Auto Immune bullous Diseases
Conditions
Interventions
Product Name: avdoralimab
Product Code: IPH5401
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion
INN or Proposed INN: avdoralimab
CAS Number: 2226393-85-5
Current Sponso
Sponsors
CHU NICE
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 1.To compare between the treatment groups the delay to complete clinical remission (CCR) 2.To compare between the treatment groups the delay to initial clinical remission (ICR) 3.To compare between the treatment groups the impact on the relapses 4.To compare between the two treatment groups the delay to the relapse 5.To compare the quality of life (QoL) between the treatment groups at W4, W8 and W12 6.To compare the efficacy of the treatments on the pruritus at W4, W8 and W12 7.To compare between the two treatment groups the consumption of topical steroids over the study period 8.To assess the tolerance of avdoralimab ;Primary end point(s): The efficacy will be evaluated through the proportion of patients in complete clinical remission (CCR) at 3 months without any relapse during the study period. The CCR will be defined as the absence of new bullous and skin inflammatory lesions and absence of pruritus (VAS for pruritus <3) for at least 2 weeks. The patient will report daily on his leaflet the presence of lesions so that, at the next study visit, the investigator will determine precisely the date of CCR. ;Timepoint(s) of evaluation of this end point: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The delay to achieve CCR (first CCR occurrence during study period) will be defined as the time, in days, between the date of the baseline visit and the date of CCR.as it is defined above. Follow-up will be censored at 3 months for patients not achieving CCR or at the date of last visit completed for the lost to follow-up. 2. ICR is defined as the absence of new bullous and skin inflammatory lesions and absence of pruritus (VAS for pruritus 2/10 on the VAS and at least 3 bullous or inflammatory lesions/d for at least 3 consecutive days). 5. The delay to the relapse will be defined, in people previously achieving CCR, as the time, in days, between the date of the CCR and the date of the relapse as reported by the patient. Follow-up will be censored at 3 months for patients not having a relapse or at the date of last visit completed for the lost to follow-up. 6. The QoL will be evaluated using the DLQI score. The Dermatology life Quality Index (DLQI) is a simple ten-question auto questionnaire used to measure the impact of skin disease on the quality of life of an affected person. It is designed for people aged 16 years and above. DLQI score 13 (Annex 1) is validated in the frame of dermatological clinical research. A French version is validated14. The QoL evolution will be assessed successively between baseline and (W4, W8 and W12). 7. A visual analogical scale (VAS) will be used for pruritus self-assessment. The patient will use a VAS calibrated from 0 to 100 mm, not hatched, marked at each end, on one side "no pruritus at all" and on the other side "most intense pruritus" and he will be asked to grade his level of pruritus during the past 7 days. The pruritus evolution will be assessed successively between baseline and (W4, W8 and W12). 8. The consumption of topical steroids will be evaluated by the quantity, in grams, of drugs used over the study period. At W4, W8 and W12 the patients will bring back all their tubes which will be w | — |
Countries
France
Contacts
Public ContactCaillon
CHU Nice
Outcome results
None listed