A follow up study of ARGX-113-1904 to give the option to prolong the treatment with efgartigimod PH20 SC, in patients who suffer from a skin blistering disease called pemphigus (Vulgaris or Foliaceus)
- Conditions
- Health Condition 1: L102- Pemphigus foliaceousHealth Condition 2: L100- Pemphigus vulgaris
- Registration Number
- CTRI/2021/02/031558
- Lead Sponsor
- argenx BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safety of extended treatment and <br/ ><br>retreatment with efgartigimod PH20 SC in patients with PV or PFTimepoint: a. 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)- Upto 60 weeks. <br/ ><br>b. Vital sign measurements, physical examinations, electrocardiograms (ECGs), <br/ ><br>and clinical laboratory safety evaluations- Upto 60 weeks
- Secondary Outcome Measures
Name Time Method