NCT04563923

Treatment of Bullous Pemphigoid With Avdoralimab (IPH5401), an Anti-C5aR1 Monoclonal Antibody

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Bullous Pemphigoid

Interventions

Type	Name	Description
DRUG	Avdoralimab (IPH5401)	Preparation of avdoralimab and preparation of the syringes are to be performed aseptically by site pharmacy qualified personnel.
OTHER	Control	Superpotent topical steroids are the gold standard treatment for BP. All patients will receive 0.05% Clobetasol propionate cream as follows: * Patients of less than 45kg of body weight: 2 tubes of 10g/d * Patients of 45kg and above of body weight: 3 tubes of 10g/d Topical steroids will be applied every day until 15 days after the healing of the last bullous lesion

Timeline

• Start date: 2020-10-10
• Primary completion: 2023-04-30
• Completion: 2024-03-31
• First posted: 2020-09-25
• Last updated: 2026-03-24

Locations

4 sites across 1 country: France