Treatment of Bullous Pemphigoid With Avdoralimab (IPH5401), an Anti-C5aR1 Monoclonal Antibody
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
The development of Auto Immune bullous Diseases (AIBD) results from a complex interaction
between innate and adaptive immune systems. Bullous pemphigoid (BP), the most frequently
encountered AIBD, predominantly affects elderly patients above 70 with an estimated incidence
of 21.7 new cases/million/year in France.Interestingly, coversin, an anti-C5a and
-leukotriene B4 small molecule, is currently used in a phase IIA clinical trial in BP
patients (NCT04035733). However, although overall C5-blocking drugs are potentially
interesting, they are likely to interfere with C5a-C5aR2-axis activation as well, a pathway
that has recently proved protective in BP 12. The main objective is to investigate the
clinical efficacy of an anti-C5aR1 antibody in addition to superpotent topical steroids
compared to superpotent topical steroids alone in BP patients at 3 months.It is a
case-controlled, randomized, open-labelled, and multicenter phase II clinical trial. Four
Dermatologic French centers (Nice, Marseille Nord, Marseille Timone and Montpellier
university hospitals) specialized in the in the care of BP patients will be participating in
the study. It is expected that forty subjects will be included in this trial.
Conversely, a more targeted inhibition of C5a-C5aR1 axis might be more effective in BP,
sparing the potentially protective effect of C5a-C5aR2 interaction.
Avdoralimab (IPH5401), a specific anti-C5aR1 monoclonal antibody, has already been credited
of a good safety profile in the treatment of solid tumors and rheumatoid arthritis. The
investigators hypothesize that avdoralimab might be a safe and effective treatment in BP
patients