CompletedPhase 2

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

France15 participantsStarted 2020-10-10

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Patients requiring systemic steroids according to the physician in charge * Contra indication to topical steroid * Use of systemic steroids or any immunosuppressive drugs in the past 4 weeks * Use of doxycycline or minocycline in the past 4 weeks * Use of systemic rituximab or omalizumab or dupilimumab in the past 12 weeks * Use of intravenous immunoglobulmins (IVIG) in the past 4 weeks * Impossibility to come every week to receive the injection * Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation * Vulnerable people: pregnant or breast-feeding women, minors, adult under guardianship or depr…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Complete Clinical Remission

Timeframe: At 3 Months

Trial details

NCT IDNCT04563923

SponsorCentre Hospitalier Universitaire de Nice

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-30

View on ClinicalTrials.gov More Bullous Pemphigoid trials