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    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7337   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-003078-28
    Sponsor's Protocol Code Number:1368-0016
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-06-17
    Trial results View 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 number2018-003078-28
    A.3Full title of the trial
    Multi-center, double-blind, randomised, placebo-controlled, phase IIb dose-finding study to evaluate efficacy and safety of different subcutaneous doses of BI 655130 in patients with moderate to severe Palmoplantar Pustulosis (PPP)
    Étude de phase IIb multicentrique, en double aveugle, randomisée, contrôlée versus placebo, pour évaluer l'efficacité et la sécurité de différentes doses de BI 655130 en sous-cutané, chez des patients atteints de Psoriasis Palmo-plantaire (PPP) modéré à sévère.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test how effective and safe different doses of BI 655130 are in patients with a moderate to severe form of the skin disease Palmoplantar Pustulosis
    Une étude pour tester l'efficacité et la sécurité de différentes doses de BI 655130 chez les patients atteints d'une forme modérée à sévère de Psoriasis Palmo-plantaire.
    A.4.1Sponsor's protocol code number1368-0016
    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 SponsorBoehringer Ingelheim France
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBoehringer Ingelheim France
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim GmbH & Co KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+18002430127
    B.5.5Fax number+18008217119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.com
    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.3.2Product code BI 655130
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNBI 655130
    D.3.9.2Current sponsor codeBI 655130
    D.3.9.3Other descriptive nameMONOCLONAL ANTIBODY ANTI-IGG1
    D.3.9.4EV Substance CodeSUB31544
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Palmoplantar Pustulosis
    Psoriasis Palmo-Plantaire
    E.1.1.1Medical condition in easily understood language
    Palmoplantar Pustulosis
    Psoriasis Palmo-Plantaire
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10050185
    E.1.2Term Palmoplantar pustulosis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to provide dose-ranging data for 4 dose regimens of BI 655130
    compared to placebo on the primary endpoint of percentage change from baseline in PPP ASI
    at Week 16. The target dose(s) will be estimated from the model by incorporating
    information on the minimum clinically relevant effect and accounting for safety.
    L'objectif principal est de fournir des données sur une gamme de 4 schémas posologiques de BI 655130 par rapport au placebo sur la variation, en pourcentage, par rapport aux valeurs initiales, du score PPPASI à la semaine 16. La ou les doses cibles seront estimées à partir du modèle en intégrant des informations sur les effets minimaux cliniquement pertinents et en tenant compte de la sécurité.
    E.2.2Secondary objectives of the trial
    Supportive dose-ranging assessments will also be done on pre-specified secondary endpoints.
    Des évaluations complémentaires de la gamme posologique seront également effectuées en fonction de critères d'évaluation secondaires préétablis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 18 to 75 years of legal age (according to local legislation) at screening.
    - Diagnosis of Palmoplantar Pustulosis defined as presence of primary, persistent
    (>3 months duration), sterile, macroscopically visible pustules on the palms and/or soles,
    without or with plaque psoriasis elsewhere on the body.
    - Presence of white or yellow pustules on palms and/or soles at screening and baseline.
    - Pustular severity score ≥2 in at least one region and ≥10 well-demarcated pustules (white
    or yellow pustules) across all regions at screening and baseline.
    - PPP PGA of at least moderate severity (≥3) at screening and baseline.
    - A minimum PPP ASI score of 12 at screening and baseline.
    - Male or female patients. Women of childbearing potential (WOCBP) must be ready and
    able to use highly effective methods of birth control per ICH M3 (R2).
    - Signed and dated written informed consent in accordance with ICH-GCP and local
    legislation prior to admission to the trial.
    1. Patients âgés de 18 à 75 ans inclus au moment du screening
    2. Diagnostic de psoriasis plamo-plantaire, défini par la présence de pustules primaires, persistantes (durée >3 mois), stériles, visibles macroscopiquement sur les paumes et/ou la plante des piedsavec ou sans psoriasis en plaques sur le reste du corps.
    3. Présence de pustules blanches ou jaunes sur les paumes et/ou la plante des pieds au screening et à la Baseline.
    4. Un score sur la sévérité des pustules ≥ 2 sur au moins une région et présence d’au moins 10 pustules bien délimitées (blanches ou jaunes) sur toute partie du corps au moment du screening et de la baseline.
