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    Summary
    EudraCT Number:2013-001885-41
    Sponsor's Protocol Code Number:DLX105-003-002-001
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-14
    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 ConcernedAustria - BASG
    A.2EudraCT number2013-001885-41
    A.3Full title of the trial
    A multi-center, double-blinded, randomized, placebo-controlled, phase II study to evaluate the safety, tolerability and efficacy of a topical application of DLX105 onto lesional skin in patients with mild-to-moderate psoriasis vulgaris
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multi-center, blinded, randomized study to assess the safety, tolerability and efficacy of an application of DLX105 onto affected skin in comparison to placebo in patients with mild-to-moderate psoriasis vulgaris
    A.4.1Sponsor's protocol code numberDLX105-003-002-001
    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 SponsorDelenex Therapeutics AG
    B.1.3.4CountrySwitzerland
    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 supportDelenex Therapeutics AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDelenex Therapeutics AG
    B.5.2Functional name of contact pointClinical Trial Operations
    B.5.3 Address:
    B.5.3.1Street AddressWagistr. 27
    B.5.3.2Town/ citySchlieren/Zürich
    B.5.3.3Post code8952
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41447309165
    B.5.5Fax number+41447305181
    B.5.6E-mailclaudia.berger@delenex.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.3.1Product nameDLX105
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNhumanized single-chain antibody fragment for TNF-alpha inhibition
    D.3.9.2Current sponsor codeDLX105
    D.3.9.3Other descriptive nameDLX105
    D.3.9.4EV Substance CodeSUB33550
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,5
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 placeboGel
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    mild-to-moderate plaque-type psoriasis vulgaris 6 (PASI ≤15)
    E.1.1.1Medical condition in easily understood language
    mild-to-moderate psoriasis expressed by lesional skin
    E.1.1.2Therapeutic area Body processes [G] - Cell Physiological Phenomena [G04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10050576
    E.1.2Term Psoriasis vulgaris
    E.1.2System Organ Class 100000004858
    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 safety and tolerability of DLX105 administered topically onto the psoriatic lesion of mild-to-moderate psoriatic patients

    • To determine the efficacy of a formulation of DLX105 administered topically, measured by local PASI scores at two different plaques at wk4 compared to baseline
    E.2.2Secondary objectives of the trial
    • To determine the pharmacokinetics (PK) and Immunogenicity of DLX105 upon topical application onto the psoriatic lesion of mild-to-moderate psoriatic patients

    • To evaluate the impact of weekly pre-treating psoriatic skin by tape-stripping on the clinical response

