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    Summary
    EudraCT Number:2019-002383-27
    Sponsor's Protocol Code Number:CHDR1806
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-06-13
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-002383-27
    A.3Full title of the trial
    An exploratory, single-center, double-blinded, healthy volunteer controlled study to characterize psoriasis patients and explore novel biomarkers for the treatment response of psoriasis with a multi-modal patient profiling approach
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An explorative psoriasis biomarker study
    A.4.1Sponsor's protocol code numberCHDR1806
    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 SponsorCentre for Human Drug Research
    B.1.3.4CountryNetherlands
    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 supportJanssen-Cilag B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre for Human Drug Research
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressZernikedreef 8
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CL
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715246400
    B.5.5Fax number+31715246499
    B.5.6E-mailclintrials@chdr.nl
    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 Tremfya 100 mg solution for injection in pre-filled pen
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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 INNGUSELKUMAB
    D.3.9.3Other descriptive nameGUSELKUMAB
    D.3.9.4EV Substance CodeSUB179789
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    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
    Psoriasis
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study is divided into two sections:
    Part A is a healthy volunteer controlled observational study to determine the course of the disease over time to:
    - Evaluate disease-related biomarkers in psoriasis when compared with healthy volunteers;
    - Evaluate the variability of the selected biomarkers between subjects, and within subjects over time.
    Part B is an interventional and placebo controlled study in psoriasis patients to:
    - Evaluate the biomarker for use in disease-monitoring after pharmacological intervention
    E.2.2Secondary objectives of the trial
    N.A.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy volunteers
    Eligible healthy volunteers must meet all of the following inclusion criteria at screening:
    1. Male or non-pregnant female subjects, 18 to 75 years of age (inclusive); during COVID-19 pandemic this is set to 18 to 69 year of age (inclusive)
    2. Healthy as defined by the absence of any uncontrolled active or uncontrolled chronic disease following a medical and surgical history, documentation of general symptoms, and a symptom-directed physical examination including vital signs;
    3. Willing to give written informed consent and willing and able to comply with the study protocol;

    Psoriasis patients
    Eligible psoriasis patients must meet all of the following inclusion criteria at screening:
    1. Male or non-pregnant female subjects, 18 to 75 years of age (inclusive); during COVID-19 pandemic this is set to 18 to 69 year of age (inclusive)
    2. Diagnosed with plaque psoriasis at least 6 months prior to study participation
    3. Willing to discontinue any psoriasis therapy other than emollients.
    4. Having mild ((BSA PASI ≥1 and ≤ 5) (BSA ≥1% andPASI ≤ 5%) or moderate-to-severe (PASI ≥ 10) plaque psoriasis
    5. Currently not using psoriasis medication and ≥ 2 plaques suitable for repeated biopsies and target lesion assessments. At least one of these lesions must be located on the extremities, preferably on the elbow or knee, with a minimal target lesion score between 6 and 9. Or, when currently using psoriasis medication and insufficient lesional skin is present, willing to discontinue treatment awaiting rescreening (see also exclusion criteria 3 for psoriatic patients);
    6. Willing to give written informed consent and willing and able to comply with the study protocol;
    E.4Principal exclusion criteria
    Healthy volunteers
    Eligible healthy volunteers must meet none of the following exclusion criteria at screening:
    1. History or symptoms of any uncontrolled, significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder that may interfere with the study objectives, in the opinion of the Investigator;
    2. History of immunological abnormality (e.g., immune suppression, severe allergy or anaphylaxis) that may interfere with study objectives, in the opinion of the Investigator;
    3. Known infection requiring antibiotic therapy within the last three months prior to the study;
    4. Immunosuppressive or immunomodulatory treatment within 30 days prior to the study;
    5. Body mass index (BMI) ≤ 18.0 or ≥ 40.0 kg/m2; during COVID-19 pandemic only ≤ 18.0 or > 33.0 kg/m2
    6. Participation in an investigational drug study within 3 months prior to screening or more than 4 times a year;
    7. Previous participation in an investigational drug study involving the dosing of an investigational compound targeting an immune pathway within one year prior to screening;
    8. Loss or donation of blood over 500 mL within three months prior to screening;
    9. The use of any medication or vitamin/mineral/herbal/dietary supplement within less than 5 half-lives prior to study participation, if the Investigator judges that it may interfere with the study objectives. The use of paracetamol (up to 4 g/day) and ibuprofen (up to 1 g/day) is allowed;
    10. History of alcohol consumption exceeding 5 standard drinks per day on average within 3 months of screening. Alcohol consumption will be prohibited from at least 12 hours preceding each study visit;
    11. Any other condition that could interfere with the conduct of the study or the study objectives, in the opinion of the Investigator.
    12. During COVID-19 pandemic: presence of high risk comorbidities: such as cardiovascular, respiratory or immune system disorders

