24-hour average itch score from the Itch Numerical Rating Scale (Itch NRS)
Time Frame
up to week 36
Title
Changes from baseline in the 24-hour worst itch score from the Itch Numerical Rating Scale (Itch NRS)
Time Frame
up to week 36
Title
Incidence of treatment emergent adverse events (TEAEs)
Time Frame
up to 46 weeks
Title
Severity of treatment emergent adverse events (TEAEs)
Time Frame
up to 46 weeks
Title
Incidence of adverse events of special interest (AESIs)
Time Frame
up to 46 weeks
Title
Severity of adverse events of special interest (AESIs)
Time Frame
up to 46 weeks
Title
Incidence of serious adverse events (SAEs)
Time Frame
up to 46 weeks
Title
Severity of serious adverse events (SAEs)
Time Frame
up to 46 weeks
Title
The Aggregate Improvement Score (AIS) from the Glucocorticoid Toxicity Index (GTI)
Time Frame
up to week 36
Title
The Cumulative Worsening Score (CWS) from the Glucocorticoid Toxicity Index (GTI)
Time Frame
up to week 36
Title
The Glucocorticoid Toxicity Index Specific List (GTI-SL)
Time Frame
up to week 36
Title
EuroQol 5-Dimension 5-Level (EQ-5D-5L) scores over time
Time Frame
up to week 36
Title
Dermatology Life Quality Index (DLQI) scores over time
Time Frame
up to week 36
Title
Autoimmune Bullous Disease Quality of Life (ABQoL) scores over time
Time Frame
up to week 36
Title
Efgartigimod serum concentrations
Time Frame
up to week 43
Title
Percent change of total IgG serum levels from baseline over time
Time Frame
up to 46 weeks
Title
Percent change of Anti-BP180 and anti-BP230 antibodies from baseline over time
Time Frame
up to 46 weeks
Title
Incidence of Antidrug antibodies (ADA) against efgartigimod (in serum) and antibodies produced against rHuPH20 (in plasma)
Time Frame
up to 46 weeks
Title
Number of participants (or their caregivers) who complete the (self-)administration training at study sites
Time Frame
up to week 32
Title
Percentage of participants (or their caregivers) who complete the (self-)administration training at study sites
Time Frame
up to week 32
Title
Number of participants (or their caregivers) who are determined by site staff to be sufficiently competent in (self-)administering efgartigimod PH20 SC
Time Frame
up to week 32
Title
Percentage of participants (or their caregivers) who are determined by site staff to be sufficiently competent in (self-)administering efgartigimod PH20 SC
Time Frame
up to week 32
Title
Number of participants (or their caregivers) who successfully (self-)administer efgartigimod PH20 SC under site staff supervision
Time Frame
up to week 35
Title
Percentage of participants (or their caregivers) who successfully (self-)administer efgartigimod PH20 SC under site staff supervision
Time Frame
up to week 35

