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    Summary
    EudraCT Number:2011-000756-42
    Sponsor's Protocol Code Number:MEX0111
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-06-08
    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 ConcernedGermany - BfArM
    A.2EudraCT number2011-000756-42
    A.3Full title of the trial
    A phase 2, multicentre, single arm, pilot study to assess the efficacy and the safety of 150 mg twice a day oral DF2156A in patients with active bullous pemphigoid.
    Pilotstudie der Phase 2, multizentrisch, bei einzelnen Gruppen, zur Beurteilung der Wirksamkeit und der Sicherheit von DF2156A, 150 mg zweimal täglich oral verabreicht, bei Patentien, die an einem bullösen Pemphigoid in der aktiven Phase leiden
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot phase 2 clinical trial performed in some hospitals to evaluate the efficacy and the adverse events in a group of patients with active bullous pemphigoid that will receive DF2156A at the dose of 150 mg, oral route, twice a day.
    A.3.2Name or abbreviated title of the trial where available
    DF2156A in patients with active bullous pemphigoid
    A.4.1Sponsor's protocol code numberMEX0111
    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 SponsorDompé s.p.a.
    B.1.3.4CountryItaly
    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 supportDompé s.p.a.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDompé s.p.a.
    B.5.2Functional name of contact pointDevelopment Project Management
    B.5.3 Address:
    B.5.3.1Street Addressvia San Martino, 12
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20122
    B.5.3.4CountryItaly
    B.5.4Telephone number00390258383500
    B.5.5Fax number00390258383324
    B.5.6E-mailinfo@dompe.it
    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 namenot applicable
    D.3.2Product code DF2156A
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNladarixin
    D.3.9.1CAS number 865625-56-5
    D.3.9.2Current sponsor codeDF2156A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    active bullous pemphigoid
    E.1.1.1Medical condition in easily understood language
    active bullous pemphigoid
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10006567
    E.1.2Term Bullous pemphigoid
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this clinical trial is to evaluate whether DF2156A has a potential in improving the clinical outcome in patients with active blistering BP to warrant its further development. The safety of DF2156A in the specific clinical setting will be also evaluated.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for inclusion into this study, each patient must fulfil the following inclusion criteria.
    - Male and female patients aged >50 years.
    - Patients with newly diagnosed or relapsing bullous pemphigoid based on clinical diagnosis to be confirmed by direct immunofluorescence and indirect immunofluorescence on salt-spit skin (or BP180 and/or BP230 ELISA). Confirmation by laboratory tests will be obtained ideally before or anyway within one week after enrolment.
    For the purpose of this study, clinical relapses are defined as re-appearance of clinical symptoms after the patient had attained remission lasting for more than 3 months without immunosuppressive treatment. In patients with relapsing BP, clinical diagnosis will be confirmed by indirect immunofluorescence or BP180 and/or BP230
    ELISA only.
    - Patients with mild to moderate active blistering disease (total number of blisters between 1 and 30) whether associated or not with urticarial/eczematous lesions.
    - Patients with modified ABSIS score ≤50
    - Patients free from any systemic treatments that may affect the course of the disease with the following off-period prior to enrolment:
    - 3 weeks: steroids, dapsone, tetracyclines, nicotinamide,
    - 3 months: azathioprine, mycofenolate mofetil, cyclophosphamide,
    methotrexate, intravenous immunoglobulins, immunoadsorption, TNF
    antagonists
    - 12 months: rituximab, leflunomide
    - Patients free from any topical treatments other than topical antibiotics and antiseptics in the 4 days prior to enrolment.
    - Patients able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations.
    - Patients able to provide informed consent.
    E.4Principal exclusion criteria
    - Patients with a Karnofsky rating score <40%.
    - Patients with mucosal involvementPatients with moderate to severe renal impairment as per calculated creatinine clearance (CLcr) < 50 mL/min according to the Cockcroft-Gault formula (Cockcroft- Gault, 1976).
    - Patients with hepatic dysfunction defined by increased ALT/AST > 3 x upper limit of normal (ULN) and increased total bilirubin > 3 mg/dL [>51.3 μmol/L].
    - Patients with hypoalbuminemia defined as serum albumin < 3 g/dL.
    - Patients with a baseline (day 0/1, pre-dose) QTcF > 470 msec.
    - Patients who had a myocardial infarction in the 6 months prior to enrolment.
    - Patients on treatment with phenytoin, warfarin, sulphanylurea hypoglycemics (e.g. tolbutamide, glipizide, glibenclamide/glyburide, glimepiride, nateglinide) and high dose of amitriptyline (> 50 mg/day).
    - Patients with known hypersensitivity to non-steroidal antiinflammatory drugs.
    - Patients using any investigational agent within 12 months prior to enrolment.
    - Pregnant or breast feeding women. Unwillingness to use effective contraceptive measures up to 2 months after the end of study drug administration (females and males).
    Patients with hypokalemia defined as serum potassium < 3.5 mmol/L.
    - Patients with clinically relevant bradycardia (heart rate < 50 beats/min)
    - Patients with a complete left bundle branch block.
    - Patients with a history of uncontrolled or labile hypertension
    - Patients with a history of congestive heart failure.
    - Patients with a history of cardiomiopathy.
    - Patients with unstable angina pectoris
    - Patients with a personal or family history of congenital or documented acquired QT interval prolongation
    - Patients with a significant atrial or ventricular arrhythmia or symptomatic arrhythmia in the past.
    E.5 End points
    E.5.1Primary end point(s)
    Total number of blisters and percent change from baseline; Modified ABSIS score and percent change from baseline; Physician Global Assessment (PGA) score measured on a 0-10 scale; Absolute value and % change from baseline; Pruritus measured on a 10 cm visual analogue scale. Absolute value and percent change from baseline; Eosinophil blood count. Absolute number and percent change from baseline; Number and percentage of patients with treatment failure (drug discontinuation due to disease worsening); Number and percentage of patients completely free from blisters; Number of patients who are still free from blisters without requiring any systemic or topical rescue treatment - Optional
    E.5.1.1Timepoint(s) of evaluation of this end point
    time frame: day 0/1 (predose), 8 and 15; time frame: day 0/1 (predose), 8 and 15; time frame: day 0/1 (predose), 8 and 15; time frame: screenitime frame: day 8ng and day 15; time frame: day 8; time frame: day 30
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 4
    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 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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 12
    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)
    Not applicable
    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 Decision2011-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-07-11
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