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

Who is this study for? Adults with bullous pemphigoid
What treatments are being studied? Avdoralimab
Status: Completed
Location: See all (4) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female

• ≥ 18 years of age at the time of signing the informed consent document

• Clinical diagnosis of BP confirmed by histology, immunohistochemistry and/or ELISA data

• Patient requiring a treatment by superpotent topical steroids

• Patients hospitalized for the treatment of their BP

• For female, only post-menopaused patients

• For male patients included in the study with partners of child bearing potential should agree to use highly effective contraception for the duration of the study and 6 months after the last dose of avdoralimab

• Signed informed consent document prior to any study related assessments/procedures being conducted

• Patient able to adhere to the study visit schedule and other protocol requirements

• Patient registered to the French Social Security

Locations
Other Locations
France
APHM, Hôpital Nord
Marseille
APHM, Timone
Marseille
CHU Montpellier, Dermatologie
Montpellier
CHU de Nice- Dermatologie
Nice
Time Frame
Start Date: 2020-10-10
Completion Date: 2024-03-31
Participants
Target number of participants: 15
Treatments
Experimental: Drug
Patients in this group will additionally receive 3 s.c. injections of avdoralimab every week during 12 weeks~They 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 lesions
Other: Conventional therapy
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 lesions
Authors
Richard Marie-Aleth
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Nice

This content was sourced from clinicaltrials.gov