A phase 3 study to evaluate the long-term safety, tolerability and efficacy of efgartigimod PH20 SC in adult participants with bullous pemphigoid

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 160

Inclusion Criteria

1. Has completed the week 36 visit of ARGX-113-2009
2. Is capable of providing signed informed consent and complying with protocol requirements
3. Agrees to use contraceptive measures consistent with local regulations and the following:
a. Male participants: An acceptable method of contraception is a condom. All nonsterilized male participants must use this method from signing of the ICF until the date of the last dose of IMP.
b. Women of childbearing potential must have a negative urine pregnancy test at baseline before receiving IMP. WOCBP must use one of the contraception methods described in the protocol from signing the ICF until the last dose of IMP
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

1. Clinically significant disease, recent major surgery (within 3 months of baseline), or intention to have surgery during the study; or any other medical condition that, in the investigator’s opinion would confound the results of the study or put the participant at undue risk
2. Known hypersensitivity to IMP or 1 of its excipients
3. Permanently discontinued IMP in ARGX-113-2009 due to an AE considered related to IMP and for whom the benefit/risk balance is not considered positive

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the long-term safety and tolerability of treatment with efgartigimod PH20 SC in participants with BP;Secondary Objective: To assess the long-term efficacy and durability of response with efgartigimod PH20 SC treatment in participants with BP<br>To evaluate the impact of efgartigimod PH20 SC treatment in reducing long-term glucocorticoid-associated toxicity in participants with BP<br>To evaluate the impact of efgartigimod PH20 SC treatment on QoL in participants with BP<br>To evaluate the PD and immunogenicity of efgartigimod PH20 SC in participants with BP;Primary end point(s): Incidence and severity of treatment-emergent adverse events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs) <br>Rate of treatment discontinuation because of safety concerns<br>;Timepoint(s) of evaluation of this end point: Up to wk 56

Secondary Outcome Measures

Name	Time	Method

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