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    Summary
    EudraCT Number:2020-002912-34
    Sponsor's Protocol Code Number:20-PP-13
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-22
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2020-002912-34
    A.3Full title of the trial
    Treatment of bullous pemphigoid with avdoralimab (IPH5401), an anti-C5aR1 monoclonal antibody
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of bullous pemphigoid with avdoralimab (IPH5401), an anti-C5aR1 monoclonal antibody
    A.3.2Name or abbreviated title of the trial where available
    PB
    A.4.1Sponsor's protocol code number20-PP-13
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU NICE
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCHU de Nice
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Nice
    B.5.2Functional name of contact pointCaillon
    B.5.3 Address:
    B.5.3.1Street AddressRCI-Hôpital Cimiez - 4 avenue Reine Victoria
    B.5.3.2Town/ cityNice
    B.5.3.3Post code06001
    B.5.3.4CountryFrance
    B.5.4Telephone number0033492034589
    B.5.5Fax number0033492034075
    B.5.6E-mailcaillon.c@chu-nice.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameavdoralimab
    D.3.2Product code IPH5401
    D.3.4Pharmaceutical form Powder for concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNavdoralimab
    D.3.9.1CAS number 2226393-85-5
    D.3.9.2Current sponsor codeIPH5401
    D.3.9.3Other descriptive nameNNC0215-0384
    D.3.9.4EV Substance CodeSUB33404
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Auto Immune bullous Diseases
    E.1.1.1Medical condition in easily understood language
    Auto Immune bullous Diseases
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    E.4Principal 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
    E.5 End points
    E.5.1Primary 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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    E.5.2Secondary 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 <3) for at least 4 consecutive days. This delay will be defined as the time, in days, between the date of the baseline visit and the date of ICR. Follow-up will be censored at W3 for patients not achieving ICR or at the date of last visit completed for the lost to follow-up.
    3. The initial failure of treatment will be defined as the absence of ICR (see endpoint 2) at W3.
    4. The impact of treatment on relapses will be studied using the incidence rate of the relapses and the rate of patients presenting with at least one relapse over the study period. Relapse will be defined as the reappearance, in a patient who previously achieved CCR, of skin inflammatory and/or bullous lesions and/or pruritus (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 weighted, and the quantity used reported.
    9. All the adverse events (clinical and biological) occurring over the study period will be collected with their type, grade and severity. At each visit the investigator will record all the events since the last visit and check for any biological trouble on the systematic blood analyses
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    6 months
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months13
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months13
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The participation of the patients in the study ends after this visit, and their follow-up is resumed based on the guidelines for their condition. If the patient is still in remission at the end of the study, disease status will be collected regularly until relapse.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-04
    P. End of Trial
    P.End of Trial StatusOngoing
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