Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-003785-13
    Sponsor's Protocol Code Number:KTDIIS02
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-27
    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 ConcernedSweden - MPA
    A.2EudraCT number2021-003785-13
    A.3Full title of the trial
    An investigator-initiated, open label trial to investigate efficacy of brodalumab in eczematized psoriasis
    (BRodalumab in Eczematized PSOriasis)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to investigate efficacy of brodalumab in eczematized psoriasis
    A.3.2Name or abbreviated title of the trial where available
    BREPSO
    A.4.1Sponsor's protocol code numberKTDIIS02
    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 SponsorKarolinska Universitetssjukhuset
    B.1.3.4CountrySweden
    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 supportLeo Pharma
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska Universitetssjukhuset
    B.5.2Functional name of contact pointVictor Bloniecki Kallio
    B.5.3 Address:
    B.5.3.1Street AddressEugeniavägen 3
    B.5.3.2Town/ citySolna
    B.5.3.3Post code17164
    B.5.3.4CountrySweden
    B.5.6E-mailvictor.bloniecki.kallio@ki.se
    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 Yes
    D.2.1.1.1Trade name Brodalumab
    D.2.1.1.2Name of the Marketing Authorisation holderLäkemedelsverket
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameBrodalumab
    D.3.4Pharmaceutical form Injection
    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 INNBrodalumab
    D.3.9.3Other descriptive nameKyntheum
    D.3.9.4EV Substance CodeSUB180076
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    eczematized psoriasis
    E.1.1.1Medical condition in easily understood language
    Psoriasis with eczema like features
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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
    The objective of the trial is to characterize eczematized psoriasis from a molecular and immunological perspective
    The primary endpoint is the identification of differentially expressed genes in lesional epidermis at baseline and week 12.
    E.2.2Secondary objectives of the trial
    This trial will also investigate the efficacy of Brodalumab for the treatment of eczematized psoriasis patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Suspected diagnosis of eczematized psoriasis with a PASI score ≥ 10 as defined below, age 18-80 years, body weight ≥ 40 kg and ≤ 160 kg, signed informed consent from patient.
    Definition of suspected diagnosis of eczematized psoriasis: at least two criteria fulfilled in both columns
    Psoriasis-related criteria Eczema-related criteria
    Extensor distribution Flexural distribution
    Inverse distribution Lichenification
    Nail phenomena of psoriasis Vesicles
    Psoriatic arthritis Serum crusts
    Negative smear test for S. aureus S.aureus detection
    Positive family history of psoriasis Positive family history of eczema
    Histology: elongated capillary loops in the papillary dermus Positive specific IgE to common aeroallergens
    Histology: Munro’s micro-abscesses Histology: spongiosis
    Histology: hyper-parakeratosis Histology: eosinophils
    E.4Principal exclusion criteria
    Pregnancy or breast feeding, women of child-bearing potential unless they use highly effective contraception during the study and for 4 weeks after study completion or discontinuation, history or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia, myocardial infarction or cardiac arrhythmia which requires drug therapy, evidence of severe renal dysfunction or significant hepatic disease, history of lymphoproliferative disorders, patients who are considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits, inability or unwillingness to undergo repeated venipuncture or skin punch biopsies, any systemic immune-activetreatment within 4 weeks or 5 biologic half-lifes (whichever is longer) or immune-active topical treatment within one week before inclusion, history of failed treatment with an IL-17 inhibitor, history of clinical significant medical condition or any other reason, which the investigator determines would interfere with the subject´s participation in this study or would make the subject unsuitable candidate to receive study drug or would put the subject at risk by participating in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Differentially expressed genes in lesional epidermis at baseline and week 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    Proportion of patients reaching at least 90% relative improvement from baseline in the Psoriasis Area and Severity Index (PASI) at 12 weeks of Brodalumab treatment.
    PASI 75 score at weeks 4 and 12
    The proportion of subjects who achieve at least a 75% reduction in the EASI score at weeks 4 and 12 compared to week 0 (Baseline). PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration, and desquamation are scored on a scale of 0 (none) to 4 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 to 6. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the PASI score.

    PASI 50 score at weeks 2, 4 and 12
    The proportion of subjects who achieve at least a 50% reduction in the PASI score at weeks 2, 4, and 12 compared to week 0 (Baseline).

    PASI 100 score at week 12
    The proportion of subjects who achieve a 100% reduction in the PASI score at week 12 compared to week 0 (Baseline).

    Absolute Change from baseline in PASI score at weeks 2, 4, and 12

    Change from baseline in Investigator Global Assessment (IGA) at weeks 4 and 12
    Definition of the IGA 5 point scale 24:
    0 Cleared: No plaque elevation, erythema or scaling; hyperpigmentation may be present
    1 Minimal: Minimal plaque elevation (=0,25 mm); faint erythema; minimal scaling, with occasional fine scale over 55% of lesion
    2 Mild: Mild plaque elevation (=0,5 mm); light red coloration; fine scale predominates
    3 Moderate: Moderate plaque elevation (=0,75 mm); moderate red coloration; coarse scale predominates
    4 Marked: Moderate plaque elevation (=1 mm); bright red coloration; thick, nontenacious scale predominates
    5 Severe: Severe plaque elevation (>1,25 mm); dusky to deep red coloration; very thick, tenacious scale predominates

    Change from baseline in the Dermatology Life Quality Index (DLQI) Total Score at weeks 4 and 12
    DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much the skin has been a problem at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.

    Change from baseline in Peak Pruritus Numerical Rating Scale (NRS) Score at weeks 4 and 12
    NRS are used to measure the amount of itching and discomfort a participant experiences. All NRS values range from 0 to 10 (0 = no pruritus, 10 = worst pruritus imaginable) and are reported on each visit. Maximum itch intensity in the last 24 hours before the visit is asked for. Change from baseline is calculated for the NRS scale, where change = visit value − baseline value.

    Change from baseline in the Montgomery – Åsberg depression rating scale (MADRS) at weeks 4 and 12
    The MADRS was developed and validated to measure the severity of depressive episodes. It contains 10 items that each yield from 0-6, thus 60 is the highest possible score. 7-19 points argue for mild depression, 20-34 for moderate, and >34 for severe depression.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2, 4 and 12 weeks
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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
    Characterization of change in gene expression in lesional skin following drug treatment.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 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
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state15
    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)
    Standard care
    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 Decision2021-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-26
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 02 11:42:46 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA