A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod PH20 SC in adults with Pemphigus (Vulgaris or Foliaceus)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

Participants must meet all of the following 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 patient participated in trial ARGX-113-1904 and completed the study or has the defined criteria for rollover.
3. Women of childbearing potential:
a. Must have a negative urine pregnancy test at baseline before trial medication can be administered.
b. Must be on a stable regimen for at least 1 month of at least 1 highly effective method of contraception (ie, failure rate of less than 1% per year) during the trial and for 90 days after the last administration of IMP.
4. Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use effective contraception from first administration of IMP through 90 days after the last administration of the IMP. Male patients practicing true sexual abstinence (as consistent with preferred and usual life style) can be included. Sterilized male patients who have had a vasectomy and with documented absence of sperm post-procedure can be included. Male patients are not allowed to donate sperm from first administration of IMP through 90 days after 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 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

Participants are excluded from the trial if any of the following criteria apply:
1. Pregnant and lactating women and those intending to become pregnant during the trial or within 90 days after the last administration of IMP.
2. Patients with clinical evidence of other significant serious disease or patients 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 patient at undue risk.
3. Known hypersensitivity to any of the components of the administered treatments.

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 safety of extended treatment and re-treatment with efgartigimod PH20 SC in patients with PV or PF;Secondary Objective: To evaluate the efficacy of efgartigimod PH20 SC treatment in PV and PF<br>To evaluate the effects of efgartigimod PH20 SC on quality of life (QoL) in patients with PV or PF<br>To evaluate the pharmacokinetics (PK) of efgartigimod PH20 SC in patients with PV or PF<br>To evaluate the PD of efgartigimod PH20 SC in patients with PV or PF<br>To evaluate the immunogenicity of efgartigimod PH20 SC in patients with PV or PF<br>;Primary end point(s): 1. Incidence and severity of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) by System Organ Class (SOC) and Preferred Term (PT)<br>2. Vital signs, physical examination, electrocardiogram (ECG), and clinical laboratory safety evaluations;Timepoint(s) of evaluation of this end point: Up to 60 weeks

Secondary Outcome Measures

Name	Time	Method

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