    exploratory:
    • To evaluate biomarkers (such as TNF-alpha, IL-17, IL-23, epidermal thickness, Ki67 expression) in skin biopsies.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients eligible for inclusion in this trial have to fulfil all of the following criteria:
    1. Signed and dated informed consent prior to initiation of any study procedures.
    2. Male or female Caucasian aged 18-75 years.
    3. Male or female patients with stable chronic mild-to-moderate plaque-type psoriasis (PASI ≤15).
    4. Male or female Caucasian patients with stable chronic mild-to-moderate plaque-type psoriasis (PASI ≤15) aged 18-75 years who must have at least two psoriasis lesions of >9 cm2 (located at arms and/or trunk, excluding elbows and legs), stable for at least 3 months, local PASI score ≥8.
    5. Affected body surface area (BSA) ≤10%.
    6. Negative pregnancy test for females of child-bearing potential (pre-menopausal,
    <2 years post-menopausal, not surgically sterile).
    7. Willing and able to participate in the trial as an outpatient and comply with all trial requirements.
    E.4Principal exclusion criteria
    Patients who fulfil one or more of the following criteria will not be eligible for inclusion in this trial:
    1. Forms of psoriasis other than chronic plaque-type only (e.g., pustular, erythrodermic and guttate psoriasis, palmar, plantar or nail disease) at screening.
    2. Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) prior to randomization
    3. Ongoing use of prohibited psoriasis treatments (duration of washout, i.e. discontinuation prior to randomization):
    a. Biological agents, e.g. adalimumab, etanercept, infliximab, ustekinumab, alefacept (12 weeks)
    b. Systemic therapy for psoriasis and psoriatic arthritis (other than above) e.g. methotrexate, cyclosporin, fumaric acid (derivatives), systemic steroids (4 weeks)
    c. Photochemotherapy e.g., ultraviolet A with psoralen (PUVA) (4 weeks)
    d. Phototherapy e.g., ultraviolet A (UVA) or ultraviolet B (UVB) (2 weeks)
    e. Topical therapies for the treatment of Ps such as corticosteroids, vitamin D analogues or retinoids within 14 days prior to baseline
    f. Other investigational psoriasis drugs (4 weeks or 5 half-lives, whichever is longer)
    4. Intake of any investigational drug or participation in a Clinical Trial within 4 weeks or 5 half-lives, (whichever is longer) prior to baseline.
    5. History or evidence of active tuberculosis. All patients will be tested for tuberculosis status using a blood test (QuantiFERON TB-Gold) unless this test has been performed within 4 months prior to randomization and was negative. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment has been initiated according to local regulations.
    6. Active systemic infections (other than common cold) during the two weeks before randomization
    7. Positive test for hepatitis B or C at screening
    8. Positive test for HIV at screening
    9. History or symptoms of malignancy of any organ system (other than history of basal cell carcinoma and / or up to three squamous cell carcinomas of the skin, if successful treatment has been performed, with no signs of recurrence; actinic keratosis, if present at screening, should be treated according to standard therapy before randomization), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
    10. History of severe hypersensitivity to any human or humanized biological agents
    11. Any severe, progressive or uncontrolled medical condition at baseline that in the judgment of the investigator prevents the patient from participating in the study.
    12. Any clinically significant abnormal laboratory tests at screening
    13. Active liver disease with alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) > 3 x upper limit of normal at screening
    14. History of moderate or severe congestive heart failure (New York Heart Association [NYHA] class III or IV)
    15. Inability or unwillingness to undergo repeated venipunctures (e.g., due to poor tolerability or lack of access to veins)
    16. History or evidence of drug or alcohol abuse within the 6 months prior first study drug administration
    17. Patients who had live vaccination within 6 weeks prior first study drug administration, or will require live vaccination during the course of the trial
    18. History of hypersensitivity to any of the excipients of the study drugs or to excipients of similar chemical classes
    19. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (HCG) laboratory test (> 5 mIU/mL)
    20. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. UNLESS they are women whose partners have been sterilized by vasectomy
    a. Using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, condoms (by the partner), and intrauterine devices (IUDs)). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not considered acceptable forms of birth control within this study
    b. Reliable contraception should be maintained throughout the study and for 2 weeks after the last study drug administration
    No additional exclusion criteria may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    • Evaluation of local tolerability of topical administration of DLX105 in mild-to moderate psoriatic patients, measured by patients (VAS) and investigators (validated score) for each treatment area.
    • Evaluation of treatment-related adverse events (AEs)
    • Detection of anti-drug antibodies (ADAs). Assessment of immunogenic potential of topically administered DLX105 by ELISA with coated DLX105 to capture anti-DLX105 antibodies

    Efficacy:
    • Evaluation of clinical signs of activity to local administration of DLX105 measured by local PASI score per treatment area at week 4 compared to baseline, in mild-to-moderate psoriatic patients.
    • Assessment of the difference of clinical signs of activity to local administration of DLX105 compared to placebo, measured by local PASI score per treatment area at week 4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety:
    investigator's assessment of tolerability: Visit 2 (baseline) to visit 8 (week 6, follow-up, end of study), weekly visits except visit 8 (2 weeks after visit 7 (last treatment))

    patient's assessment of tolerability: visit 2 to visit 7

    Efficacy:
    local PASI (SOS): visit 2, visit 4 to visit 8
    photo documentation: visit 2, visit 7
    E.5.2Secondary end point(s)
    Efficacy
    • Evaluation of clinical signs of activity to local administration of DLX105 measured by local PASI score per treatment area at week 6 compared to baseline, in mild-to-moderate psoriatic patients.
    • Assessment of the difference of clinical signs of activity to local administration of DLX105 compared to placebo, measured by local PASI score per treatment area at week 6.
    • Evaluation of impact of weekly pre-treating psoriatic skin by tape-stripping on the clinical response, measured by difference of local PASI score between pre-treated and non-pre-treated areas at week 4 in mild-to-moderate psoriatic patients.
    E.5.2.1Timepoint(s) of evaluation of this end point
    visit 2 (baseline), visit 7 (last treatment), visit 8 (week 6, follow-up, end of study)
    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 Yes
    E.6.13.1Other scope of the trial description
    immunogenicity
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 years0
    E.8.9.1In the Member State concerned months8
    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 months8
    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: 44
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 54
    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)
    expected normal treatment of that condition
    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 Decision2013-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-04-22
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