    5. Un score PPP PGA avec une sévérité au minimum modérée (≥ 3) au moment du screening et de la baseline
    6. Un score PPP ASI à 12, au minimum, au moment du screening et de la baseline
    7. Patient, homme ou femme. Les femmes en âge de procréer doivent être prêtes à utiliser des méthodes contraceptives hautement efficaces selon l’ICH M3 (R2) qui présentent un taux d’échec faible inférieur à 1% par an lorsqu’elles sont utilisées de façon régulière et correcte. Les méthodes de contraception acceptables pour cette étude sont disponibles dans les renseignements destinés aux patients et à la section 4.2.2.3.
    8. Consentement éclairé daté et signé (en accord avec ICH-GCP et la législation française) avant l’admission dans l’étude
    E.4Principal exclusion criteria
    - Reduction in PPP ASI total score ≥ 5 from screening visit (Visit 1) to baseline
    (randomisation visit, Visit 2).
    - Patients with plaque psoriasis with worsening of plaque psoriasis within the last 3 months
    prior to screening.
    - Skin conditions that affect ability to score area and severity of PPP components (such as
    dyshidrotic eczema, calluses, tinea, xerotic scaling on heels, or maceration of interdigital
    areas).
    - Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
    - Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological,
    endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and
    symptoms thereof.
    - Presence or known history of anti-TNF-induced PPP-like disease.
    - Patient with a transplanted organ (with exception of a corneal transplant >12 weeks prior
    to screening) or who have ever received stem cell therapy (e.g., Prochymal).
    - Known history of lymphoproliferative disease, including lymphoma, or signs and
    symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy
    and/or splenomegaly.

    Further criteria apply.
    1. Reduction du score PPP ASI total ≥ 5 entre le screening (v1) et la baseline (randomisation, v2)
    2. Patients atteints de psoriasis en plaques avec aggravation du psoriasis en plaques au cours des trois derniers mois précédant le screening.
    3. Affections cutanées qui influent sur la capacité à évaluer la surface et la gravité des composantes du PPP (comme l'eczéma dyshidrosique, les callosités, la teigne, la desquamation xérotique des talons, ou la macération des zones interdigitées).
    4. Les femmes enceintes, allaitantes, ou qui prévoient une grossesse pendant l'essai.
    5. Affection grave, évolutive ou non contrôlée telle qu'une maladie rénale, hépatique, hématologique, endocrinienne, pulmonaire, cardiaque, neurologique, cérébrale ou psychiatrique, ou des signes et symptômes de ces affections.
    6. Présence ou antécédents connus d'une maladie de type PPP induite par un anti-TNF.
    7. Patient ayant reçu une greffe d'organe (à l'exception d'une greffe de cornée >12 semaines avant le screening) ou ayant déjà reçu une thérapie par cellules souches (par ex. Prochymal).
    8. Antécédents connus de maladie lymphoproliférative, y compris un lymphome, ou signes et symptômes suggérant une maladie lymphoproliférative, comme une adénopathie et/ou une splénomégalie.

    D'autres critères s'appliquent.
    E.5 End points
    E.5.1Primary end point(s)
    1) Percent change in PPP ASI from baseline
    1) Changement, par rapport à la valeur initiale, du score PPP ASI
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Week 16
    1) 16 semaines
    E.5.2Secondary end point(s)
    1) Change from baseline in PPP Pain Visual Analog Scale (VAS) score
    2) PPP SI change from baseline
    3) PPP ASI50
    4) PPP ASI75
    5) PPP PGA clear/almost clear
    6) PPP PGA pustules clear/almost clear
    7) Percent change in PPP ASI from baseline
    1) Changement par rapport à la valeur intiale de l’échelle visuelle analogique dans le PPP
    2) Changement par rapport à la valeur initiale du score PPP SI
    3) PPP ASI50
    4) PPP ASI75
    5) PPP PGA clair/presque clair
    6) Pustules PPP PGA transparentes/presque transparentes
    7) Changement, en pourcentage, par rapport à la valeur initiale, du score PPP ASI
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Weeks 4 and 16
    2) Week 16
    3) Week 16
    4) Week 16
    5) Week 16
    6) Week 16
    7) Week 52
    1) Semaines 4 et 16
    2) Semaine 16
    3) Semaine 16
    4) Semaine 16
    5) Semaine 16
    6) Semaine 16
    7) Semaine 52
    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 Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Russian Federation
    Switzerland
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days4
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 29
    F.4.2.2In the whole clinical trial 140
    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)
    None
    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 Decision2019-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-07-28
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