Treatment of bullous pemphigoid with avdoralimab (IPH5401), an anti-C5aR1 monoclonal antibody

Phase 1

• Conditions: Auto Immune bullous Diseases; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2020-002912-34-FR
• Lead Sponsor: CHU NICE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-22
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 deprived of freedom

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified