An Open-label Extension Study of ARGX-113-2009 to Evaluate the Long term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
- Conditions
- Bullous Pemphigoid1000381610040790
- Registration Number
- NL-OMON56108
- Lead Sponsor
- argenx BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 2
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. Women must use one of the contraception methods
described in the protocol from signing the ICF until the last dose of IMP
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Incidence and severity of treatment-emergent adverse events (TEAEs), serious<br /><br>AEs (SAEs), and AEs of special interest (AESIs)<br /><br>• Rate of treatment discontinuation because of safety concerns</p><br>
- Secondary Outcome Measures
Name Time Method