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The participant is willing and able to do the following: understand the requirements of the study provide written informed consent comply with the study protocol procedures. The participant is male or female and has reached the age of consent at the time of signing the informed consent form (ICF). Participants have clinical signs of BP. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and: Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before study intervention can be administered. The full list of inclusion criteria can be found in the protocol. Exclusion Criteria: Other forms of pemphigoid or other autoimmune bullous diseases (AIBDs). Received unstable dose of treatments known to cause or exacerbate BP for at least 4 weeks prior to the baseline visit Use of BP treatments other than oral corticosteroids (OCS), topical corticosteroids (TCS), conventional immunosuppressants or dapsone. Known contraindication to OCS therapy Active, chronic or latent infection at screening Positive COVID-19 test result at screening (testing performed if required per local regulations). History of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of the IMP. Participants with the following cancers can be included at any time, provided they are adequately treated prior to their participation in the study: Basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histological finding of prostate cancer Clinical evidence of other significant serious diseases, have had a recent surgery, or who have any other condition that, in the opinion of the investigator, could confound the results of the study or put the patient at undue risk or prevent participants from complying with protocol requirements Use of an investigational product within 3 months before the first dose of IMP Previously participated in a clinical study with efgartigimod or currently participating in another interventional clinical study Known hypersensitivity to any of the components of the administered treatments Positive serum test at screening for an active infection: HBV, HCV, HIV Current or history (ie, within 12 months of screening) of alcohol, drug, or medication abuse as assessed by the investigator Pregnant or lactating females and those who intend to become pregnant during the study Live or live-attenuated vaccine received <4 weeks before baseline visit The full list of exclusion criteria can be found in the protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Information:
Facility Name
Investigator site 74 - US0010178
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 6 - US0010138
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 121 - US0010092
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 72 - US0010186
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 10 - US0010153
City
Castle Rock
State/Province
Colorado
ZIP/Postal Code
80109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 2 - US0010087
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 21 - US0010152
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1 - US0010017
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 13 - US0010155
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 35 - US0010156
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Individual Site Status
Completed
Facility Name
Investigator site 50 - US0010149
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 115 - US0010157
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 73 - US0010098
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 85 - US0010159
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 5 - US0010088
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 93 - US0010169
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 4 - US0010137
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 25 - US0010158
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 34 - US0010182
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 92 - US0010150
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 3 - US0010151
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 36 - AU0610013
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 27 - AU0610006
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site AU0610019
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 28 - BG3590018
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 14 - BG3590010
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 15 - BG3590020
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 111 - CN0860064
City
Beijing
ZIP/Postal Code
100006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 91 - CN0860017
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 95 - CN0860018
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 116 - CN0860027
City
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 108 - CN0860023
City
Fujian
ZIP/Postal Code
350004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 107 - CN0860021
City
Guangzhou
ZIP/Postal Code
510091
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 110 - CN0860053
City
Guanzhou
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 124 - CN0860098
City
Nanchang
ZIP/Postal Code
330000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 94 - CN0860066
City
Nanyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 123 - CN0860095
City
Shanghai
ZIP/Postal Code
200435
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 109 - CN0860025
City
Wuhan
ZIP/Postal Code
430031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site CN0860026
City
Zhengzhou
ZIP/Postal Code
450003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 122 - CN0860065
City
Ürümqi
ZIP/Postal Code
830054
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 22 - HR3850003
City
Split
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 16 - HR3850002
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 37 - HR3850001
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 97 - CZ4200015
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 118 - CZ4200016
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 117 - CZ4200013
City
Plzen-Bory
ZIP/Postal Code
13, 301 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 96 - CZ4200012
City
Prague
ZIP/Postal Code
180 81
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 38 - FR0330040
City
Nice
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 29 - FR0330029
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 46 - DE0490039
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 54 - DE0490030
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 80 - DE0490041
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 57 - DE0490046
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 51 - DE0490008
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 52 - DE0490024
City
Frankfurt am main
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 53 - DE0490023
City
Freiburg
ZIP/Postal Code
79104
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 56 - DE0490028
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 45 - DE0490001
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 75 - DE0490047
City
München
ZIP/Postal Code
85006
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 55 - DE0490026
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 60 - GE0300004
City
Athens
ZIP/Postal Code
11525
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 62 - GE0300006
City
Athens
ZIP/Postal Code
11525
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 58 - GR0300001
City
Athens
ZIP/Postal Code
16121
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 76 - GR030003
City
Chaïdári
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 61 - GE0300002
City
Thessaloníki
ZIP/Postal Code
54643
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 59 - GR0300005
City
Thessaloníki
ZIP/Postal Code
56429
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 26 - HU0360023
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 11 - HU0360003
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 7 - HU0360008
City
Pécs
ZIP/Postal Code
7632
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 39 - IL9720003
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 63 - IL9720018
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 41 - IL9720001
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 40 - IL9720002
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 65 - IT0390055
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 43 - IT0390060
City
Brescia
ZIP/Postal Code
25132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 78 - IT0390039
City
Catania
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 47 - IT0390031
City
Firenze
ZIP/Postal Code
50122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 86 - IT0390067
City
Firenze
ZIP/Postal Code
50122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 81 - IT0390030
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 77 - IT0390062
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 119 - IT0390066
City
Parma
ZIP/Postal Code
43126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 64 - IT0390061
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 23 - IT0390006
City
Roma
ZIP/Postal Code
00167
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 42 - IT0390005
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 30 - IT0390040
City
Siena
ZIP/Postal Code
53100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 103 - JP0810070
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 99 - JP0810050
City
Kurume
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 104 - JP0810071
City
Maebashi
ZIP/Postal Code
371-8511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 100 - JP0810046
City
Nagakute
ZIP/Postal Code
480-1195
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 101 - JP0810049
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 112 - JP0810045
City
Sapporo
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 105 - JP0810067
City
Sendai
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 98 - JP0810043
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 106 - JP0810068
City
Yokohama
ZIP/Postal Code
236-0004
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 102 - JP0810069
City
Ōsaka-sayama
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 87 - LV3710005
City
Riga
ZIP/Postal Code
1001
Country
Latvia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 82 - LV3710003
City
Riga
ZIP/Postal Code
1003
Country
Latvia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 88 - LV3710004
City
Riga
ZIP/Postal Code
1003
Country
Latvia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 66 - NL0310015
City
Groningen
ZIP/Postal Code
9713
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 79 - PL0480025
City
Rzeszów
ZIP/Postal Code
35055
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 83 - PL0480050
City
Warsaw
ZIP/Postal Code
00-716
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 18 - PL0480048
City
Wrocław
ZIP/Postal Code
50-220
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 19 - PL0480046
City
Wrocław
ZIP/Postal Code
51-685
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 17 - PL0480047
City
Łódź
ZIP/Postal Code
90-647
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 90 - RO0400014
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 89 - RO0400015
City
Iaşi
ZIP/Postal Code
700111
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator 68 - RS381011
City
Belgrade
ZIP/Postal Code
110000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 84 - RS3810010
City
Belgrad
ZIP/Postal Code
11040
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 67 - RS3810012
City
Niš
ZIP/Postal Code
18000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 69 - RS3810009
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 113 - SK4210002
City
Bratislava
ZIP/Postal Code
4210002
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 120 - SK4210004
City
Košice
ZIP/Postal Code
040 11
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 114 - SK4210003
City
Trnava
ZIP/Postal Code
91702
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 32 - ES0340050
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator 24 - ES0340051
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 8 - ES0340053
City
Granada
ZIP/Postal Code
18016
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 12 - ES0340025
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator 20 - ES0340029
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 49 - ES0340058
City
Manises
ZIP/Postal Code
46940
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 48 - ES0340059
City
Mieres
ZIP/Postal Code
33611
Country
Spain
Individual Site Status
Completed
Facility Name
Investigator site 31 - ES0340057
City
Málaga
ZIP/Postal Code
29009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 9 - ES0340052
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 70 - ES0340061
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 33 - UK0440022
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 71 - UK0440036
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 44 - UK0440037
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com

12. IPD Sharing Statement

Learn more about this trial

A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid (BALLAD)

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