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    Summary
    EudraCT Number:2018-002299-41
    Sponsor's Protocol Code Number:KY1005-CT02
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-10-30
    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 - PEI
    A.2EudraCT number2018-002299-41
    A.3Full title of the trial
    A Phase IIa, Randomised, Double Blind, Placebo Controlled, Parallel Group, Multicentre Study of an Anti OX40L Monoclonal Antibody (KY1005) in Moderate to Severe Atopic Dermatitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of KY1005 in Patients with Moderate to Severe Atopic Dermatitis
    A.4.1Sponsor's protocol code numberKY1005-CT02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03754309
    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 SponsorKymab Limited
    B.1.3.4CountryUnited Kingdom
    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 supportKymab Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKymab Limited
    B.5.2Functional name of contact pointDevelopment Clinical Trial Desk
    B.5.3 Address:
    B.5.3.1Street AddressThe Bennet Building (B930), Babraham Research Campus
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB22 3AT
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailClinicaltrial@kymab.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 KY1005
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNKY1005
    D.3.9.2Current sponsor codeKY1005
    D.3.9.3Other descriptive nameKY1005 is a human anti-OX40 ligand (OX40L) monoclonal antibody
    D.3.9.4EV Substance CodeSUB187104
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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 placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atopic dermatitis
    E.1.1.1Medical condition in easily understood language
    Eczema
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    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 explore the efficacy and safety of KY1005 on the signs of atopic dermatitis (AD) using the Eczema Area and Severity Index (EASI) and the incidence of treatment-emergent adverse events (TEAEs).
    E.2.2Secondary objectives of the trial
    To explore/characterise:
    - To explore the effect of KY1005 on change in EASI over time
    - The effect of KY1005 on additional physician assessments of AD activity/severity (EASI, EASI 50, EASI 75, EASI 90, validated Investigator Global Assessment [vIGA], SCORing of Atopic Dermatitis [SCORAD] Index and affected body surface area [BSA]).
    - The effect of KY1005 on patient-reported AD activity/severity (Patient Oriented [PO] Eczema Measure [POEM], PO-SCORAD Index, Dermatology Quality of Life Index [DLQI] and Numerical Rating Scale [NRS] for pruritus).
    - The pharmacodynamic (PD) response to KY1005 including:
    ¤ change in histopathology;
    ¤ change in immunohistochemistry;
    ¤ the anti-KY1005 antibody response.
    - The pharmacokinetics (PK) of KY1005.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adults (≥ 18 years but < 75 years of age) with AD for 1 year or longer at Baseline (Day 1; prior to first administration of IMP).
    - EASI of 12 or higher at the Screening Visit and 16 or higher at Baseline.
    - vIGA of 3 or 4 at Baseline.
    - AD involvement of 10% or more of body surface area (BSA) at Baseline.
    - Documented history, within 6 months prior to Baseline, of either inadequate response to topical treatments or inadvisability of topical treatments.
    - Must have applied a stable dose of topical bland emollient (simple moisturiser, no additives [e.g., urea]) at least twice daily for at least 7 consecutive days before Baseline.
    - Able and willing to comply with requested study visits/telephone visits and procedures.
    - Able and willing to provide punch biopsy of both lesional and non-lesional skin at Baseline.
    - Able and willing to provide written informed consent.
    E.4Principal exclusion criteria
    - Treatment with any of the following prior to first IMP administration (Baseline):
    ¤ Systemic corticosteroids and tacrolimus within 4 weeks;
    ¤ Systemic cyclosporin A within 3 weeks
    ¤ Other systemic immunosuppressive or immunomodulatory drugs (including leukotriene inhibitors) within 3 months;
    ¤ Topical corticosteroids, tacrolimus or pimecrolimus, within 2 weeks;
    ¤ Prescription or non-prescription moisturisers with additives (e.g., urea, filaggrin) within 2 weeks;
    ¤ Phototherapy or allergen immunotherapy within 4 weeks;
    ¤ Regular use (> 2 visits/week) of a tanning booth/parlour within 4 weeks;
    ¤ Dupilumab within 3 months;
    ¤ Investigational therapy for the treatment of other conditions within 5 half-lives or the limit of PD effects or 3 months where the t1/2 is not known.
    - Known history of or suspected significant current immunosuppression, including history of invasive opportunistic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
    - Treatment with a live (attenuated) immunisation within 12 weeks prior to Baseline.
    - Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breast feeding.
    - Basal and squamous cell skin cancer in the last 3 years prior to Baseline. Any other malignancies in the last 5 years prior to Baseline (excluding in situ cervical carcinoma).
    - Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody at the Screening Visit.
    - Severe concomitant illness that would in the Investigator’s opinion inhibit the patient’s participation in the study, including for example, but not limited to, renal disease, neurological conditions, heart failure and pulmonary disease.
    - Laboratory values at the Screening Visit:
    ¤ Serum creatinine > 1.6 mg/dL (141 μmol/L) in female patients and > 1.9 mg/dL
    (168 μmol/L) in male patients;
    ¤ Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × upper limit of normal (ULN);
    ¤ Platelet count < 100 × 109/L;
    ¤ Haemoglobin (Hb): Male < 13.5g/dL and Female <12g/dL;
    ¤ White blood cell count (WBCC) < 3.0 × 109/L;
    ¤ Absolute neutrophil count < 2.0 × 109/L;
    ¤ Absolute lymphocyte count < 0.5 × 109/L;
    ¤ Total bilirubin > ULN. (except in circumstances where Gilbert's
    Syndrome can be confirmed).
    - Participation in any other clinical study, including non-interventional studies.
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary endpoints:
    - Percentage change in EASI from Baseline to Day 113.
    - Incidence of TEAEs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Percentage change in EASI: from Baseline to Day 113
    - Incidence of TEAEs to Day 113
    E.5.2Secondary end point(s)
    Main secondary endpoints:

    Efficacy endpoint:
    - Percentage and absolute change from Baseline in EASI over time.

    PD and histopathology endpoints:
    - Change in epidermal thickness from Baseline to Day 113.
    - Change in immunohistochemistry staining from Baseline to Day 113.

    Additional secondary endpoints:

    Efficacy endpoints:
    - Percentage of patients with at least a 50% reduction from Baseline in EASI (EASI 50) to Day 113.
    - Percentage of patients with at least a 75% reduction from Baseline in EASI (EASI 75) to Day 113.
    - Percentage of patients with at least a 90% reduction from Baseline in EASI (EASI 90) to Day 113.
    - Change in vIGA from Baseline to Day 113 and over time.
    - Percentage of patients with a response of vIGA 0 or 1 at Day 113 and over time.
    - Change in SCORAD Index from Baseline to Day 113 and over time.
    - Change in affected BSA from Baseline to Day 113 and over time.
    - Change in POEM from Baseline to Day 113 and over time.
    - Change in PO-SCORAD Index from Baseline to Day 113 and over time.
    - Change in DLQI from Baseline to Day 113 and over time.
    - Change in NRS for pruritus from Baseline to Day 113 and over time.

    PD endpoints:
    - Immunogenicity titres at various timepoints from Baseline to Day 113.

    Pharmacokinetic endpoints for each patient (receiving KY1005) including:
    - Cmax
    - tmax
    - Cmin
    - AUC
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various timepoints for all endpoints assessment will be from Baseline to Day 113 and over time where indicated.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Proteinomic, transcriptomic and histopathological assessment
    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 trial3
    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 EEA20
    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 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 years1
    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 years1
    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: 71
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 84
    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 Decision2018-11-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-14
    P. End of Trial
    P.End of Trial StatusCompleted
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