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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 April 2024 |
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Main ID: |
NCT04563923 |
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Date of registration:
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17/09/2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Treatment of Bullous Pemphigoid With Avdoralimab (IPH5401), an Anti-C5aR1 Monoclonal Antibody
IPH |
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Scientific title:
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Treatment of Bullous Pemphigoid With Avdoralimab (IPH5401), an Anti-C5aR1 Monoclonal Antibody |
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Date of first enrolment:
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October 10, 2020 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04563923 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Passeron Thierry, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU de Nice, Dermatologie |
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Key inclusion & exclusion criteria
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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 deprived of freedom
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Bullous Pemphigoid
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Intervention(s)
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Other: Control
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Drug: Avdoralimab (IPH5401)
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Primary Outcome(s)
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Complete Clinical Remission
[Time Frame: At 3 Months]
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Secondary Outcome(s)
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The delay
[Time Frame: At 3 months]
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Initial Clinical Remission
[Time Frame: At 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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