Bullous Pemphigoid
Conditions
Interventions
At rollover, participants will be treated with efgartigimod PH20 SC according
to their clinical status at the EoTP visit of ARGX-113-2009. A summary of the
treatment interventions is provided in Tab
Sponsors
argenx BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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. Women must use one of the contraception methods described in the protocol from signing the ICF until the last dose of IMP
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Incidence and severity of treatment-emergent adverse events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs) • Rate of treatment discontinuation because of safety concerns | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the long-term efficacy and durability of response with efgartigimod PH20 SC treatment in participants with BP : • Proportions of participants who: * Achieve complete remission (CR) and have been off oral corticosteroids (OCS) for >=8 weeks * Achieve CR or partial remission (PR) and have been off OCS therapy for >=8 weeks * Achieve CR and have been on minimal OCS therapy for >=8 weeks. (Minimal OCS therapy is defined as =8 weeks * Are in CR or PR and have been off both OCS and efgartigimod PH20 SC for >=8 weeks • Duration of sustained remission • Proportion of participants who relapse • Time to relapse • Incidence and severity of relapse • Bullous Pemphigoid Disease Area Index (BPDAI) activity scores, Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) scores, and itch numerical rating scale (NRS) over time • Rate of treatment discontinuation due to efficacy concerns | — |
Countries
Netherlands
Outcome results
None listed