Treatment of Bullous Pemphigoid with Avdoralimab: Multicenter, Randomized, Open-Labeled Phase 2 Study

Abstract

RationaleExperimental data support the role for C5a-C5aR1-axis activation in bullous pemphigoid (BP). We assessed the efficacy and safety of avdoralimab, a specific anti-C5aR1 monoclonal antibody, for treating BP. MethodsWe conducted a Phase 2 open-labelled randomized multicenter study. Patients with proven BP were randomized (1:1) to receive superpotent topical steroids (STS) alone (group A) or with avdoralimab (group B). All patients received 0.05% clobetasol propionate cream until 15 days after the healing of lesions. Patients in group B additionally received 3 injections of avdoralimab every week during 12 weeks. The main criterion of evaluation was the proportion of patients with initial control of disease activity (CDA) still in complete clinical remission (CCR) at 3 months with no relapse during the study period. ResultsFifteen patients were randomized, 7 to group A and 8 to group B. Two patients in group A and in group B achieved CDA at week 4. Only one patient was still in CCR at week 12 in group B and none in group A.. No adverse event related to the treatment was reported. ConclusionsThis proof of concept pilot study did not show preliminary signal of additional avdoralimab efficiency compared to STS alone.