    Psoriasis patients
    Eligible psoriasis patients must meet none of the following exclusion criteria at screening:
    1. Having primarily erythrodermic, pustular or guttate psoriasis;
    2. Having medication-induced psoriasis;
    3. Having previously failed on anti-IL23 therapy;
    4. Having received treatments for psoriasis within the following intervals prior to the start of the study:
    a. < 2 weeks for topical treatment, e.g. retinoids, corticosteroids, vitamin D analogs
    b. < 4 weeks for phototherapy, e.g. PUVA, PDT
    c. < 4 weeks for non-biologic systemic treatment, e.g. retinoids, methotrexate, cyclosporine, fumaric acid esters
    d. < 4 weeks for etanercept
    e. < 8 weeks for adalimumab
    f. < 3 months for anti-IL17, anti-IL12(/23) and anti-IL23 treatments
    5. History or symptoms of any significant uncontrolled disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder that may interfere with the study objectives, in the opinion of the Investigator, excluding psoriasis and conditions that are related to psoriasis;
    6. History of immunological abnormality (e.g., immune suppression, severe allergy or anaphylaxis) that may interfere with study objectives, in the opinion of the Investigator;
    7. Known infection requiring antibiotic therapy within the last 3 months prior to the study, including latent tuberculosis;
    8. Systemic immunosuppressive or immunomodulatory treatment within 30 days prior to the study;
    9. Body mass index (BMI) ≤ 18.0 or ≥ 40.0 kg/m2; during COVID-19 pandemic only ≤ 18.0 or > 30.0 kg/m2
    10. Participation in an investigational drug study within 3 months prior to screening or more than 4 times a year;
    11. Loss or donation of blood over 500 mL within three months prior to screening;
    12. The use of any medication or vitamin/mineral/herbal/dietary supplement within less than 5 half-lives prior to study participation, if the Investigator judges that it may interfere with the study objectives. The use of paracetamol (up to 4 g/day) and ibuprofen (up to 1 g/day) is allowed;
    13. History of alcohol consumption exceeding 5 standard drinks per day on average within 3 months of screening. Alcohol consumption will be prohibited from at least 12 hours preceding each study visit;
    14. Any other condition that could interfere with the conduct of the study or the study objectives, in the opinion of the Investigator.
    15. During COVID-19 pandemic: presence of high risk comorbidities: such as cardiovascular, respiratory or immune system disorders other than psoriasis and psoriasis arthritis
    E.5 End points
    E.5.1Primary end point(s)
    This study will monitor the change over time in:
    • Serum concentration of guselkumab and anti-guselkumab antibodies
    • Blood-based biomarkers (whole blood, serum and plasma samples)
    o Biomarkers will include, but are not limited to, cellular targets (e.g. T cells, TH17 cells, γδ T cells) from whole blood, comprehensive metabolomic and proteomic analysis from serum and/or plasma covering cytokines (e.g. IL-22, IL21, TNFα), chemokines (e.g. CCL20, CCL17, CXCL8), amines (e.g. amino acids, neurotransmitters) and inflammatory signalling lipids (e.g. prostaglandins, leukotrienes, isoprostanes).
    • Blister fluid-based biomarkers
    o Biomarkers will include, but are not limited to, cellular targets (e.g. T cells, TH17 cells, γδ T cells) and proteomic analysis covering cytokines (e.g. IL-22, IL21, TNFα), chemokines (e.g. CCL20, CCL17, CXCL8).
    • Skin biopsies for:
    o mRNA extraction for next-generation RNA sequencing
    o Histology by haematoxylin and eosin staining but might also include additional immunohistochemical stainings focussing on e.g. proliferation, complement activation and presence of cellular immune infiltrate.
    • Microbiome (skin, faecal)
    • Laser Speckle Contrast Imaging (LSCI)*
    • Thermography*
    • Clinical assessment (PASI, PGA,BSA)*
    • Colorimetry*
    • Optical coherence tomography (OCT)*
    • Multispectral imaging*
    • Total body photography (digital PASI)*
    • Patient reported outcomes (pruritus, sleeplessness, QoL, activity by smartwatch, at-home plaque monitoring)*
    • Skin surface markers*
    • Skin barrier function (TEWL)*
    • Lipidomics of stratum corneum by LC-MS*
    • Flow-mediated skin fluorescence (FMSF)*

    Endpoints marked ‘*’ denote non-invasive assessments. Note: if feasible, target areas for invasive measurements will also be investigated non-invasively over time. This will allow exploration of the correlation between molecular/cellular and functional measurements, and evaluation of wound healing.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day -14 - EOS
    E.5.2Secondary end point(s)
    N.A.
    E.5.2.1Timepoint(s) of evaluation of this end point
    N.A.
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) 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 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 years2
    E.8.9.1In the Member State concerned months6
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state50
    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 Decision2019-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-03-27
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