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

Bullous Pemphigoid

• Incidence and severity of treatment-emergent AEs, SAEs, and AESIs, • Rate of treatment discontinuation because of safety concerns

Proportions of participants achieving: − CR while off OCS for ≥8 weeks − CR or PR while off OCS for ≥8 weeks − CR while on minimal OCS therapy for ≥8 weeks. (Minimal OCS therapy is defined as ≤0.10 mg/kg/day of prednisone [or an equivalent dose of another OCS]) − CR while off both OCS and efgartigimod PH20 SC for ≥8 weeks − CR or PR while off both OCS and efgartigimod PH20 SC for ≥8 weeks, • Proportions of participants achieving: − CR while off OCS for ≥8 weeks − CR or PR while off OCS for ≥8 weeks − CR while on minimal OCS therapy for ≥8 weeks. (Minimal OCS therapy is defined as ≤0.10 mg/kg/day of prednisone [or an equivalent dose of another OCS]) − CR while off both OCS and efgartigimod PH20 SC for ≥8 weeksb − CR or PR while off both OCS and efgartigimod PH20 SC for ≥8 weeksb, Duration of sustained remission, Proportion of participants who relapse, Time to relapse, Incidence and severity of relapse, BPDAI activity scores, IGA-BP scores, and itch NRS over time, Rate of treatment failure, GTI-related scores, including the GTI-AIS, GTI-CWS, and GTI-SL over time, EQ-5D-5L, DLQI, and ABQoL scores over time, Percent change from baseline over time for anti-BP180 and anti-BP230 antibody levels, Incidence and prevalence of ADA

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